Accepted Manuscript Sacrocolpopexy for the Treatment of Vaginal Apical Prolapse: Evidence Based Surgery Ilana L. Parkes, MBBS (Hons) David Shveiky, M.D PII:

S1553-4650(14)00034-X

DOI:

10.1016/j.jmig.2014.01.004

Reference:

JMIG 2226

To appear in:

The Journal of Minimally Invasive Gynecology

Received Date: 19 July 2013 Revised Date:

29 December 2013

Accepted Date: 6 January 2014

Please cite this article as: Parkes IL, Shveiky D, Sacrocolpopexy for the Treatment of Vaginal Apical Prolapse: Evidence Based Surgery, The Journal of Minimally Invasive Gynecology (2014), doi: 10.1016/ j.jmig.2014.01.004. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

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ACCEPTED MANUSCRIPT

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Sacrocolpopexy for the Treatment of Vaginal Apical Prolapse: Evidence Based Surgery.

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Ilana L Parkes, MBBS (Hons) and David Shveiky,

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M.D.

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Section of Female Pelvic Medicine and Reconstructive Surgery. Department of

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Obstetrics and Gynecology, Hadassah – Hebrew University Medical Center, Ein

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Kerem, Jerusalem, Israel.

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Corresponding Author: David Shveiky, M.D., Department of Obstetrics and

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Gynecology, Hadassah – Hebrew University Medical Center, Ein Kerem, Jerusalem,

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Israel. Tel: 972-2-6777111, Fax: 972-2-6997691, E-mail: [email protected]

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Précis: Procedural steps and controversies in sacrocolpopexy are discussed and

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recommendations are made based on the level of the existing evidence.

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ACCEPTED MANUSCRIPT 21

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Abstract:

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Pelvic organ prolapse (POP) is a common condition that negatively affects women’s’

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quality of life. Sacrocolpopexy is an abdominal procedure designed to treat apical

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compartment prolapse, including uterine or vaginal vault prolapse, as well as multi-

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compartment prolapse. Although traditionally performed as an open abdominal

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procedure, minimally invasive sacrocolpopexy, laparoscopic or robotic, has been

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successfully adopted to the practice of many pelvic reconstructive surgeons. Many

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variations to this procedure exist, with different levels of evidence to support each

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one of them. In this article we review the current literature on sacrocolpopexy, with

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an emphasis on the minimally invasive approach. Procedural steps and

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controversies are examined in light of the existing literature and recommendations

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made based on the level of the existing evidence.

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Keywords: Sacrocolpopexy, robotic surgery, laparoscopy, mesh, surgical technique,

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evidence.

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Introduction:

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Pelvic organ prolapse (POP) is a common condition that negatively affects the

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quality of life of up to 40% of all women (1, 2). Many surgical procedures are

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designed to treat multiple compartment prolapse; however, high quality data

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comparing outcomes from these procedures are scarce (3, 4). Reoperation rates for

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prolapse surgery are high, especially in the anterior and apical compartments (2). In

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an attempt to improve anatomical cure rates, biologic and synthetic mesh grafts have

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been developed to improve tissue strength. Mesh can be implanted through the

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abdominal or vaginal route, with vaginal mesh becoming popular over the past

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decade due to its minimal invasiveness and satisfactory anatomical outcomes.

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However, conflicting data on the use of vaginal mesh cast some doubt on the benefit

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of utilizing this technology. Vaginal mesh seems to improve anatomical outcome at

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the anterior and apical compartments; but most studies failed to demonstrate

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subjective improvement in symptoms and quality of life with vaginal mesh as

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compared to native tissue repair (5). Moreover, the FDA recently issued a public

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health notification stating that serious adverse events are not rare in vaginal mesh

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surgery. In its review of the literature, abdominal prolapse repair with mesh was

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found to be associated with fewer mesh-specific complications than vaginal prolapse

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repair with mesh (6), a finding which – at least in relation to mesh complications –

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supports the abdominal approach as a potentially safer and more effective means of

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repairing pelvic organ prolapse.

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Abdominal sacrocolpopexy (ASC), first described in 1957 by Lane to treat vaginal

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vault prolapse after hysterectomy, is considered the most durable procedure for

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ACCEPTED MANUSCRIPT repair of POP, with reported long term success rates of 68-100% (7). In this

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procedure, an abdominal approach is used to attach a mesh graft to the anterior and

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posterior walls of the vagina and anchor it to the anterior longitudinal ligament (ALL)

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at the sacral promontory. Despite its excellent cure rates and durability, the potential

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morbidity of this open abdominal procedure has motivated surgeons and researchers

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to evaluate more minimally invasive approaches. ASC can also be performed

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laparoscopically, with reported short term cure rates similar to those of the open

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approach (8). Nevertheless, this procedure involves extensive suturing and

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retroperitoneal dissection requiring advanced laparoscopic skills. The Robotic

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sacrocolpopexy (RSC) utilizes a new tool for the performance of minimally-invasive

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POP repair - the DaVinci™ (Intuitive Surgical, Sunnyvale, CA) surgical system. This

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approach incorporates the potential durability of an abdominal repair with the

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minimal invasiveness of robotic surgery. Short term data show that RSC is safe and

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efficacious with short term anatomical outcome comparable to that of the open and

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laparoscopic approaches (9-15). While adhering to the basic principles of this

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procedure, many variations in surgical technique exist; however, only limited good

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quality data exist to support one technique over the other.

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In this article we sought to review the current literature regarding sacrocolpopexy.

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We focus on efficacy and safety, impact of patient risk factors on outcome as well as

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data on minimally invasive approaches to this procedure. In addition, while most data

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exist for the open procedure, we highlight specific surgical steps and issues involved

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with the minimally invasive approaches of laparoscopy and robotics, as they apply to

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sacrocolpopexy.

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Patient Selection

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ACCEPTED MANUSCRIPT Sacrocolpopexy is a procedure designed to repair apical support defects. Although

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originally described as a treatment for vaginal vault prolapse, it is widely utilized

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today for the treatment of uterine prolapse as well. In case of uterine prolapse,

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hysterectomy is usually completed prior to sacrocolpopexy. Uterine preservation or

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hysteropexy will not be discussed in this review. In many cases of anterior and

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posterior vaginal wall prolapse, there is also an apical component. Careful evaluation

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of the patient is required in order to diagnose multi-compartment prolapse. Such

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diagnosis is crucial for selection of the most appropriate surgical option.

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The role of sacrocolpopexy as a primary surgery for prolapse was never consistently

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studied. As patients with more advanced prolapse have a higher risk of recurrence

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(15), sacrocolpopexy, with its high durability and success rates, may be considered

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as a good option for primary repair in these patients.

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As compared to vaginal prolapse repair, sacrocolpopexy, either open or laparoscopic

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/ robotic, is generally a longer procedure that requires general anesthesia and steep

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Trendelenburg positioning. Therefore, some patients with medical comorbidities may

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not be considered ideal candidates for such a procedure. In patients with surgical

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risk factors, the benefits of this longer surgery should be weighed against its risks,

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especially when potentially safer and less invasive vaginal alternatives exist (5). In

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these high-risk patients, sacrocolpopexy may be reserved for cases of recurrent

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prolapse as a secondary treatment option; however, this has not been proven by

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scientific data. The durability of sacrocolpopexy and its potential benefits for sexual

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function (preservation of vaginal length and axis and lower rates of dyspareunia)

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make this procedure a good option for relatively young, sexually active women. In a

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study comparing robotic sacrocolpopexy (RSC) to vaginal mesh colpopexy, RSC

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ACCEPTED MANUSCRIPT patients were more likely to be younger, leaner, sexually active and have fewer

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medical comorbidities (16). This reflects surgeons' preference for younger and

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healthier patients for sacrocolpopexy. No randomized trial exists to support this

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practice. Recent data challenge traditional beliefs regarding some surgical risk

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factors. A study by Bradley et al. showed that most outcomes and complication

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rates after open sacrocolpopexy were similar in obese and healthy-weight women

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(17). Another study showed that robotic surgery was associated with fewer

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postoperative complications than vaginal surgery in elderly women. The authors

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concluded that either the vaginal and robotic route may be reasonable in the elderly

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population (18). The surgeon should be aware of the variety of surgical risk factors,

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including advanced age, obesity and medical comorbidities in selecting the

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procedure of choice for prolapse repair.

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Efficacy of Sacrocolpopexy

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Abdominal sacrocolpopexy (ASC) is considered one of the most durable procedures

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for the repair of vaginal vault prolapse. In a comprehensive review of ASC in 2004,

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Nygaard et al. reported cure rates of 78-100% when defined as lack of apical

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prolapse postoperatively, and 58-100%, when defined as no postoperative prolapse

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(7). Since this frequently cited comprehensive review of ASC, many studies have

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been performed evaluating this procedure, some of them providing high quality data.

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More studies rigorously assessed pelvic symptoms, urinary and bowel function,

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sexual function and quality of life using standardized and validated tools. Also, newer

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studies have been published, assessing minimally invasive laparoscopic or robotic

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assisted sacrocolpopexy.

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In a randomized controlled trial comparing sacrocolpopexy with and without Burch colposuspension to prevent Stress Urinary Incontinence (SUI) – the CARE trial –

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Brubaker et al. reported cure rates as high as 95% at the vaginal apex in women 2

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years after abdominal sacrocolpopexy. At 2 year follow-up fewer than 4% of women

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required reoperation for prolapse (14). Patient satisfaction rates and quality of life

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measures also showed sustainable improvement from baseline. Abdominal sacral

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colpopexy has compared favorably to vaginal procedures for apical suspension,

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such as the sacrospinous fixation. A 2010 Cochrane review reported a lower rate of

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recurrent vault prolapse, reduced grade of residual prolapse, greater length of time

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taken for prolapse to reoccur and less dyspareunia in ASC as compared with vaginal

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apical prolapse repair (5). Another study by Maher et al. comparing laparoscopic

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sacrocolpopexy with total vaginal mesh also demonstrated superior results for

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sacrocolpopexy: at 2-year follow up the objective cure of LSC was 77% compared

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with 43% in the vaginal mesh group. Reoperation rate was 5% compared with 22%

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after the vaginal mesh procedure (19). A recent prospective study from France

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reported the impact of LSC on symptoms, quality of life and sexuality. Pelvic Floor

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Distress Inventory (PFDI-20) score, significantly improved 3 and 12 months after

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LSC. Quality of life, as reflected by Pelvic Floor Impact Questionnaire, PFIQ-7 was

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also significantly improved as well as sexual function as reflected by the Pelvic organ

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prolapse urinary Incontinence Sexual Questionnaire (PISQ-12). (20).

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In contrast to the improvement in prolapse symptoms, urinary symptoms and quality

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of life that are generally seen after sacrocolpopexy, the effect of sacrocolpopexy on

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bowel symptoms is less clear. In a retrospective study of 77 women who underwent

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robotic sacrocolpopexy, only 56% of patients reported an improvement in outlet

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ACCEPTED MANUSCRIPT constipation 1 year postoperatively. Also, 11.6% had de-novo outlet constipation

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(21).

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It is important to note that when defining success of a procedure in subjective terms,

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such as improvement in patients' symptoms, quality of life and patient satisfaction,

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the lack of uniformity in outcome measuring tools and the subjectivity of outcomes

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make it difficult to draw clear conclusions. Keeping in mind this limitation, Nygaard et

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al. reported patient satisfaction or complete relief of symptoms to be as high as 85-

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100% (7)

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The issue of follow-up in studies involving sacrocolpopexy also deserves mention, as

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both length and completeness of follow-up varies considerably between studies. In

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2002 Culligan et al. performed a large retrospective cohort study on 245

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sacrocolpopexy patients, with specific focus on follow-up in an effort to establish the

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natural history of the procedure. This investigation found that almost 95% of

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objective failures occur within the first 24 months post-operatively, a conclusion

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which highlights the importance of long-term follow-up studies of 2 years or more

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(22). A recent long-term follow-up study of CARE trial participants by Nygaard et al.

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concluded that at 7 year follow up there was an increased rate of failure of ASC, on

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both objective and subjective measures. In this study the authors also calculated the

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probability of mesh erosion over 7 years follow up to be 10.5% (23).

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Minimally invasive sacrocolpopexy

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The main disadvantages of ASC - relatively high complication rate, length of hospital

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stay, postoperative pain and the delayed return to activity (5) - have led many

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surgeons to limit or completely abandon the abdominal approach to POP repair in

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their practice. The need for a minimally invasive procedure that incorporates the cure

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ACCEPTED MANUSCRIPT rate and durability of an abdominal repair has recently been addressed by the

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accumulating data on laparoscopic and robotic sacrocolpopexy. In both laparoscopic

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and robotic sacrocolpopexy, all surgical principles of ASC are being followed, yet

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using a minimally invasive approach. In a recent British RCT comparing open to

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laparoscopic sacrocolpopexy, the two procedures had similar anatomical success

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rates with less blood loss, higher haemoglobin level and shorter hospital stay for

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LSC (24). Also, these procedures are generally believed to be associated with better

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cosmetic results (25). Nevertheless, the necessity of high level laparoscopic skills

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may limit the popularity of this procedure.

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Robotic sacrocolpopexy (RSC), using the DaVinci™ (Intuitive Surgicals, Sunnyvale,

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CA) surgical system, is a new technique for the performance of minimally invasive

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sacrocolpopexy, which may overcome some of the difficulties associated with

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conventional laparoscopy. Since its approval by the FDA in 2005, the DaVinci robot

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has gained popularity among pelvic reconstructive surgeons, enabling more

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surgeons to perform minimally invasive sacrocolpopexy. There is evidence that

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surgical tasks may be more easily learned by trainees in the robotic system as

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compared with conventional laparoscopy. In 2011, Kho reviewed the literature

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regarding surgical task acquisition and performance in the robotic platform as

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compared to conventional laparoscopy. The authors concluded that in the laboratory

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setting, the learning curve was less steep in the robotic platform than in conventional

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laparoscopy. This is yet to be proven in a clinical setting (26).

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The robotic system offers improved visualization with three-dimensional view as well

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as significantly improved dexterity due to the wide motion and articulation range of

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the robotic tip unit. The main disadvantage of the robotic system is the higher cost as

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ACCEPTED MANUSCRIPT compared to ASC or LSC. Another important disadvantage of the robotic system is

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the lack of haptic feedback during surgery. In recent years, clinical data is

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accumulating in the literature with regard to surgical outcomes of LSC and RSC,

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showing comparable outcomes to ASC in the treatment of POP. Tables 1 and 2

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summarize data on laparoscopic and robotic sacrocolpopexy respectively, which is

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discussed here in more detail.

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Minimally invasive versus open sacrocolpopexy

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In a recent prospective study of 148 women undergoing LSC, the anatomical cure

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rate was 93.7% at 12 months (20). In a recent large study comparing LSC and RSC

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to ASC among medicare beneficiaries, minimally invasive sacrocolpopexy was

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associated with a higher rate of reoperation for anterior wall prolapse compared to

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ASC (3.4% vs. 1%, p=0.018). However, more medical (primarily cardiopulmonary)

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complications were reported post-operatively in the open group (31.5 % vs 22.7 %,

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p = 0.023) (27). Elliot et al. have reported success rates of 94% in a series of 30

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patients undergoing RSC with a follow-up of up to 24 months (10). Belsante et al

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reported no recurrent vault prolapse as well as a statistically significant improvement

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in quality of life reports in 35 patients who underwent RSC, with a median follow-up

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time of 28 months (28). More recently Geller et al. reported similar short-term vaginal

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vault support in RSC and open sacrocolpopexy with longer operative time, less blood

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loss, and shorter length of stay in RSC (12). A follow-up study at 44 months of the

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same cohort demonstrated comparable long-term rates of success for both open and

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robotic procedures, using both objective and subjective measures (29). Freeman et

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al. performed a multi-center RCT in the UK, comparing LSC to ASC. The subjective

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cure rates for ASC and LSC were 90% and 80% respectively (NS) with less blood

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ACCEPTED MANUSCRIPT loss and a shorter hospital stay for LSC (24). Siddiqui et al. recently showed

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comparable outcome of RSC, performed by a single surgeon, to the outcome of ASC

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patients who participated in the CARE trial (30).

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Laparoscopic versus robotic sacrocolpopexy

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In a small retrospective study, we compared short term outcome and operative time

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between conventional laparoscopic and robotic sacrocolpopexy. Similar anatomical

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cure rates were found in the two groups. Further, there was no difference in the rate

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of peri-operative complications or operating time (13). In contrast, in a randomized

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controlled trial, Parasio et al. reported longer operating time and increased post-

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operative pain in RSC compared to the conventional laparoscopic approach,

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although with similar anatomical outcomes. With regard to costs, the authors found

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the cost of RSC to be $1936 higher than LSC (31). However, a different cost

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analysis concluded that with sufficient institutional case volume, RSC can be even

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less costly than open ASC (32).

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To date, given the existing evidence regarding outcome of LSC and RSC, both

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procedures should be considered comparable and the choice to perform each of

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them is based on personal preference and skills of the surgeon.

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Complications

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Complications of ASC include general surgical complications as well as some more

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unique to this procedure. In their review of open ASC, Nygaard et al. found a total

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complication rate of 14.6% (7). The more significant complications related to

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sacrocolpopexy are discussed here in further detail.

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ACCEPTED MANUSCRIPT It should be noted that open ASC is associated with higher rate of medical,

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especially cardiopulmonary, complications as compared to LSC or RSC (26).

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In addition, a systematic review focused on complications and reoperation rates

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concluded that the rate of overall serious complications requiring reoperation, as

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measured using the Dindo grading system, is lower in sacrocolpopexy than prolapse

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surgery performed vaginally, either with native tissue or mesh (33).

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Bleeding complications: During pre-sacral dissection, bleeding may occur from the

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iliac vessels and, uniquely to this procedure, from the middle sacral vessels at the

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sacral promontory. Nygaard describes this complication as “uncommon” but “one of

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the most worrisome” (7). The overall median rate of bleeding complications was

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4.4% (7).

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Urinary tract complications: In Nygaard’s review of sacrocolpopexy, the most

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common complication reported was urinary tract infection, with a median rate of

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10.9% (7). Injury to the urinary tract is less common but not rare. In 11 studies which

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noted bladder injury, the median rate was 3.1%. The reported median rate of

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damage to the ureter was 1.0%, however only four studies discussed this

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complication.

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Gastrointestinal complications: A secondary analysis of the CARE trial, focusing on

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gastrointestinal complications of ASC, found 5.9% of participants experienced

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serious gastrointestinal complications (small bowel obstruction (SBO) or ileus) after

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ASC. Only 1.2% required reoperation for serious GI complications. The authors

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noted that this rate of serious gastrointestinal complications for ASC is comparable

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to other open gynecological procedures. In this study, no intra-operative bowel

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ACCEPTED MANUSCRIPT injuries were reported (34). Nygaard noted a median rate of bowel injury of 1.6% (6).

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Similarly, in a recent retrospective study focusing on gastrointestinal complications of

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LSC, among 390 patients, Warner et al. found a rate of 1.3% for intraoperative bowel

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injury (3 small bowel and 2 rectal injuries). This study reported a rate of 1% for

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combined ileus and SBO (35). Interestingly, prior abdominal surgery was positively

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associated with functional GI complications (ileus, SBO, nausea), but not with bowel

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injury.

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Mesh complications: In their systematic review, Jia et al reported that mesh erosion

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rates for sacrocolpopexy varied between 0-12 percent. This compared to rates of 0-

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21% for infracoccygeal sacropexy (36). In their 2004 review of ASC, Nygaard and

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colleagues reported an overall rate of mesh erosion of 3.4% (7). Similarly, Visco et

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al. reported the rate of mesh erosion for ASC to be 3.2%, compared to 4.5% for

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abdominal sacral colpoperioneopexy, where the posterior mesh is attached to the

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perineum, and to over 16% for procedures in which the mesh was sutured vaginally.

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In this study the mean time to diagnosis of mesh erosion in the ASC group was 15.6

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months (37).

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Vertebral discitis: Vertebral discitis at the L5-S1 level, or even osteomyelitis, may

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occur as a result of mesh or suture placement in the sacral area. This is a rare but

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serious complication which may necessitate reoperation for debridement and

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removal of the infected mesh. There are several reports on this complication (38-40).

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Muffly et al. reported a case of lumbosacral osteomyelitis presented with increasing

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back pain and foul-smelling vaginal drainage (39). Such cases have been reported

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up to 5 years after surgery.

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ACCEPTED MANUSCRIPT Nerve injury: Laparoscopic and robotic sacrocolpopexy may have additional

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complications that are unique to the laparoscopic approach. Both procedures are

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involved with prolonged lying in the lithotomy position and require steep

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Trendelenburg. As a result, there is an increased risk of positioning-related nerve

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injury, especially to the posterior tibial and femoral nerves in the lower limbs and to

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the brachial plexus at the upper limbs and shoulder girdle (41). Special measures

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should be taken to prevent such injuries, including proper patient positioning,

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prevention of patient sliding down the table during the procedure and minimizing

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operative time.

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Common Surgical Controversies

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Hysterectomy: Total versus supra-cervical: In cases of uterine prolapse, many

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surgeons prefer to perform hysterectomy prior to sacrocolpopexy. When uterine

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preservation is desired, sacrohysteropexy may be considered; however, the

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discussion of this procedure is beyond the scope of this article. While total

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hysterectomy may have the advantage of prevention of future cervical pathology,

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supracervical hysterectomy may be an alternative after exclusion of cervical

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dysplasia. Although sometimes offered as a safer alternative to total hysterectomy,

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this assertion is not supported by level 1 evidence. In fact, all 3 randomized trials

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comparing open supracervical to total hysterectomy did not show significant

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differences in perioperative morbidity or in urinary or sexual function (42). However,

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in a retrospective study, laparoscopic SCH has been shown to be associated with

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less blood loss and complications compared to laparoscopically assisted vaginal

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hysterectomy (43). Theoretically, from the pelvic support perspective, the residual

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apical support provided by the uterosacral ligaments may also be an advantage (44).

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ACCEPTED MANUSCRIPT In an analysis of 322 participants of the CARE trial, concurrent total hysterectomy

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was found to be a modifiable risk factor for mesh erosion after sacrocolpopexy (45).

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In another retrospective study of 390 LSCs, open cuff hysterectomy was significantly

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associated with mesh erosion as compared to supracervical hysterectomy (4.9% vs.

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0% p=0.032) (46). With regard to vaginal hysterectomy, Tan Kim et al. found this to

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be a significant risk factor for mesh erosion in sacrocolpopexy with up to 23%

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erosion rates (47).

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Recommendation: Overall, it appears that when hysterectomy is indicated,

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supracervical hysterectomy may have a benefit over total hysterectomy or

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transvaginal hysterectomy in reducing mesh erosion and overall complication rates.

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Level of evidence – 2b

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What graft and suture material to choose? Several studies address the question of

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which graft material should be used in ASC. Tate et al. conducted a randomized

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controlled trial comparing cadaveric fascia lata graft to synthetic polypropylene mesh

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for ASC. At 5 year follow up, objective anatomical success rates were 93% and 62%

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(p=0.02) for polypropylene mesh and fascia lata graft respectively (48). In a recent

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randomized controlled trial, Culligan et al. compared surgical outcome of

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laparoscopic sacrocolpopexy using either porcine dermis or polypropylene mesh.

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They found similar objective cure rates (80.7% and 89.2%, NS) using porcine graft

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and synthetic mesh respectively (49). A retrospective study by Quiroz et al. found

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more apical failures in ASC using porcine acellular collagen matrix graft (11%) as

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compared with polypropylene mesh (1%) or autologous fascia (7%). All reoperations

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occurred in the porcine acellular collagen matrix group. This graft was also

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associated with higher graft-related complications (50). In a recent prospective study,

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ACCEPTED MANUSCRIPT Salamon et al. found objective and clinical cure rates of 89% and 94% respectively,

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in RSC using ultra-lightweight polypropylene mesh, with no mesh complications (51).

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Significant heterogeneity also exists between different synthetic mesh products (52).

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A recent study compared the ex-vivo strength, stiffness and degree of permanent

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deformation found in 7 different commercial vaginal meshes. In general, lighter-

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weight meshes (ie. more porous meshes) were less stiff but had decreased tensile

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strength (52). Nevertheless this is an ex-vivo study upon which we cannot base clear

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clinical recommendations.

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With regard to suture selection, one study found no suture or mesh erosion in 254

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patients in whom monofilament delayed absorbable suture (PDS, Ethicon,

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Somerville, New Jersey) was used, as compared with 3.7% when braided permanent

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suture (Ethibond, Ethicon, Somerville, New Jersey) was used, with a similar

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anatomical outcome over the two groups (53). In a case series of 22 patients with

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infected mesh after ASC, 15 had a polytetrafluoroethylene (PTFE, Goretex) mesh. In

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82% of them, the mesh was attached to the vagina using a braided permanent

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suture (54). In order to facilitate suturing, unidirectional barbed sutures are

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sometimes used in sacrocolpopexy for attaching the mesh to the vagina or for

367

peritoneal covering of the mesh. One study has shown its feasibility and safety in

368

pelvic reconstructive surgery; however, the existing data is insufficient for drawing

369

any conclusion (55).

M AN U

TE D

EP

AC C

370

371

SC

RI PT

350

Recommendations:

17

ACCEPTED MANUSCRIPT •

Ib

373 374





ASC is more likely to fail with porcine acellular collagen matrix graft than with synthetic or autologous grafts. Level of evidence – 2b

377



The use of ultra-lightweight polypropylene mesh for robotic sacrocolpopexy

SC

378

Porcine dermis and polypropylene mesh yield comparable short term cure rate in laparoscopic sacrocolpopexy. Level of evidence: Ib

375 376

Polypropylene mesh is superior to fascia lata graft in ASC. Level of evidence

RI PT

372

may limit mesh-related complications in the first postoperative year, with

380

significant improvement in subjective and objective outcomes. Level of

381

evidence 2b

382



M AN U

379

Monofilament delayed absorbable sutures may reduce suture or mesh erosion rates in ASC. Level of evidence – 2b

383

TE D

384

“Y” mesh versus two separate mesh pieces

386

The use of a pre-formed "Y" mesh may facilitate mesh placement and shorten the

387

procedure; however, many surgeons prefer to use two separate pieces of mesh for

388

the anterior and posterior vagina. The advantage of this approach is that each piece

389

can be individually tensioned at the surgeon's preference. No data exist in the

390

literature comparing these two approaches.

391



AC C

EP

385

Recommendation: There is no evidence to support using a pre-formed “Y”

392

mesh or 2 separate mesh pieces for sacrocolpopexy. This controversy is yet

393

to be studied.

394

18

ACCEPTED MANUSCRIPT How low in the vagina should the graft be placed? One of the most common

396

controversies regarding the technique of sacrocolpopexy is the extent of dissection

397

and mesh placement in the vagina. While many surgeons dissect the vesico-vaginal

398

space to the level of the urethro-vaginal junction and the recto-vaginal space to the

399

level of the levator ani muscles, others choose to limit this dissection in an attempt to

400

reduce the risk of cystotomy or enterotomy. The value of low mesh placement in

401

both the anterior and posterior compartments has not been examined in a

402

randomized controlled trial. In 1997, Cundiff et al. described the abdominal sacral

403

colpo-perineopexy procedure for correction of posterior defect and perineal descent

404

(56). In this procedure, the recto-vaginal space was dissected to the superior aspect

405

of the posterior vaginal fascia still contiguous with the perineal body and synthetic

406

mesh was sutured to the posterior vagina. At short term follow-up, 8 of 11 patients

407

reported improved bowel symptoms. Nevertheless, in an evaluation of the long term

408

impact of this procedure on obstructive defecatory symptoms by the same

409

researchers, 85% of patients reported obstructed defecation at 5 year follow-up. The

410

authors concluded that sacral colpoperineopexy is unlikely to eliminate obstructed

411

defecatory symptoms (57). In a French prospective study of 90 patients undergoing

412

laparoscopic sacral colpoperineopexy, anorectal symptoms significantly worsened at

413

30.7 months follow-up. De-novo straining (27%) and the need for digital assistance

414

(17%) were the most frequent anorectal symptoms (58). Finally, in their

415

retrospective study of mesh erosion after ASC, Visco et al. found no difference in

416

mesh erosion rates between ASC and sacral colpoperineopexy when the mesh was

417

sutured abdominally (59).

AC C

EP

TE D

M AN U

SC

RI PT

395

19

ACCEPTED MANUSCRIPT Recommendation: Based on prospective non-randomized studies, abdominal and

419

laparoscopic sacral colpoperineopexy is associated with no improvement and even

420

worsening of obstructive defecatory symptoms. Level of evidence – 2b

421

Sacrocolpopexy for the treatment of anterior compartment prolapse

422

Many patients with apical prolapse also have anterior vaginal prolapse (60).

423

Correction of the vaginal apical support is important for any prolapse repair. In

424

sacrocolpopexy, mesh graft is sutured to the anterior and posterior vaginal walls.

425

Despite the fact that most recurrences of prolapse occur in the anterior wall, only a

426

small number of studies specifically address cure of anterior wall defect as a primary

427

outcome. Some surgeons added paravaginal repair to ASC in order to correct

428

cystocele. In a survey of 963 American Urogynecologic Society members, most

429

responders considered the anterior vaginal graft sufficient to address cystocele at

430

the time of abdominal sacrocolpopexy (61). In a retrospective cohort study

431

comparing outcomes for 170 patients undergoing sacrocolpopexy with and without

432

concomitant paravaginal repair, Shippey et al. were unable to detect statistically

433

significant difference in recurrence rate of cystocele between the groups (62). In

434

another retrospective study, Gilleran et al. reported an 8% recurrence rate for

435

cystocele 6 months after ASC, with significant improvement in all compartments (63).

436

Recommendation: Anterior mesh placement at sacrocolpopexy may be sufficient for

437

cystocele repair. Level of evidence – 2b

438

439

AC C

EP

TE D

M AN U

SC

RI PT

418

20

ACCEPTED MANUSCRIPT Concomitant posterior repair during sacrocolpopexy:

441

Elevating the vaginal apex may correct support defects at the anterior and posterior

442

vaginal walls. A study by Guiahi et al. measured the topography of the anterior and

443

posterior vaginal walls using the POP-Q system pre-and 1 year after ASC. Anterior

444

compartment was the most common site of POP persistence or recurrence, followed

445

by posterior compartment and vaginal apex. They found ASC sufficient to restore

446

posterior vaginal wall support in most women without concomitant posterior repair

447

(64). Another study by Crane et al. compared defecatory symptoms, specifically,

448

outlet obstruction in patients who underwent RSC with and without concomitant

449

posterior repair. There was no difference between the groups in obstructive

450

symptoms or in symptomatic posterior wall prolapse, 1 year after RSC. Overall,

451

11.7% underwent a subsequent posterior repair, none of whom had posterior repair

452

with the initial surgery (NS) (21).

453

Recommendation:

M AN U

SC



Concomitant posterior repair has no effect on outlet obstruction symptoms after RSC. Level of evidence 2b

457 458

TE D

concomitant posterior repair. Level of evidence 2b

455 456

Posterior vaginal wall defect is often corrected by ASC with no need for

EP



AC C

454

RI PT

440



There is a trend toward a reduced need for a subsequent posterior repair in

459

women who underwent this procedure with the initial surgery. Level of

460

evidence 2b

461

21

ACCEPTED MANUSCRIPT Sacral fixation techniques: In ASC, the mesh is fixed to the anterior longitudinal

463

ligament at the sacral promontory. The optimal number of sutures required to secure

464

the mesh into the ligament has not been studied. With regard to suture placement

465

and orientation, White et al. performed a cadaver study and found that sutures

466

placed at or above the sacral promontory are more secure than those placed below.

467

Horizontally oriented sutures were significantly stronger when compared with

468

vertically placed sutures (65). In relation to suture position, however, it should be

469

noted that although fixation at or above the sacral promontory may result in a

470

stronger stitch, increasingly cephalad suture placement has been demonstrated to

471

significantly alter the vaginal axis to a less anatomic position (66). Further, the

472

increasing proximity to the great vessels may increase the risk of injury to them.

473

Another potential complication of sacral fixation is lumbo-sacral discitis at the level of

474

L5-S1 disc. Abernethy et al. performed a MRI study examining the sacral promontory

475

and its relation to the intervertebral discs. They found the intervertebral disc to be

476

located at the promontory in 53% of participants. The authors suggested that suture

477

placement strategies which avoid this location may reduce disc-related sequelae

478

after sacrocolpopexy (67). Recently, Good et al. showed similar results in a cadaver

479

study. They found the L5-S1 disc to be the most prominent structure in the presacral

480

space. During sacrocolpopexy, the surgeon should recognize the 60-degree average

481

drop between the anterior surfaces of L5 and S1 and avoid the L5-S1 disc (68).

482

When placing the sutures caudal to the true sacral promontory, down the slope of

483

the sacrum, it is recommended to attach them to S1 rather than S2, based on a

484

study which found the pullout strength of sutures to be significantly higher at the S1

485

level than at the S2 level (69).

AC C

EP

TE D

M AN U

SC

RI PT

462

22

ACCEPTED MANUSCRIPT The use of bone anchors for securing of the mesh to the presacral area is gaining

487

popularity, as it may save time and avoid the need for laparoscopic suturing. In a

488

prospective cohort study, Withangen et al. reported excellent objective outcomes

489

(98%) at the apical compartment six months after LSC using bone anchor fixation,

490

with no osteomyelitis or discitis (70). It appears that the fear of L5-S1 discitis with

491

bone anchor screws is not based on solid data, but rather on a few case reports (71).

492

Despite this, were discitis to occur, management by removing bone anchors may be

493

more difficult than removing simple sutures.

494

Recommendations: •

SC

M AN U

495

RI PT

486

Sutures placed at or above the sacral promontory have a stronger pullout force. Sutures placed more cephalad have a stonger pullout force than those

497

placed more caudally, However, more cephalad placement of sutures may

498

result in a deviation of the vaginal axis. Level of evidence 5 •



EP

evidence 5

500

501

Horizontally oriented sutures are stronger than vertical sutures. Level of

The most prominent point of the sacral promontory is the L5-S1 disc and this

AC C

499

TE D

496

502

area should be avoided when placing sacrocolpopexy sutures. Level of

503

evidence 5

504



than at the S2 level. Level of evidence 5

505

506 507

The pullout strength of sutures placed at the S1 level is significantly higher



Bone anchor fixation of the mesh is associated with good anatomical outcomes with only case reports of lumbosacral discitis. Level of evidence 2c.

23

ACCEPTED MANUSCRIPT 508

Amount of tension in the vagina One of the most critical steps in sacrocolpopexy is to determine the appropriate

510

amount of apical suspention without undue tension that may cause pain or de-

511

novo stress incontinence. In a comprehensive review of the literature we did not

512

find any studies addressing the issue of optimizing vaginal tension.

RI PT

509

Peritoneal covering of the mesh:

514

After the vaginal vault is suspended, most practitioners cover the mesh with

515

peritoneum in an attempt to avoid bowel entrapment and internal hernia. This

516

complication has been reported in case reports (72). In their case series of 128

517

women undergoing ASC or LSC without burial of the mesh by peritoneal closure,

518

Elneil et al. reported no bowel complications. They concluded that it appears safe to

519

perform vault suspension without closing the peritoneum (Level of evidence 2C,

520

(73)). Nevertheless, the vast majority of surgeons do cover the mesh with

521

peritoneum in order to reduce potential morbidity of bowel entrapment and pelvic

522

adhesion. We cannot recommend changing this practice based on a single case

523

series and therefore prefer to cover the mesh.

524

What to do in an event of bladder or bowel injury?

525

In the unfortunate event of cystotomy or proctotomy during sacrocolpopexy, the

526

surgeon is facing the dilemma of whether to abort or continue the procedure after

527

repairing the injury. Aborting the procedure may leave the patient with prolapse,

528

increasing her dissatisfaction from the procedure; however, placing a mesh over a

529

repaired bladder or bowel, or after bowel resection, may increase the risk of mesh

AC C

EP

TE D

M AN U

SC

513

24

ACCEPTED MANUSCRIPT infection, erosion to the injured organ or fistula formation. In the previously cited case

531

series of mesh infection after ASC, one case occurred after bowel resection (54).

532

Currently, there is no data in the literature to direct the best practice in case or

533

bladder or bowel injury. This important controversy should be examined in a

534

multicenter study as these complications are not common.

535

Use of vaginal estrogen preoperatively and postoperatively

536

Vaginal estrogen is widely used to treat atrophic vaginitis and is commonly used as

537

an initial treatment of vaginal mesh erosion. The rationale for this treatment is that

538

replacing estrogen to the vagina may minimize surgical site wound infections by

539

altering the vaginal flora to premenopausal levels (74).

540

In a basic animal study by Higgins et al., estrogen replacement given to

541

ovariectomized rats reversed atrophic changes in the vagina and increased collagen

542

deposition into polypropylene mesh (75). In a small randomized controlled trial

543

examining the histological and cytological effects of preoperative vaginal estrogen in

544

women with POP, Vaccaro et al found a statistically significant increase in vaginal

545

maturity index after 7 weeks of use, but no increase in vaginal epithelial thickness

546

(76). The clinical significance of this finding is unclear. In a recent review of

547

complications and their prevention, de Tayrac R et al concluded that there is no

548

evidence to recommend routine local or systemic oestrogen therapy before or after

549

prolapse surgery using mesh (77). This common practice should be studied in a high

550

quality randomized controlled trial to assess its clinical relevance.

551

AC C

EP

TE D

M AN U

SC

RI PT

530

25

ACCEPTED MANUSCRIPT 552

Conclusion

554

Abdominal sacrocolpopexy is one of the best studied procedures for POP repair. It

555

has been found to be the most effective treatment for apical prolapse and should be

556

considered the gold standard procedure for this condition. Minimally invasive,

557

laparoscopic or robotic, sacrocolpopexy seems to have comparable short-term

558

outcome to the open abdominal approach, while affording patients the well-

559

recognised advantages of minimally-invasive surgery. While the surgical principles

560

remain the same, variations in surgical technique do exist. Keeping patient safety in

561

mind, adequate training in minimally invasive surgery as well as critical reading of

562

the scientific data is necessary in order to achieve the best surgical outcome.

M AN U

SC

RI PT

553

TE D

563 564

References:

566

1.

567

Prevalence of symptomatic pelvic floor disorders in US women. JAMA. 2008;

568

300(11):1311-6.

569

2.

570

pelvic organ prolapse and urinary incontinence. Obstet Gynecol 1997; 127: 380-7.

571

3.

572

quality-of-life outcomes after the Prolift procedure for treatment of posthysterectomy

573

prolapse. Am J Obstet Gynecol 2008; 199(6):694.e1-6.

EP

565

AC C

Nygaard I, Barber MD, Burgio KL, et al.; Pelvic Floor Disorders Network.

Olsen AL, Smith VJ, Bergstorm JO et al. Epidemiology of surgically managed

van Raalte HM, Lucente VR, Molden SM, et al. One-year anatomic and

26

ACCEPTED MANUSCRIPT 4.

Sung VW, Rogers RG, Schaffer JI et al. Graft use in transvaginal pelvic organ

575

prolapse repair: a systematic review. Obstet Gynecol 2008; 112(5):1131-42.

576

5. Maher C, Feiner B, Baessler K, Glazener CMA. Surgical management of pelvic

577

organ prolapse in women. Cochrane Database of Systematic Reviews 2010, Issue 4.

578

Art. No

579

6.

580

Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and

581

Stress Urinary Incontinence.

582

http://www.fda.gov/medicaldevices/safety/alertsandnotices/publichealthnotific

583

ations/ucm061976.htm.

584

7. Nygaard IE, McCreery R, Brubaker L et al.. Abdominal sacrocolpopexy: a

585

comprehensive review. Obstet Gynecol 2004; 104(4):805-23.

586

8. Sarlos D, Brandner S, Kots L et al. Laparoscopic sacrocolpopexy for uterine and

587

post-hysterectomy prolapse: anatomical results, quality of life and perioperative

588

outcome-a prospective study with 101 cases. Int Urogynecol J Pelvic Floor Dysfunct

589

2008; 19(10):1415-22.

590

9.

591

sacrocolpopexy/sacrouteropexy repair of advanced female pelvic organ prolaspe

592

(POP): utilizing POP-quantification-based staging and outcomes. BJU Int 2007;

593

100(4):875-9.

594

10.

595

laparoscopic sacrocolpopexy for the treatment of high grade vaginal vault prolapse. J

596

Urol 2006; 176(2): 655-9.

RI PT

574

EP

TE D

M AN U

SC

FDA Public Health Notification: Serious Complications Associated with

AC C

Daneshgari F, Kefer JC, Moore C et al. Robotic abdominal

Elliott DS, Krambeck AE, Chow GK. Long-term results of robotic assisted

27

ACCEPTED MANUSCRIPT 11. Di Marco DS, Chow GK, Gettman MT et al. Robotic-assisted laparoscopic

598

sacrocolpopexy for treatment of vaginal vault prolapse. Urology 2004; 63(2):373-6

599

12. Geller EJ, Siddiqui NY, Wu JM et al.. Short-term outcomes of robotic

600

sacrocolpopexy compared with abdominal sacrocolpopexy. Obstet Gynecol 2008

601

Dec; 112(6):1201-1206.

602

13. Antosh DD, Grotzke SA, McDonald MA, Shveiky D, Park AJ, Gutman RE, Sokol

603

AI. Short-term outcomes of robotic versus conventional laparoscopic sacral

604

colpopexy. Female Pelvic Med Reconstr Surg. 2012;18(3):158-61.

605

14. Brubaker L, Nygaard I, Richter HE, Visco A, Weber AM, Cundiff GW, Fine P,

606

Ghetti C, Brown MB. Two-Year Outcomes After Sacrocolpopexy With and Without

607

Burch to Prevent Stress Urinary Incontinence, Obstet Gynecol. 2008 July ; 112(1):

608

49–55.

609

15. Shveiky D, Iglesia CB, Sokol AI, Kudish BI, Gutman RE. Robotic sacrocolpopexy

610

versus vaginal colpopexy with mesh: choosing the right surgery for anterior and

611

apical prolapse. Female Pelvic Med Reconstr Surg. 2010; 16(2):121-7.

612

16. Whiteside JL, Weber AM, Meyn LA, Walters MD, Risk factors for prolapse

613

recurrence after vaginal repair. Am J Obstet Gynecol 2004; 191:1533–1538

614

17. Bradley CS, Kenton KS, Richter HE, Gao X, Zyczynski HM, Weber AM, Nygaard

615

IE; Pelvic Floor Disorders Network. Obesity and outcomes after sacrocolpopexy. Am

616

J Obstet Gynecol. 2008; 199(6):690.e1-8.)..: CD004014.

617

18. Robinson BL, Parnell BA, Sandbulte JT, Geller EJ, Connolly A, Matthews CA.

618

Robotic versus vaginal urogynecologic surgery: a retrospective cohort study of

RI PT

597

AC C

EP

TE D

M AN U

SC

.

28

ACCEPTED MANUSCRIPT perioperative complications in elderly women. Female Pelvic Med Reconstr Surg.

620

2013; 19(4):230-7.

621

19. Maher CF, Feiner B, DeCuyper EM, Nichlos CJ, Hickey KV, O’Rourke P,

622

Laparoscopic sacral colpopexy versus total vaginal mesh for vaginal vault prolapse:

623

a randomized trial. Am J Obstet Gynecol. 2011; 204(4):360

624

20. Thibault F, Costa P, Thanigasalam R, Seni G, Brouzyine M, Cayzergues L, De

625

Tayrac R, Droupy S, Wagner L. Impact of laparoscopic sacrocolpopexy on

626

symptoms, health-related quality of life and sexuality: a medium-term analysis. BJU

627

Int. 2013 Jun 13. doi: 10.1111/bju.12286. [Epub ahead of print]

628

21. Crane AK, Geller EJ, Matthews CA. Outlet constipation 1 year after robotic

629

sacrocolpopexy with and without concomitant posterior repair. South Med J. 2013;

630

106(7):409-14.

631

22. Culligan PJ, Murphy M, Blackwell L, Hammons G, Graham C, Heit MH. Long-

632

term success of abdominal sacral colpopexy using synthetic mesh. Am J Obstet

633

Gynecol. 2002 Dec;187(6):1473-80

634

23. Nygaard I, Brubaker L, Zyczynski HM, Cundiff G, Richter H, Gantz M, Fine P,

635

Menefee S, Ridgeway B, Visco A, Klein Warren L, Zhang M, Meikle S. Long-term

636

outcomes following abdominal sacrocolpopexy for pelvic organ prolapse, JAMA,

637

2013;309(19):2016-2024

638 639

AC C

EP

TE D

M AN U

SC

RI PT

619

24. Freeman RM, Pantazis K, Thomson A, Frappell J, Bombieri L, Moran P, Slack M, Scott P, Waterfield M. A randomised controlled trial of abdominal versus

29

ACCEPTED MANUSCRIPT laparoscopic sacrocolpopexy for the treatment of post-hysterectomy vaginal vault

641

prolapse: LAS study. Int Urogynecol J. 2013; 24(3):377-84.

642

25. Yeung PP Jr, Bolden CR, Westreich D, Sobolewski C, Patient preferences of

643

cosmesis for abdominal incisions in gynecologic surgery. J Minim Invasive Gynecol.

644

2013; 20(1):79-84.

645

26. Kho RM. Comparison of robotic-assisted laparoscopy versus conventional

646

laparoscopy on skill acquisition and performance. Clin Obstet Gynecol. 2011;

647

54(3):376-81.

648

27. Khan A, Alperin M, Wu N, Clemens JQ, Dubina E, Pashos CL, Anger JT.

649

Comparative outcomes of open versus laparoscopic sacrocolpopexy among

650

medicare beneficiaries. Int Urogynecol J. 2013; 24(11):1883-91.

651

28. Belsante M, Murray S, Dillon B, Zimmern P. Mid term outcome of robotic mesh

652

sacrocolpopexy. Can J Urol. 2013 Feb; 20(1):6656-61.

653

29. Geller EJ, Parnell BA, and Dunivan GC. Robotic Vs Abdominal Sacrocolpopexy:

654

44-Month Pelvic Floor Outcomes. Urology 79: 532–536, 2012.

655

30. Siddiqui NY, Geller EJ, Visco AG. Symptomatic and anatomic 1-year outcomes

656

after robotic and abdominal sacrocolpopexy. Am J Obstet Gynecol. 2012;

657

206(5):435.e1-5.

658

31. Paraiso MF, Jelovsek JE, Frick A, et al. Laparoscopic compared with robotic

659

sacrocolpopexy for vaginal prolapse: a randomized controlled trial. Obstet Gynecol

660

2011; 118(5):1005Y1013.

AC C

EP

TE D

M AN U

SC

RI PT

640

30

ACCEPTED MANUSCRIPT 32. Elliott CS, Hsieh MH, Sokol ER, Comiter CV, Payne CK, Chen B. Robot-assisted

662

versus open sacrocolpopexy: a cost-minimization analysis. J Urol. 2012; 187(2):638-

663

43.

664

33. Diwadkar GB, Barber MD, Feiner B, Maher C, Jelovsek JE. Complication and

665

reoperation rates after apical vaginal prolapse surgical repair: a systematic review.

666

Obstet Gynecol. 2009; 113(2 Pt 1):367-73.]

667

34. Whitehead WE, Bradley CS, Brown MB, Brubaker L, Gutman RE, Varner

668

RE, Visco AG, Weber AM, Zyczynski H; Gastrointestinal complications

669

following abdominal sacrocolpopexy for advanced pelvic organ prolapse. Am J

670

Obstet Gynecol. 2007 Jul; 197(1):78.e1-7.

671

35. Warner WB, Vora S, Alonge A, Welgoss JA, Hurtado EA, von Pechmann WS.

672

Intraoperative and postoperative gastrointestinal complications associated with

673

laparoscopic sacrocolpopexy. Female Pelvic Med Reconstr Surg. 2012; 18(6):321-4.

674

36. Jia X, Glazener C, Mowatt G, Jenkinson D, Fraser C, Bain C, Burr J. Systematic

675

review of the efficacy and safety of using mesh in surgery for uterine or vaginal vault

676

prolapse. Int Urogynecol J. 2010; 21(11):1413-31.

677

37. Visco AG, Weidner AC, Barber MD, Myers ER, Cundiff GW, Bump RC, Addison

678

WA. Vaginal mesh erosion after abdominal sacral colpopexy. Am J Obstet Gynecol.

679

2001;184(3):297-302.

680

38. Downing KT, Vertebral osteomyelitis and epidural abscess after laparoscopic

681

uterus-preserving cervicosacropexy, J Minim Invasive Gynecol, 2008; 15(3):370-2

AC C

EP

TE D

M AN U

SC

RI PT

661

31

ACCEPTED MANUSCRIPT 39. Weidner AC, Cundiff GW, Harris RL, Addison WA, Sacral osteomyelitis: an

683

unusual complication of abdominal sacral colpopexy, Obstet Gynecol. 1997; 90(4 Pt

684

2):689-91

685

40. Muffly TM, Diwadkar GB, Paraiso MF. Lumbosacral osteomyelitis after robot-

686

assisted total laparoscopic hysterectomy and sacral colpopexy. nt Urogynecol J.

687

2010; 21(12):1569-71.

688

41. Shveiky D, Aseff JN, Iglesia CB. Brachial plexus injury after laparoscopic and

689

robotic surgery. J Minim Invasive Gynecol. 2010;17(4):414-20.

SC

M AN U

690

RI PT

682

42. ACOG Committee Opinion. Supracervical hysterectomy. Number 388 Novemvber 2007

692

43. El-Mowafi D, Madkour W, Lall C, Wenger JM. Laparoscopic supracervical

693

hysterectomy versus laparoscopic-assisted vaginal hysterectomy. J Am Assoc

694

Gynecol Laparosc 2004; 11:175–80.

695

44. Chen L, Ashton-Miller JA, Hsu Y, DeLancey JO. Interaction among apical

696

support, levator ani impairment, and anterior vaginal wall prolapse. Obstet Gynecol.

697

2006 Aug;108(2):324-32.

698

45. Cundiff GW, Varner E, Visco AG, Zyczynski HM, Nager CW, Norton PA, Schaffer

699

J, Brown MB, Brubaker L; Pelvic Floor Disorders Network. Risk factors for

700

mesh/suture erosion following sacral colpopexy. Am J Obstet Gynecol. 2008;

701

199(6):688.e1-5

AC C

EP

TE D

691

32

ACCEPTED MANUSCRIPT 46. Warner WB, Vora S, Hurtado EA, Welgoss JA, Horbach NS, von Pechmann WS.

703

Effect of operative technique on mesh exposure in laparoscopic sacrocolpopexy.

704

Female Pelvic Med Reconstr Surg. 2012; 18(2):113-7

705

47. Tan Kim J, Menefee SA, Luber KM, Nager CW, Lukacz ES. Prevalence and risk

706

factors for mesh erosion after laparoscopic-assisted sacrocolpopexy. Int Urogynecol

707

J. 2011; 22(2): 205–212.

708

48. Tate SB, Blackwell L, Lorenz DJ, Steptoe MM, Culligan PJ. Randomized trial of

709

fascia lata and polypropylene mesh for abdominal sacrocolpopexy: 5-year follow-up

710

Int Urogynecol J. 2011; 22(2):137-43.

711

49. Culligan PJ, Salamon C, Priestley JL, Shariati A. Porcine dermis compared with

712

polypropylene mesh for laparoscopic sacrocolpopexy: a randomized controlled trial.

713

Obstet Gynecol. 2013; 121(1):143-51

714

50. Quiroz LH, Gutman RE, Shippey S, Cundiff GW, Sanses T, Blomquist JL,

715

Handa VL. Abdominal sacrocolpopexy: anatomic outcomes and complications with

716

Pelvicol, autologous and synthetic graft materials. Am J Obstet Gynecol. 2008;

717

198(5):557.e1-5.

718

51. Salamon CG, Lewis C, Priestley J, Gurshumov E, Culligan PJ. Prospective study

719

of an ultra-lightweight polypropylene Y mesh for robotic sacrocolpopexy. Int

720

Urogynecol J. 2013 Jan 8. [Epub ahead of print]

721

52. Shepherd JP, Feola, AJ, Abramowitch, SD, Moalli, PA, Uniaxial Biomechanical

722

Properties of 7 Different Vaginally Implanted Meshes for Pelvic Organ Prolapse, Int

723

Urogynecol J. 2012 May ; 23(5): 613–620

AC C

EP

TE D

M AN U

SC

RI PT

702

33

ACCEPTED MANUSCRIPT 53. Shepherd JP, Higdon HL 3rd, Stanford EJ, Mattox TF. Effect of suture selection

725

on the rate of suture or mesh erosion and surgery failure in abdominal

726

sacrocolpopexy. Female Pelvic Med Reconstr Surg. 2010; 16(4):229-33.

727

54. Mattox TF, Stanford EJ, Varner E. Infected abdominal sacrocolpopexies:

728

diagnosis and treatment. Int Urogynecol J Pelvic Floor Dysfunct. 2004t ;15(5):319-

729

23.

730

55. Shah HN, Nayyar R, Rajamahanty S, Hemal AK. Prospective evaluation of

731

unidirectional barbed suture for various indications in surgeon-controlled robotic

732

reconstructive urologic surgery: Wake Forest University experience. Int Urol Nephrol.

733

2012 Jun;44(3):775-85.

734

56. Cundiff GW, Harris RL, Coates K, Low VH, Bump RC, Addison WA. Abdominal

735

sacral colpoperineopexy: a new approach for correction of posterior compartment

736

defects and perineal descent associated with vaginal vault prolapse. Am J Obstet

737

Gynecol. 1997; 177(6):1345-53.

738

57. Grimes CL, Quiroz LH, Gutman RE, Shippey S, Cundiff GW, Handa VL. Long-

739

term impact of abdominal sacral colpoperineopexy on symptoms of obstructed

740

defecation. Female Pelvic Med Reconstr Surg. 2010 ;16(4):234-7

741

58. Ramanah, Ballester M, Chereau E, Bui C, Rouzier R, Daraï E. Anorectal

742

symptoms before and after laparoscopic sacrocolpoperineopexy for pelvic organ

743

prolapse. Int Urogynecol J. 2012 ;23(6):779-83.

AC C

EP

TE D

M AN U

SC

RI PT

724

34

ACCEPTED MANUSCRIPT 59. Visco AG, Weidner AC, Barber MD, Myers ER, Cundiff GW, Bump RC, Addison

745

WA. Vaginal mesh erosion after abdominal sacral colpopexy. Am J Obstet Gynecol.

746

2001; 184(3):297-302.

747

60. Rooney K, Kenton K, Mueller ER, FitzGerald MP, Brubaker L, Advanced anterior

748

vaginal wall prolapse is highly correlated with apical prolapse, Am J Obstet Gynecol

749

2006; 125:1837-40.

750

61. Shippey S, Gutman RE, Quiroz LH, Handa VL. Contemporary approaches to

751

cystocele repair: a survey of AUGS members. J Reprod Med. 2008; 53(11):832-6

752

62. Shippey SH, Quiroz LH, Sanses TV, Knoepp LR, Cundiff GW, Handa VL.

753

Anatomic outcomes of abdominal sacrocolpopexy with or without paravaginal repair.

754

Urogynecol J. 2010; 21(3):279-83.

755

63. Gilleran JP, Zimmern P. Abdominal mesh sacrocolpopexy for recurrent triple-

756

compartment pelvic organ prolapse. BJU Int. 2009; 103(8):1090-4.

757

64. Guiahi M, Kenton K, Brubaker L. Sacrocolpopexy without concomitant posterior

758

repair improves posterior compartment defects. Int Urogynecol J Pelvic Floor

759

Dysfunct. 2008; 19(9):1267-70.

760

65. White AB, Carrick KS, Corton MM, McIntire DD, Word RA, Rahn DD, Wai CY.

761

Optimal location and orientation of suture placement in abdominal sacrocolpopexy.

762

Obstet Gynecol. 2009; 113(5):1098-103

AC C

EP

TE D

M AN U

SC

RI PT

744

35

ACCEPTED MANUSCRIPT 66. Balgobin S, Good MM, Dillon SJ, Corton MM. Lowest colpopexy sacral fixation

764

point alters vaginal axis and cul-de-sac depth. Am J Obstet Gynecol, 2013;

765

208(6);488.e1-6

766

67. Abernethy M, Vasquez E, Kenton K, Brubaker L, Mueller E. Where do we place

767

the sacrocolpopexy stitch? A magnetic resonance imaging investigation. Female

768

Pelvic Med Reconstr Surg. 2013; 19(1):31-3

769

68. Good MM, Abele TA, Balgobin S, Schaffer JI, Slocum P, McIntire D, Corton MM.

770

Preventing L5-s1 discitis associated with sacrocolpopexy. Obstet Gynecol. 2013;

771

121(2 Pt 1):285-90

772

69. Shippey S, Sutter E, Belkoff SM, Gutman R, Chen CC. Sacral mesh pullout

773

strength based on suture location for sacrocolpopexy. Gynecol Obstet

774

Invest.2012;74(2):116-9

775

70. Withagen MI, Vierhout ME, Mannaerts GH, van der Weiden RM. Laparoscopic

776

sacrocolpopexy with bone anchor fixation: short-term anatomic and functional

777

results. Int Urogynecol J. 2012; 23(4):481-6

778

71. Dalwai R, Menon KV, Kumar RJ. Pyogenic diskitis of the L5-S1 disk space

779

following inadvertent placement of a sacrocolpopexy screw. Int J Gynaecol Obstet.

780

2010; 111(3):268-9.

781

72. Vulliamy P, Berner AM, Farooq MS, Srilekha A. Near-fatal small bowel ischaemia

782

secondary to sacrocolpopexy mesh. BMJ Case Rep. 2013

AC C

EP

TE D

M AN U

SC

RI PT

763

36

ACCEPTED MANUSCRIPT 73. Elneil S, Cutner AS, Remy M, Leather AT, Toozs-Hobson P, Wise B. Abdominal

784

sacrocolpopexy for vault prolapse without burial of mesh: a case series. BJOG 2005;

785

112(4):486-9.

786

74. Rachaneni S, Latthe P. Role of perioperative low dose vaginal oestrogens in

787

improving the outcomes of pelvic organ prolapse surgery. Med Hypotheses. 2013

788

Sep 19. pii: S0306-9877(13)00457-X. doi: 10.1016/j.mehy.2013.09.019. [Epub

789

ahead of print]

790

75. Higgins EW, Rao A, Baumann SS, James RL, Kuehl TJ, Muir TW, Pierce LM.

791

Effect of estrogen replacement on the histologic response to polypropylene mesh

792

implanted in the rabbit vagina model. Am J Obstet Gynecol. 2009; 201(5):505.e1-9.

793

76. Vaccaro CM, Mutema GK, Fellner AN, Crisp CC, Estanol MV, Kleeman SD,

794

Pauls RN. Histological and cytological effects of vaginal estrogen in women with

795

pelvic organ prolapse: a randomized controlled trial. Female Pelv Med & Reconst

796

Surg 2013; 19(1): 34-39

797

77. de Tayrac R, Sentilhes L. Complications of pelvic organ prolapse surgery and

798

methods of prevention. Int Urogynecol J. 2013; 24(11):1859-72.

800

801

802

SC

M AN U

TE D

EP

AC C

799

RI PT

783

37

ACCEPTED MANUSCRIPT

AC C

EP

TE D

M AN U

SC

RI PT

803

ACCEPTED MANUSCRIPT

Maher et al. 2011 (16) Tan Kim et al.

women

follow up

rate

12 months

93% subjective 98% objective

24 months

Objective: 77% (LSC) 43% (vaginal mesh)

Retrospective 101: cohort 46 lap. Supracervical hysterectomy + sacrocolpopexy 55 LSC RCT 53 LSC 55 vaginal mesh

Retrospective 188 laparoscopic cohort or robotic sacrocolpopexy

See complications

See complications

Functional GI complications 1% (1 ileus, 3 SBO) Prolonged nausea/emesis 0.8% Bowel injury 1.3% (3 small bowel injuries, 2 rectal injuries)

Primary outcome GI complications

See complications

Mesh exposure rate Primary outcome 2.8% - higher rate mesh exposure associated with total (vs supracervical) hysterectomy, and with laparoscopic (vs vaginal) mesh suturing

AC C

2012 (26)

Retrospective 390 cohort

Warner et al. 2012 (37)

Retrospective 390 cohort

Recurrence only in anterior compartment (6%)

Primary outcome risk factors for mesh erosion

EP

Warner et al.

Remarks

Total 10% rate of mesh erosion Rate significantly higher in TLH vs supracervical hysterectomy or posthysterectomy

TE D

2011 (38)

Complications

RI PT

2008 (7)

Length of Outcome / Cure

SC

Sarlos et al.

Number of

M AN U

Author, year Design

ACCEPTED MANUSCRIPT

al.

Prospective cohort

90 LSC

30 months

Prospective cohort

6 months 49 women: 45 LSC 4 lap sacrohysteropexy

RCT

115: 57 porcine dermis 58 polypropylene mesh

Primary outcome anorectal symptoms

Culligan et al. 2013 (40)

Freeman RM Multi center RCT et al. 2013

98% objective (apical compartment) 79% subjective (apical compartment)

1 patient (2%) mesh exposure 1 patient (2%) small bowel injury

TE D

2012 (55)

12 months

EP

al.

AC C

Withagen et

M AN U

SC

2012 (46)

Post-op worsened CRADI (colorectalanal distress inventory) (p 0.02), no change in CRAIQ (colorectalanal impact questionnaire) (p 0.37)

RI PT

Ramanah et

Suture extrusion rate 3.6% - higher rate associated with laparoscopic (vs vaginal) mesh suturing

12 months

Porcine dermis: 80.7% objective, 84.2% subjective Polypropylene mesh: 86.2% objective, 89.7% subjective Subjective cure 90% ASC 80% LSC (NS)

(21) Table 1: Summary of studies on laparoscopic sacrocolpopexy outcome

Study examining efficacy of LSC with bone anchor fixation

Non statistically significant difference between groups

Less blood loss and shorter hospital stay in LSC

RCT comparing ASC and LSC

ACCEPTED MANUSCRIPT

Di Marco DS

Design

Number of

Length of

women

follow up

Cure rate

Complications

Retrospective 5 cohort

4 months

No recurrence

Retrospective 30 cohort

24 months

100% subjective

Retrospective 12 cohort

6 months

100% objective mean POP-Q Bp point +1.3  -2.65 C point +2.1  -8.28

Retrospective 178 women: cohort 73 RSC 105 ASC

6 weeks

Retrospective 54 women: cohort 17 RSC 37 vaginal mesh colpopexy RCT 78 women: 38 LSC 40 RSC

12 months

Retrospective 51 women: cohort 23 RSC 28 ASC

et al. 2004

Elliott DS et al.

Shveiky D et al. 2010 (14)

Paraiso MF et al. 2011 (23) Geller EJ et al.

RSC – higher incidence of post-operative fever

Comparing ASC to RSC

Objective cure RSC: 94.1% Vaginal mesh: 70.2%

Similar complication rate

Comparing RSC to vaginal mesh colpopexy

12 months

Similar objective cure rates

RSC – higher post-op pain and use of NSAIDs

44 months

Similar objective improvement

RSC: mesh erosion 8% ASC: mesh erosion 7%

EP

2008 (11)

RSC – improved POP-Q C-point, less blood loss

AC C

Geller EJ et al.

TE D

et al. 2007 (8)

M AN U

2006 (9)

Daneshgari F

1 recurrent grade 3 rectocele 1 recurrent vaginal vault prolapse 2 mesh erosion

SC

(10)

Remarks

RI PT

Author, year

Comparing long term outcome of RSC to ASC

ACCEPTED MANUSCRIPT

2012 (20)

al. 2012 (12) Belsante M et

Retrospective 88 women: cohort 65 RSC 23 LSC

3 months

Retrospective 35 RSC cohort

28 months

Objective improvement: POP-Q C point mean -1.1  -9.7 Subjective improvement (p

Sacrocolpopexy for treatment of vaginal apical prolapse: evidence-based surgery.

Pelvic organ prolapse is a common condition that negatively affects womens' quality of life. Sacrocolpopexy is an abdominal procedure designed to trea...
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