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:
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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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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
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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.
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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.
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Art. No
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6.
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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
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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;
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100(4):875-9.
594
10.
595
laparoscopic sacrocolpopexy for the treatment of high grade vaginal vault prolapse. J
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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,
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2013;309(19):2016-2024
638 639
AC C
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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
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801
802
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799
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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