Objective
The purpose of this study was to compare symptomatic and anatomic outcomes 1 year after robotic vs abdominal sacrocolpopexy.
Study Design
Our retrospective cohort study compared women who underwent robotic sacrocolpopexy (RSC) with 1 surgeon to those who underwent abdominal sacrocolpopexy (ASC) as part of the Colpopexy and Urinary Reduction Efforts trial. Our primary outcome was a composite measure of vaginal bulge symptoms or repeat surgery for prolapse.
Results
We studied 447 women (125 with RSC and 322 with ASC). Baseline characteristics were similar. There were no significant differences in surgical failures 1 year after surgery based on our primary composite outcome (7/86 [8%] vs 12/304 [4%]; P = .16). When we considered anatomic failure, there were also no significant differences between RSC and ASC (4/70 [6%] vs 16/289 [6%]; P = .57).
Conclusion
One year after sacrocolpopexy, women who underwent RSC have similar symptomatic and anatomic success compared with those women who underwent ASC.
Abdominal sacrocolpopexy (ASC) is considered the gold-standard surgical repair for advanced pelvic organ prolapse. However, the open abdominal approach may be associated with increased perioperative morbidity compared with less invasive vaginal or laparoscopic approaches. Robotic-assisted laparoscopic sacrocolpopexy (RSC) has been used to accomplish the same procedure in a minimally invasive fashion and is being adopted rapidly in many centers. Similar short-term efficacy between RSC and ASC has been shown. However, medium- and long-term outcome data are lacking.
Our primary objective was to compare symptomatic and anatomic outcomes 1 year after RSC vs ASC. Our secondary objectives were to assess for differences in pelvic support based on Pelvic Organ Prolapse Quantification (POP-Q) examination, to assess for differences in quality of life based on validated questionnaires, and to assess long-term complications.
Materials and Methods
This was a retrospective cohort study in women who had undergone sacrocolpopexy for surgical treatment of stage II-IV pelvic organ prolapse. The study received institutional review board approval from the University of North Carolina–Chapel Hill (UNC) and Duke University Medical Center (Duke). Our 2 groups comprised (1) women who underwent RSC by 1 attending surgeon (A.G.V.) at UNC (March 2006–March 2007) and Duke (April 2007–April 2009) and (2) an historic cohort who underwent ASC as part of the Colpopexy and Urinary Reduction Efforts (CARE) trial between March 2002 and April 2007. The CARE trial was a multicenter randomized trial that was performed by the Pelvic Floor Disorders Network; the same attending surgeon (A.G.V.) was an investigator in this trial. RSC was performed with a lightweight, Y-shaped polypropylene mesh (American Medical Systems, Minnetonka, MN). ASC was performed with various synthetic meshes or biologic grafts, per the surgeon’s discretion. In the RSC group, antiincontinence procedures (ie, midurethral mesh slings) were performed based on symptoms and barrier reduction urodynamic testing. Conversely, women in the ASC group were assigned randomly to either a Burch urethropexy or no antiincontinence procedure.
At least 1 year after surgery, women who had undergone RSC were contacted to complete validated condition-specific quality-of-life questionnaires and to undergo a pelvic examination. Questionnaires included the Pelvic Floor Distress Inventory and Pelvic Floor Impact Questionnaire short forms (PFDI-20, PFIQ-7), and the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire short form (PISQ-12), for those who were sexually active. Examinations were performed by the attending surgeon or urogynecology fellow. During the pelvic examination, POP-Q scores were collected, and the vagina was inspected for mesh erosion.
Women who underwent ASC as part of the CARE trial underwent a standard study visit 12 months after surgery. During this visit, they completed the full-length PFDI and PFIQ ; sexually active women completed the full-length PISQ. Women also underwent pelvic examination with POP-Q scores and assessment for mesh erosion.
Our primary outcome was a composite measure that was defined as either bothersome vaginal bulge symptoms or repeat surgery for prolapse ( Figure ). Secondary outcomes included anatomic failure 1 year after sacrocolpopexy (defined as vaginal apex descending more than one-third into the vaginal canal or any prolapse beyond the hymen). These outcomes were chosen to be consistent with other composite outcomes from surgical trials that assessed prolapse repair. In addition, median postoperative POP-Q points were compared between groups. Finally, questionnaire responses were compared with assessment of overall impact on pelvic floor function and quality of life.
Because antiincontinence procedures were performed with some variability across our study population (based on barrier reduction urodynamic testing in the RSC group and randomization assignment in the ASC group), we limited our analysis to the prolapse subscales of pelvic floor questionnaires. The Pelvic Organ Prolapse Distress Inventory (POPDI-6) and Pelvic Organ Prolapse Impact Questionnaire (POPIQ-7) short-form scores were obtained directly from the individual items on the longer forms. Similarly, the questions from the full-length PISQ that make up the PISQ-12 were extracted from the long form in the ASC group to compare with the PISQ-12 scores in the RSC group.
A sample-size calculation was performed with OpenEpi software (version 2.3.1). Using previously published data, we assumed the median failure rate (ie, reoperation for prolapse) 6 months to 3 years after ASC was 4.4%. Long-term outcome data for RSC are lacking, although some studies quote failure rates with sacrocolpopexy as high as 18.2%, which signifies a clinically meaningful difference in outcomes. With a 1:3 ratio of RSC to ASC patients, we determined that we would need 40 women who underwent RSC and 120 women who underwent ASC to have 80% power to distinguish a clinically meaningful difference in outcomes (ie, 4.4-18.2%) with an alpha level of .05.
Categoric variables were analyzed with χ 2 test or Fisher’s exact test; continuous variables were analyzed with the Student t tests; ranked variables were analyzed with the Mann Whitney U test. Logistic regression analyses were used to control for potential confounding variables. Two-tailed probability values, relative risks, and confidence intervals were calculated; a probability value of < .05 was considered to be statistically significant. All analyses were performed with SPSS software (version 19.0 for Mac; SPSS Inc, Chicago, IL). Data are presented according to strengthening the reporting of observational studies in epidemiology guidelines.
Results
Our study population included 125 women who underwent RSC with 1 attending surgeon during the study period and 322 women who underwent ASC as part of the CARE trial. Baseline characteristics were similar between groups with respect to age, race, body mass index, and advanced prolapse stage ( Table 1 ). However, the women who underwent RSC were slightly less parous and had a longer duration of follow up. Concomitant surgeries and perioperative complications are listed in Table 2 . Midurethral slings were performed in 52 women (42%) who underwent RSC. Conversely, of the women who underwent ASC, 157 women (49%) received a Burch urethropexy for their antiincontinence procedure, based on their random placement in the CARE trial. More women in the RSC group underwent concomitant hysterectomy (49%) compared with the ASC group (28%; P < .01). Specifically, of those who received hysterectomy, the women were more likely to receive a supracervical hysterectomy in the RSC group (58/61 women [95%]) compared with the ASC group (9/91 women [10%]; P < .01). Fewer patients in the RSC group underwent concomitant posterior repair (8%) compared with the ASC group (22%), p < 0.01.
| Variable | Robotic sacrocolpopexy (n = 125) | Abdominal sacrocolpopexy (n = 322) | P value |
|---|---|---|---|
| Age, y a | 59.5 ± 9.8 | 60.9 ± 10.2 | .17 b |
| White race, n (%) | 117 (94) | 299 (93) | .99 c |
| Body mass index, kg/m 2a | 26.6 ± 5.7 | 27.1 ± 4.5 | .39 b |
| Parity d | 2 [1] | 3 [2] | < .01 e |
| Stage III/IV prolapsed, n (%) | 107 (86) | 278 (86) | .70 c |
| Length of follow up, mo a | 18.3 ± 6.7 | 11.7 ± 0.9 | < .01 b |
a Data are presented as mean ± SD;
| Variable | Robotic sacrocolpopexy (n = 125) | Abdominal sacrocolpopexy (n = 322) | P value |
|---|---|---|---|
| Operative characteristics | |||
| Estimated blood loss, mL a | 90.0 ± 89.3 | 227.9 ± 195.0 | < .01 b |
| Concomitant, n (%) | |||
| Stress urinary incontinence procedure | 52 (42) | 157 (49) | .17 c |
| Hysterectomy | 61 (49) | 91 (28) | < .01 c |
| Posterior repair | 10 (8) | 71 (22) | < .01 c |
| Perioperative complications, n (%) | |||
| Hemorrhage (estimated blood loss, >1000 mL) | 0 | 2 (0.6) | .51 d |
| Transfusion | 1 (0.8) | 3 (0.9) | 1.00 d |
| Cystotomy | 2 (1.6) | 2 (0.6) | .32 d |
| Wound disruption | 0 | 14 (4.3) | .01 d |
| Wound infection | 6 (4.8) | 11 (3.4) | .34 d |
| Febrile morbidity | 6 (4.8) | 35 (10.9) | .04 c |
| Deep venous thrombosis | 1 (0.8) | 1 (0.3) | .49 d |
| Pneumonia | 2 (1.6) | 2 (0.6) | .32 d |
| Ileus | 7 (5.6) | 37 (11.6) | .05 c |
For our primary outcome (bothersome vaginal bulge or repeat surgery for prolapse), there were no significant differences between the RSC and ASC groups, with low proportions of surgical failure for both groups (7/86 [8%] vs 12/304 women [4%], respectively; P = .16). Validated questionnaires were obtained in 84 women who underwent RSC and 304 women who underwent ASC. Two women in the RSC group did not return validated questionnaires but underwent repeat surgery for prolapse and therefore were considered surgical failures in the primary outcome analysis. In total, 3 women who underwent RSC underwent repeat surgery for prolapse, and all were posterior colporrhaphies. Five women who underwent ASC underwent repeat surgeries, which were anterior and/or posterior colporrhaphies. One subject in the RSC group who was not included as a surgical failure underwent reoperation for nerve entrapment in a laparoscopic port site with complete resolution of abdominal wall pain. There were no repeat surgeries for vault prolapse in either group.
Because of the potential for differences in robotic surgical outcomes based on the learning curve, we performed a subanalysis in our RSC group. We compared our primary composite outcome of women who received RSC at UNC (March 2006–March 2007) with those who received RSC at Duke (April 2007–April 2009). In this subanalysis, we found similar proportions of surgical failure in both groups (1/20 women [5%] at UNC vs 6/65 women [9%] at Duke; P = 1.00).
To address the longer follow-up period in the RSC group, we performed another subanalysis of women with physical examination data at least 1 year after surgery (RSC group, 70 women; ASC group, 289 women). There were no significant differences in anatomic failure (apical descent more than one-third of the vaginal canal or any prolapse beyond the hymen) between the RSC and ASC groups (4/70 [6%] vs 16/289 women [6%], respectively; P = .57]. Median postoperative POP-Q points were similar between groups ( Table 3 ). In a logistic regression analysis that controlled for parity, concomitant hysterectomy, and concomitant posterior repair, there were still no differences between RSC and ASC groups for our primary composite outcome or for our secondary anatomic outcomes.
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