ORIGINAL ARTICLE

Robotic Sacrocolpopexy for the Management of Pelvic Organ Prolapse: A Review of Midterm Surgical and Quality of Life Outcomes Paholo G. Barboglio, MD, MPH,* Andrew J.W. Toler, MS,Þ and Veronica Triaca, MDþ

Introduction: Transabdominal sacrocolpopexy is a definitive treatment option for vaginal vault prolapse with durable success rates. The aim of our study was to review subjective and objective outcomes including complications after robotic assisted laparoscopic sacrocolpopexy for the repair of symptomatic pelvic organ prolapse. Methods: Single-site retrospective cohort study of women undergoing robotic assisted laparoscopic sacrocolpopexy with and without concomitant robotic assisted supracervical hysterectomy was performed. Pelvic Floor Distress Inventory-20 and Pelvic Floor Impact Questionnaire-7 questionnaires were used preoperatively and postoperatively to evaluate patient subjective data, respectively. We established a strict improvement of greater than 70% on questionnaire’s total score to determine clinical improvement. Results: Complications were assessed at 6 months and 127 women were included in our review. Mesh extrusion occurred in 3 (2.4%) patients. Other complications reported were bowel injury (2.4%), readmission rate (2.4%), wound infection (1.6%), and postoperative hernia at port site (1.6%). Objective and subjective outcomes were assessed at 1 year in 92 women. Although there was no recurrent apical prolapse at 1 year, anterior prolapse was present in 7 patients. Clinical improvement was present in 72% by Pelvic Floor Impact Questionnaire-7 and in 68% by Pelvic Floor Distress Inventory-20. Predictors of poor clinical outcomes were lysis of adhesions (OR, 5.83; 95% confidence interval [CI], 1.2Y27.4; P = 0.026), urethrolysis (OR, 11.91; 95% CI, 1.2Y117.9; P = 0.034), current smoking (OR, 7.9; 95% CI, 1.1Y58.7; P = 0.042), and older age (OR, 1.1; 95% CI, 1.0Y1.18; P = 0.044). Conclusions: Robotic assisted laparoscopic sacrocolpopexy represents a safe and effective surgical therapy to manage symptomatic apical pelvic organ prolapse. Serious complication rates are low but not rare when assessing short-term outcomes. Key Words: sacrocolpopexy, pelvic organ prolapse, apical prolapse, mesh extrusion, robotic surgery (Female Pelvic Med Reconstr Surg 2014;20: 38Y43)

P

elvic organ prolapse (POP) is a highly prevalent anatomic disorder with functional implications. It has been estimated that approximately 3% of women will have symptomatic prolapse in their lifetime.1 This has translated into 200,000 prolapse surgical repairs performed in 1 year in the United States alone.2 Apical vaginal prolapse is defined as the descent of the vaginal cuff or cervix and is frequently associated with prolapse of the anterior vaginal compartment. Surgical repair of these From the *Department of Surgery, Division of Urology, Dartmouth-Hitchcock Medical Center, Lebanon; †The Dartmouth Institute, Hanover; and ‡Concord Urology, Concord, NH. Reprints: Veronica Triaca, MD, Concord Urology, 246 Pleasant St, Memorial Building, Suite G2, Concord, NH 03301. E-mail: [email protected]. The authors have declared they have no conflicts of interest. Copyright * 2013 by Lippincott Williams & Wilkins DOI: 10.1097/SPV.0000000000000047

38

www.fpmrs.net

defects is performed by augmented or nonaugmented transvaginal suspension approaches, or with abdominal procedures including sacral colpopexy, cervicopexy, or hysteropexy. The selection of surgical modality, either vaginal or abdominal, as well as the type of abdominal approach, such as open, laparoscopic, or robotic, is determined by surgeon preference and expertise. Women with advanced age and other comorbidities may often benefit from obliterative procedures. However, if a patient desires a reconstructive procedure, addressing the apex is best accomplished by abdominal suspension procedures such as the sacrocolpopexy.3 Abdominal sacrocolpopexy is associated with a 3% risk of mesh extrusion for all types of synthetic mesh, in addition to a small risk for blood transfusion, enterotomy, cystotomy, ileus, thromboembolic event, and incisional wound problems.4 The laparoscopic approach offers similar outcomes and complication rates to open surgery with improvements in postoperative pain, blood loss, and hospital stay length, often at the expense of longer operative time.5 Data on robotic assisted laparoscopic sacrocolpopexy (RALS) to assess objective and subjective outcomes as well as risks and complications are limited. The aim of our study was to review subjective and objective outcomes including complications after RALS for the repair of symptomatic POP.

METHODS Institutional review board approval was obtained in our institution to perform a retrospective analysis of all women undergoing RALS for symptomatic apical POP from May 2010 to August 2012. Demographic variables, preoperative and postoperative questionnaire data collection, initial history, and physical examination, as well as diagnosis and follow-up were performed by single surgeon (V.T.). Although published literature suggests that mesh extrusion occurs during the first 3 months,6 we extended this to a 6-month period to evaluate this better. Mesh extrusion was defined as any palpable or visible mesh noted at any point during the first 6 months. Patients underwent pelvic examination at week 2, and at 3, 6, and 12 months, respectively. Additionally, the incidence of major complications including bowel injury, wound infection, and incisional hernia at port site was analyzed. Patients who were rehospitalized within the first 30 postoperative days, as well as incidence of postoperative ileus and voiding dysfunction were investigated and reported. Outcomes also included objective data analysis attained by Baden-Walker (BW) preoperative POP grading and subjective data retrieved from self-reported quality of life (QOL) validated questionnaires administered preoperatively and postoperatively. The BW grading system consists of 4 grades: grade 0, no prolapse; grade 1, halfway to hymen; grade 2, to hymen; grade 3, halfway past hymen; and grade 4, maximum descent.7 The Pelvic Floor Impact Questionnaire (PFIQ-7) and the Pelvic Floor Distress Inventory (PFDI-20)8 were selected because

Female Pelvic Medicine & Reconstructive Surgery

&

Volume 20, Number 1, January/February 2014

Copyright © 2013 Wolters Kluwer Health | Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.

Female Pelvic Medicine & Reconstructive Surgery

&

Volume 20, Number 1, January/February 2014

they represent a reliable and valid tool to assess QOL in women with pelvic floor disorder.9 These are evaluated by their total score (TS) range (0Y300) and their 3 respective subscales. The PFIQ-7 contains a urinary (UIQ), a colorectal (CRAIQ), and a prolapse (POPIQ) rate scale; the PFDI-20 is comprised of 3 surveys assessing prolapse (POPDI), colorectal (CRADI), and the short version of the urinary distress inventory (UDI-6).10 Each of these subscales has a score (0Y100), the highest number represents more severe symptoms in the main questionnaires and each of its subscales. To assess the subjective outcomes, we calculated the improvement rate at 1 year. Clinical significance was determined in those women who improved greater than 70% in their questionnaire TSs when compared to preoperative scores and this was used for our power analysis. Different cutoffs have been used; nonetheless, we selected a strict improvement threshold of 70% or more to assess QOL data. Other authors have previously used this cutoff when assessing validated questionnaires.11 Those women with less than 70% improvement in both PFDI-20 and PFIQ-7 at 1-year follow-up were determined as having negative outcomes. Additionally, the AUA index questionnaire was used to assess a QOL value specifically, ‘‘How would you feel if you had to live with your current condition for the rest of your life.’’ Higher scores represent worse QOL (range, 0Y6). When assessing objective data by B-W grading, clinical improvement (clinical significance) was determined if there was no apical prolapse recurrence (grade 0/1). Questionnaires were completed in the waiting room before the history and physical examination and without the influence of any health care provider. Conservative and alternative management, as well as Food and Drug Administration mesh warnings were discussed and offered to all patients. Women undergoing simultaneous robotic supracervical hysterectomy were also evaluated by a gynecologist. Distal urethral polypropylene sling12 was placed in all patients unless they already had a previous anti-incontinence procedure to address occult as well as symptomatic stress urinary incontinence. The use of prophylactic sling is supported by the Pelvic Floor Disorders Network randomized control trial results.13 Robotic sacrocolpopexy was performed using Da Vinci Si (Intuitive, Sunnyvale, Calif ) robot by single fellowship-trained female urologic surgeon. Concomitant posterior compartment defect repairs were performed if present and symptomatic preoperatively. Large anterior defects were not separately addressed. The robotic surgical technique was first described by Di Marco group14 in 2004. This procedure was performed using 4 robotic arms and having an assistant at right-sided port. After pneumoperitoneum is gained, the ports are placed and the robot is docked on the left side, in a parallel orientation to the bed. A vaginal manipulator system is placed in the vagina. The procedure is started by retracting the descending colon toward the left side laterally to expose the sacral promontory. The transverse longitudinal ligament of the sacrum is exposed by opening the peritoneum overlying it. A retroperitoneal tunnel is developed from the sacrum promontory to the posterior vaginal wall. The peritoneal edge is then identified at the vaginal cuff or cervical junction. This is then dissected anteriorly and posteriorly. A premade large pore polypropylene Y-mesh (IntePro; AMS, Minnetonka, Minn) is secured to the anterior and posterior vaginal cuff wall with approximately 5 interrupted sutures, respectively, using ePTFE (Gore-Tex W.L. Gore & Associates, Inc, Newark, Del) to aid with this step. At this point, the vaginal laxity to the apex is reduced and the tail of the mesh is secured to the sacrum. Vaginal examination is performed to assess suspension. Polyester sutures (2Y3) are used to secure the apex of the mesh to the sacrum, at the transverse longitudinal * 2013 Lippincott Williams & Wilkins

RALS for the Management of POP

ligament. Adequate tension is verified by the surgeon’s assistant. The mesh is retroperitonealized using a polyglactin 910 running suture to close the peritoneum. Patients were subsequently evaluated postoperatively at 2 weeks; and then at 3, 6, and 12 months; and annually after that. Data collection was performed in Microsoft Excel (Microsoft Corporation, Redmond, Wash). Data analysis and graphing were performed in STATA 11.2 (StataCorp, College Station, Tex). Continuous data were assessed for normal distributions using histograms and pairwise correlation. Categorical data were assessed versus the primary outcome (failure to attain 70% improvement at 912 months) using Pearson W2 test. A stepwise logistic regression model was built from significant (P G 0.05) univariate relationships, assessed for clinical plausibility and a final multivariate model was constructed for the most explanatory variables. A sample size of 32 women was calculated (> = 0.01; A = 0.95) to look for a 70% difference using STATA 11.2.

RESULTS During the study period, 131 women who underwent RALS were identified. Outcomes were assessed in 127 patients with complete 6-month follow-up period. Patient mean (SD) age was 59 (11.34) years, mean (SD) body mass index (BMI) was 28.68 (5.29) kg/m2, median follow-up was 12 months (interquartile range, 6Y13), and other demographics are illustrated in Table 1. Ninety-two women have complete objective and subjective data at 1-year follow-up. No patient had apical prolapse recurrence at 12 months and 92% of the patients had POP stage I or 0. However, there were 7 (8%) patients who had anterior compartment stage II prolapse. Only 2 of these women continued with prolapse symptoms and underwent anterior transvaginal colporrhaphy within the first 6 months and no defect larger than stage I in the apex. These patients had subsequent objective and subjective outcome improvement at 1-year follow-up. Subjective data (Table 2) revealed clinical improvement (970%) on PFIQ-7 TS in 72% of patients. When assessing the bladder, bowel, and pelvic subscales, there was a clinical improvement in 76%, 83%, and 86% of patients, respectively. Clinical improvement (970%) on PFDI-20 TS was attained in 68% women. Individual subscale analysis of prolapse (POPDI), colorectal (CRADI), and the short version of the urinary distress inventory (UDI-6) revealed clinical improvement in 76%, 57%, and 66%, respectively. There was no significant difference in preoperative questionnaires between the 2 groups. All postoperative questionnaires were significantly improved (P G 0.01) when compared to baseline in those women with more than 70% improvement, as expected. Statistical significance was also documented in those women who failed to improve (970%) in both questionnaires when compared to baseline. Although these women had less than 70% improvement, their scores were significantly upgraded (P G 0.01) in the PFI-Q7 and PFDI-20 questionnaires and subscales with the exception of the POPIQ (P = 0.037). Subanalysis was performed to assess those women with clinical improvement (970%) and evaluate those who failed to clinically improve according to both PFDI and PFIQ-7 questionnaire’s TSs. There were 15 patients who failed to improve in both questionnaires and 77 who clinically improved (970%) in either the PFDI-20 or PFIQ-7 questionnaire. Table 3 illustrates the demographics of these 2 groups. Operative and postoperative outcome variables are shown in Table 4. A logistic regression model analysis was performed as illustrated in the graph. Variables that were significantly different www.fpmrs.net

Copyright © 2013 Wolters Kluwer Health | Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.

39

Female Pelvic Medicine & Reconstructive Surgery

Barboglio et al

TABLE 1. Demographics History and Physical Age, mean (SD), y BMI, mean (SD), kg/m2 DM Menopause Oral estrogens Hysterectomy Hx Prolapse rep. Hx Current smoker OAB SUI MUI Use of pessary Parity P0 PI PII PIII 9PIII Physical examination UH

n = 127, n (%) 58.87 (11.34) 28.68 (5.29) 6 (5) 85 (67) 11 (9) 53 (42) 23 (18) 13 (10) 13 (10) 22 (17) 66 (52) 44 (35) 2 (2) 11 (9) 53 (42) 32 (25) 29 (23) 112 (88)

Objective Data by Physical Examination (BW) Grading System POP grade 0 1 2 3 4 Anterior, % 0.00 4.72 13.39 55.12 26.77 Apical, % 0.00 3.15 44.88 40.16 11.81 Posterior, % 2.36 16.54 48.03 26.77 6.30 DM indicates diabetes mellitus; MUI, mixed incontinence; OAB, overactive bladder; SUI, stress urinary incontinence; UH, urethral hypermobility.

or were close to be statistical significance were incorporated in logistic regression. Predictors of poor clinical outcomes were lysis of adhesions 40% versus 10% (OR [SD], 5.83 [4.6];

&

Volume 20, Number 1, January/February 2014

95% confidence interval [CI], 1.2Y27.4; P = 0.026); urethrolysis 13% versus 3% (OR [SD], 11.91 [13.9]; 95% CI, 1.2Y117.9; P = 0.034); current smoking 20% versus 6% (OR [SD], 7.9 [8.1]; 95% CI, 1.1Y58.7; P = 0.042); and 64 versus 58 years old (OR [SD], 1.1 [0.04]; 95% CI, 1.0Y1.18; P = 0.044). Table 5 shows the analysis of anatomical (objective) outcomes. Ninety-two patients had completed follow-up at 12 months. Eighty-six of these women had complete apical prolapse resolution (grade 0) and 6 (6.5%) patients had apical POP grade 1. According to our definition, all women had objective improvement. Nonetheless, there were 6 women with anterior POP grade 2 and 1 woman with grade 3. As illustrated in Table 5, there was no association between objective and subjective outcomes. Mesh vaginal extrusion was found in 3 patients at the apex of the vagina. All women had less than 5 mm of mesh extrusion, which was removed in the office and responded to topical estrogens. Two patients have been followed up for 2 years and 1 woman was seen at 3 months after mesh removal and none of these have had recurrence. Mesh extrusion was not associated with a worse subjective (improvement of 970%), or objective outcomes. There were no differences in patient demographics, prolapse grade, concomitant hysterectomy, rectocele repair, operative time, or estimated blood loss. Immediate perioperative complications included 3 bowel injuries. These women had history of previous abdominal surgery and underwent lysis of adhesions and this was statistically higher (P G 0.001) when compared to those women without bowel injury. We found no other predictors or any suggesting trend when assessing patient’s demographics. Two injuries were recognized intraoperatively, one was a clean cut enterotomy that required a primary repair, and the other was suspicious for thermal bowel injury that required excision and primary anastomosis. Both repairs were performed by general surgery staff consulted intraoperatively. Both of these patients spent 2 days in the hospital and had no further complications. The third woman had an unrecognized enterotomy, bowel leak, and developed peritonitis. This was diagnosed on postoperative day 5 and patient underwent exploratory laparotomy and primary anastomosis. Patient was able to go back to her regular activities at 6 months and has had no further complications. Subjective

TABLE 2. Questionnaire Data Results at 1-y Follow-up s/p RAL-Sacrocolpopexy in Women With Symptomatic Apical Prolapse Questionnaire PFIQ-7

PFDI-20

40

www.fpmrs.net

Status

Score

Scale

Preoperative Preoperative Preoperative Preoperative Postoperative Postoperative Postoperative Postoperative Preoperative Preoperative Preoperative Preoperative Postoperative Postoperative Postoperative Postoperative

0Y100 0Y100 0Y100 0Y300 0Y100 0Y100 0Y100 0Y300 0Y100 0Y100 0Y100 0Y300 0Y100 0Y100 0Y100 0Y300

Bladder Bowel Pelvis TS Bladder Bowel Pelvis TS POPDI-6 CRADI-8 UDI-6 TS POPDI-6 CRADI-8 UDI-6 TS

Median 38.10 4.76 14.29 54.76 0.00 0.00 0.00 0.00 41.67 20.31 45.83 108.33 6.25 6.25 4.17 20.83

Interquartile 14Y57 0Y29 0Y48 27Y114 0Y9 0Y2 0Y0 0Y15 25Y63 13Y47 28Y63 75Y156 0Y13 0Y16 0Y17 8Y42

Improvement Q 70% (n = 92)

70 52 61 63

70 76 79 66

* 2013 Lippincott Williams & Wilkins

Copyright © 2013 Wolters Kluwer Health | Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.

Female Pelvic Medicine & Reconstructive Surgery

&

Volume 20, Number 1, January/February 2014

RALS for the Management of POP

TABLE 3. Preoperative Demographic Variables of Women Based on Clinical Improvement (Q70%) on Subjective Data at 1-y Follow-up Clinical Improvement Demographic Variables Age, mean (SD), y BMI, mean (SD), kg/m2 DM Menopause Oral estrogens RASCH Hx of prolapse repair Ever smoker Current smoker OAB SUI MUI PQ2 Hx of pessary usage Preoperative AUA- QOL, median (IQ) Urethral hypermobility Preoperative POP grade (B-W) Anterior POP G 9 2 Apical POP G 9 2 Posterior POP G 9 2

No Clinical Improvement

n = 77 57.8 (10.96) 28.8 (5.03)

n = 15

P

1 12 2 7 1 9 3 2 3 8 14 2

64.2 (10.47) 28.3 (5.25)

67

15

0.045 0.702 0.819 0.229 0.165 0.151 0.292 0.195 0.107 0.835 0.771 0.869 0.760 0.097 0.430 0.139

72 74 63

15 15 12

0.310 0.437 0.868

4 49 3 51 14 32 5 5 13 43 70 27 4 (3Y5)

4 (3Y5)

DM indicates diabetes mellitus; IQ, interquartile range (25%Y75%); MUI, mixed incontinence; OAB, overactive bladder; P, Parity; RASCH, robotic supracervical hysterectomy (concomitant surgery); SUI, stress urinary incontinence.

data were clinically significant (improvement of 970%) in their questionnaires with the exception of the woman with unrecognized injury who only had improved in the PFDI-20. Interestingly, despite having had these complications, patients

stated to be delighted or pleased in their last follow-up visit (score 0Y1) in their AUA QOL survey. Only 1 patient required blood product transfusion as recommended by hematology given factor Leiden V deficiency

TABLE 4. Operative Outcome Variables Based on Clinical Improvement (970%) on Subjective Data at 1-y Follow-up Clinical Improvement Operative Variables Op time, mean (SD) RASCH Lysis of adhesions MUS Rectocele rep. EBL, mean (SD) Hospital length, median (IQ) Complications Urinary retention Bowel injury Mesh extrusion Wound infection Hernia at port-site Further surgery Anterior repair Post repair Urethrolysis

No Clinical Improvement

n = 77 122.4 (47.06) 51 8 72 21 126.6 (95.5) 2 (2Y3)

P

n = 15 133.4 (44.65) 7 6 15 2 133.3 (117.51) 2 (2Y3)

0.407 0.157 0.007 0.310 0.266 0.809 0.680

5 2 1 1 2

2 0 1 0 0

0.371 0.528 0.192 0.657 0.528

2 2 2

0 1 2

0.328 0.413 0.093

IQ indicates interquartile range (25%Y75%); EBL, estimated blood loss.

* 2013 Lippincott Williams & Wilkins

www.fpmrs.net

Copyright © 2013 Wolters Kluwer Health | Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.

41

Female Pelvic Medicine & Reconstructive Surgery

Barboglio et al

&

Volume 20, Number 1, January/February 2014

TABLE 5. Postoperative Objective (BW) Data in Women With Clinical Improvement (Q70%) at 1-y Follow-up Clinical Improvement Preoperative grading Anterior-POP Apical-POP Post-POP Postoperative grading Ant-POP Apical-POP Post-POP

0 0 0 3 0 45 71 53

Preoperative vs postoperative Anterior Apical Posterior

1 5 3 11 1 25 6 15

2 9 34 41 2 6 0 9

3 41 31 20 3 1 0 0

P G0.001 G0.001 G0.001

that had an estimated blood loss of 100 mL and was discharged home on postoperative day 4; she had no complications. There were 3 readmissions within the first postoperative month. One patient had hyponatremia and required 2 hospitalization days before she was discharged home and had no further complications. Two other patients developed Clostridium difficile infection. These were nonconsecutive cases and 1 patient had already been infected in the past and she received a different prophylactic antibiotic. Both patients responded to medical treatments and had no further complications. Two patients developed postoperative ileus and required a longer hospitalization course (5 and 7 days) and had no further complications. Two patients developed a port site wound infection within the first 2 postoperative weeks and improved after appropriate incision and drainage. Postoperative port site (12 mm) hernia developed in 2 women within the first 4 months and underwent surgical hernia repair with general surgery. All these patients who developed wound infection and port site hernia had a BMI of 31, 36, 30, and 37 kg/m2, respectively. Short-term complications included voiding dysfunction and high residual volumes for the first 3 weeks in 10 patients who underwent distal urethral polypropylene sling. Four (3%) of these women required urethrolysis within the first month and the other women had resolution of their voiding dysfunction and a postvoid residual less than 50 mL with no further issues.

DISCUSSION Our study showed clinical improvement in more than two thirds of the patients. We believe that establishing a stricter threshold for improvement allowed us to identify those women whose clinical expectations were not met and analyzed variables to look for predictors. Despite the small sample size and the wide CIs, the logistic regression model suggests that lysis of adhesions is the strongest predictor of poor outcomes and other variables like older age, urethrolysis, and current smoking may be implicated as well. Objective cure rates based on anatomical evaluation of the vaginal apex were very high as previously described by Geller et al. Objective outcomes should comprise the complete description of all compartments15Y17 because there were 6 women with anterior POP grade 2 and 1 with grade 3. Unfortunately, given our limited cohort sample and the low frequency of poor anatomical outcomes, we were not able to find any association when assessing the effect of other POP compartments objective outcomes. A recent publication of Salamon et al evaluated 120

42

www.fpmrs.net

P

No Clinical Improvement 4 22 9 2 4 0 0 0

0 0 0 0 0 8 15 13

1 0 0 3 1 5 0 0

2 4 7 7 2 0 0 2

3 7 7 3 3 0 0 0

4 4 1 2 4 0 0 0

0.310 0.437 0.868 0.224 1.0 0.857

P G0.001 G0.001 G0.001

women undergoing RALS and determined anatomical success using POP-Q staging system. The study reported objective improvement (stage 0-I) in 89% of women and then assessed overall clinical improvement in 94%, accounting for subjective data from PFDI-20, POP-Q points less than 0, POP-Q point C less than 5, and no prolapse reoperation.16 More long-term (42-month median follow-up) outcome data were later published showing a recurrence rate of 9.6%with a satisfaction rate of 90%.17 Although these data may indicate that patient’s symptoms may well rely on patient’s postoperative POP (anatomical) status, only 2 of 7 women with persistent anterior POP in our study pursued a subsequent anterior repair. On the basis of our study findings, these patients with BW grade 2 and symptom’s improvement may not require further surgical repair. We recognize that BW grading system is neither endorsed by AUGS nor SUFU and the evaluation of low-grade POP is limited when compared to POP-Q examination. Although, approximately 80% of the women in our study had a baseline apical/anterior POP grade 3 to 4 which correlates somewhat better with POP-Q stage III/IV. A study by Louis-Sylvestre and Herry18 on RALS for POP stage III showed persistent POP in 6.6%, which is very similar to our 7.6% (7/92) when accounting for anterior compartment. All patients with persistent anterior POP at 1 year had a baseline anterior/apical POP grade 3 or 4. However, we found no association on POP grading system on either objective or subjective outcomes. This may be due to our limited statistical power given our sample size. The rate of mesh extrusion in our cohort is 2.36% at 6 months from RALS. These findings correlate with previously published data. Elliot et al19 published first experience on robotic sacrocolpopexy with a mesh extrusion incidence rate of 6.7% (2/30). These women had approximately 10 mm mesh exposure at the vaginal cuff, which was managed with outpatient surgical removal. However, in 2011, a study of Geller et al15 described good results by addressing 2 women with conservative management for a less than 3-mm extrusion at the apex. The study had an extrusion rate of 7.8% (2/30). Matthews et al prospective study results showed an overall mesh extrusion rate of 2.3%. Two women had mesh removed in the office, while a third required removal in the operating room.20 All these studies have a 12-month follow-up and mesh extrusion was diagnosed within the first 6 months in most of the cases. Other studies have found no mesh extrusion in a year * 2013 Lippincott Williams & Wilkins

Copyright © 2013 Wolters Kluwer Health | Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.

Female Pelvic Medicine & Reconstructive Surgery

&

Volume 20, Number 1, January/February 2014

follow-up.16,17 Although our study is not powered to infer any conclusions given the small rate of mesh extrusion, all women in our study improved with conservative measures after mesh (G5 mm) was removed in the office. Interestingly, subjective data showed clinical improvement in two thirds on PFIQ-7 and only 1 woman had clinical improvement on PFDI-20. These findings correlate with the fact that they all had objective improvement. The Pelvic Floor Disorders Network showed an increased risk for mesh and suture extrusion in women undergoing concomitant hysterectomy and those who were current smokers in patients undergoing open abdominal sacrocolpopexy.21 Osmundsen et al confirmed this finding in their robotic cohort showing an increased risk for those with previous total hysterectomy. Other complications reported were bowel injury (2%) of which one was unrecognized and required surgical exploration, a long hospitalization course. Other studies have also reported a similar rate of injuries.17,22 Multiple QOL-validated questionnaires have been used to evaluate prolapse subjective outcomes. Nonetheless, determining significance and the evaluation of improvement is a controversial subject that is not yet standardized. A meta-analysis on laparoscopic sacrocolpopexy showed an average patient satisfaction of 94.4% (range, 79%Y98%).5 Other limitations to our study include the single-site retrospective analysis and the relatively small sample. Possible bias may be influenced by the single surgeon’s physical examination evaluation to determine objective outcomes. A pelvic examination performed by a gynecologist in one of our comprehensive clinics may have helped to reduce this. We also acknowledge that 1-year follow-up data only represent a shortterm picture. Nonetheless, we believe that this is an adequate period to assess initial objective and subjective outcomes because the literature is still limited in this subject, and controversies surrounding the use of RAL for sacrocolpopexy are still unanswered. Another strength to our study is the description of objective and subjective outcomes as well as complications. We believe this should be the mainstay.

CONCLUSIONS Robotic assisted laparoscopic sacrocolpopexy represents a safe and effective surgical therapy to manage symptomatic POP. Serious complications are low but not rare. Objective outcomes at 1 year are excellent when assessing apical compartment and the frequency of persistent anterior POP is low. Surgical failure should be based on objective and subjective outcomes. We believe that a strict criteria of 70% improvement or higher on validated questionnaire could be adopted to standardize the analysis of future studies. Prospective analysis on patients with poor clinical improvement and/or severe complications will allow us to investigate predictors for RALS postoperative outcomes. REFERENCES 1. Nygaard I, Barber MD, Burgio KL, et al. Prevalence of symptomatic pelvic floor disorders in US women. JAMA 2008;300:1311Y1316. 2. Jones KA, Shepherd JP, Oliphant SS, et al. Trends in inpatient prolapse procedures in the United States, 1979Y2006. Am J Obstet Gynecol 2010;202:501.e1Y501.e7. 3. Jelovsek JE, Maher C, Barber MD. Pelvic organ prolapse. Lancet 2007;369:1027Y1038.

* 2013 Lippincott Williams & Wilkins

RALS for the Management of POP

4. Nygaard I, Bradley C, Brandt D, et al. Pelvic organ prolapse in older women: prevalence and risk factors. Obstet Gynecol 2004;104: 489Y497. 5. Ganatra AM, Rozet F, Sanchez-Salas R, et al. The current status of laparoscopic sacrocolpopexy: a review. Eur Urol 2009;55:1089Y1103. 6. Osmundsen BC, Clark A, Goldsmith C, et al. Mesh erosion in robotic sacrocolpopexy. Female Pelvic Med Reconstr Surg 2012;18:86Y88. 7. Baden WF, Walker TA, Lindsey JH. The vaginal profile. Tex Med 1968;64:56Y58. 8. Barber MD, Kuchibhatla MN, Pieper CF, et al. Psychometric evaluation of 2 comprehensive condition-specific quality of life instruments for women with pelvic floor disorders. Am J Obstet Gynecol 2001;185: 1388Y1395. 9. Barber MD, Walters MD, Bump RC. Short forms of two condition-specific quality-of-life questionnaires for women with pelvic floor disorders (PFDI-20 and PFIQ-7). Am J Obstet Gynecol 2005; 193:103Y113. 10. Shumaker SA, Wyman JF, Uebersax JS, et al. Health-related quality of life measures for women with urinary incontinence: the Incontinence Impact Questionnaire and the Urogenital Distress Inventory. Continence Program in Women (CPW) Research Group. Qual Life Res 1994;3:291Y306. 11. Nager CW, Brubaker L, Litman HJ, et al. A randomized trial of urodynamic testing before stress-incontinence surgery. N Engl J Med 2012;366:1987Y1997. 12. Rodriguez LV, Raz S. Prospective analysis of patients treated with a distal urethral polypropylene sling for symptoms of stress urinary incontinence: surgical outcome and satisfaction determined by patient driven questionnaires. J Urol 2003;170:63. 13. Wei JT, Nygaard I, Richter HE, et al. A midurethral sling to reduce incontinence after vaginal prolapse repair. N Engl J Med 2012;366: 2358Y2367. 14. Di Marco DS, Chow GK, Gettman MT, et al. Robotic-assisted laparoscopic sacrocolpopexy for treatment of vaginal vault prolapse. Urology 2004;63:373Y376. 15. Geller EJ, Parnell BA, Dunivan GC. Pelvic floor function before and after robotic sacrocolpopexy: one-year outcomes. J Minim Invasive Gynecol 2011;18:322Y327. 16. Salamon CG, Lewis C, Priestley J, et al. Prospective study of an ultra-lightweight polypropylene Y mesh for robotic sacrocolpopexy. Int Urogynecol J 2013;24:1371Y1375. 17. Germain A, Thibault F, Galifet M, et al. Long-term outcomes after totally robotic sacrocolpopexy for treatment of pelvic organ prolapse. Surg Endosc 2013;27:525Y529. 18. Louis-Sylvestre C, Herry M. Robotic-assisted laparoscopic sacrocolpopexy for stage III pelvic organ prolapse. Int Urogynecol J 2013;24:731Y733. 19. Elliott DS, Krambeck AE, Chow GK. Long-term results of robotic assisted laparoscopic sacrocolpopexy for the treatment of high grade vaginal vault prolapse. J Urol 2006;176:655Y659. 20. Matthews CA, Carroll A, Hill A, et al. Prospective evaluation of surgical outcomes of robot-assisted sacrocolpopexy and sacrocervicopexy for the management of apical pelvic support defects. South Med J 2012; 105:274Y278. 21. Cundiff GW, Varner E, Visco AG, et al. Risk factors for mesh/suture erosion following sacral colpopexy. Am J Obstet Gynecol 2008;199: 688.e1Y688.e5. 22. Paraiso MF, Walters MD, Rackley RR, et al. Laparoscopic and abdominal sacral colpopexies: a comparative cohort study. Am J Obstet Gynecol 2005;192:1752Y1758.

www.fpmrs.net

Copyright © 2013 Wolters Kluwer Health | Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.

43

Robotic sacrocolpopexy for the management of pelvic organ prolapse: a review of midterm surgical and quality of life outcomes.

Transabdominal sacrocolpopexy is a definitive treatment option for vaginal vault prolapse with durable success rates. The aim of our study was to revi...
288KB Sizes 0 Downloads 0 Views