Background
There is a growing interest in combined pelvic organ prolapse and rectal prolapse surgery for concomitant pelvic floor prolapse despite a paucity of data regarding complications and clinical outcomes of combined repair.
Objective
The primary objective of this study was to compare the <30-day postoperative complication rate in women undergoing combined POP + RP surgery with that of women undergoing pelvic organ prolapse–only surgery. The secondary objectives were to describe the <30-day postoperative complications, compare the pelvic organ prolapse recurrence between the 2 groups, and determine the preoperative predictors of <30-day postoperative complications and predictors of pelvic organ prolapse recurrence.
Study Design
This was a multicenter, retrospective cohort study at 5 academic hospitals. Patients undergoing combined pelvic organ prolapse and rectal prolapse surgery were matched by age, pelvic organ prolapse stage by leading compartment, and pelvic organ prolapse procedure compared with those undergoing pelvic organ prolapse–only surgery from March 2003 to March 2020. The primary outcome measure was <30-day complications separated into Clavien-Dindo classes. The secondary outcome measures were (1) subsequent pelvic organ prolapse surgeries and (2) pelvic organ prolapse recurrence, defined as patients who complained of vaginal bulge symptoms postoperatively.
Results
Overall, 204 women underwent combined surgery for pelvic organ prolapse and rectal prolapse, and 204 women underwent surgery for pelvic organ prolapse only. The average age (59.3±1.0 vs 59.0±1.0) and mean parity (2.3±1.5 vs 2.6±1.8) were similar in each group. Of note, 109 (26.7%) patients had at least one <30-day postoperative complication. The proportion of patients who had a complication in the combined surgery group and pelvic organ prolapse–only surgery group was similar (27.5% vs 26.0%; P =.82). The Clavien-Dindo scores were similar between the groups (grade I, 10.3% vs 9.3%; grade II, 11.8% vs 12.3%; grade III, 3.9% vs 4.4%; grade IV, 1.0% vs 0%; grade V, 0.5% vs 0%). Patients undergoing combined surgery were less likely to develop postoperative urinary tract infections and urinary retention but were more likely to be treated for wound infections and pelvic abscesses than patients undergoing pelvic organ prolapse–only surgery. After adjusting for combined surgery vs pelvic organ prolapse–only surgery and parity, patients who had anti-incontinence procedures (adjusted odds ratio, 1.85; 95% confidence interval, 1.16–2.94; P =.02) and perineorrhaphies (adjusted odds ratio, 1.68; 95% confidence interval, 1.05–2.70; P =.02) were more likely to have <30-day postoperative complications. Of note, 12 patients in the combined surgery group and 15 patients in the pelvic organ prolapse–only surgery group had subsequent pelvic organ prolapse repairs (5.9% vs 7.4%; P =.26). In the combined surgery group, 10 patients (4.9%) underwent 1 repair, and 2 patients (1.0%) underwent 2 repairs. All patients who had recurrent pelvic organ prolapse surgery in the pelvic organ prolapse–only surgery group had 1 subsequent pelvic organ prolapse repair. Of note, 21 patients in the combined surgery group and 28 patients in the pelvic organ prolapse–only surgery group reported recurrent pelvic organ prolapse (10.3% vs 13.7%; P =.26). On multivariable analysis adjusted for number of previous pelvic organ prolapse repairs, combined surgery vs pelvic organ prolapse–only surgery, and perineorrhaphy at the time of surgery, patients were more likely to have a subsequent pelvic organ prolapse surgery if they had had ≥2 previous pelvic organ prolapse repairs (adjusted odds ratio, 6.06; 95% confidence interval, 2.10–17.5; P =.01). The average follow-up times were 307.2±31.5 days for the combined surgery cohort and 487.7±49.9 days for the pelvic organ prolapse–only surgery cohort. Survival curves indicated that the median time to recurrence was not statistically significant (log-rank, P =.265) between the combined surgery group (4.2±0.4 years) and the pelvic organ prolapse–only surgery group (5.6±0.4 years).
Conclusion
In this retrospective cohort study, patients undergoing combined pelvic organ prolapse and rectal prolapse surgery had a similar risk of <30-day postoperative complications compared with patients undergoing pelvic organ prolapse–only surgery. Furthermore, patients who underwent combined surgery had a similar risk of recurrent pelvic organ prolapse and subsequent pelvic organ prolapse surgery compared with patients who underwent pelvic organ prolapse–only surgery.
Introduction
Pelvic floor weakness can lead to protrusion of the bladder, rectum, small bowel, uterus, and/or vaginal cuff through the vagina and/or protrusion of the mucosa or full thickness of the rectum through the anal canal. Patients with severely attenuated pelvic floor support can present with simultaneous prolapse of both the rectum and the adjacent pelvic organs. In patients presenting with rectal prolapse (RP), the concurrent rate of pelvic organ prolapse (POP) is between 21% and 34%. For women with both POP and RP, there is an increasing trend to offer concomitant combined surgical repair as part of a multidisciplinary evaluation and treatment approach. A recent American College of Surgeons National Surgical Quality of Improvement Program (ACS NSQIP) study has demonstrated that the number of combined POP + RP surgeries has increased from 2.6% to 7.0% during the past decade. The advantages of 1 combined prolapse operation include a reduced risk of anesthesia, a single hospital stay and recovery period, decreased pain medications, and less time off of work for the patient.
Why was this study conducted?
This study aimed to compare the <30-day postoperative complications and pelvic organ prolapse (POP) recurrence in women undergoing combined pelvic organ prolapse and rectal prolapse (POP + RP) surgery with that of women undergoing POP-only surgery.
Key findings
Patients undergoing combined POP + RP surgery had a similar risk of <30-day complications, recurrent POP, and subsequent POP surgery compared with patients undergoing POP-only surgery.
What does this add to what is known?
Patients who are candidates for combined POP + RP surgery can be counseled that they are likely to have similar postoperative complication rates and POP recurrence rates compared with those patients undergoing POP-only surgery.
POP and RP can be treated with an array of surgical procedures. POP surgery can be performed using a vaginal approach, a minimally invasive abdominal approach, or an open abdominal approach. Similarly, for patients with RP, surgery can be performed by a perineal approach, a minimally invasive abdominal approach, or an open abdominal approach. Mesh grafts can be used in both POP and RP surgeries to improve durability and reduce prolapse recurrence. Perineal approaches to RP repair have higher recurrence rates and higher reoperation rates than abdominal rectopexy, but these procedures avoid entry into the abdomen. Similarly, native tissue POP repairs are typically performed transvaginally and avoid abdominal entry. However, data suggest that abdominal sacrocolpopexy (ASC) provides better objective anatomic outcomes than native tissue POP repairs. The surgical approach is often determined by surgeon preference and experience, the patient’s goals, medical comorbidities, frailty, and history and type of previous prolapse repairs.
Women with both vaginal prolapse and RP likely represent a patient population with more severe pelvic floor dysfunction. Postoperatively, these patients may be at increased risk of complications and prolapse recurrence. However, treatment outcomes in this subgroup with concomitant prolapse have not been well described and are poorly understood. There are limited data on the equivalency of complication rates and prolapse recurrence rates between combined surgery and POP-only surgery. Previous studies of combined POP + RP surgery are limited by small cohort sizes, short follow-up periods, and lack of comparison groups. , Surgeons may offer patients combined POP + RP repair but have little data on how to counsel patients regarding their risk of postoperative complications or POP recurrence compared with POP-only surgery.
Here, our primary objective was to compare the <30-day postoperative complication rate in women undergoing combined POP + RP surgery with that of women undergoing POP-only surgery. Our secondary objectives were to describe the <30-day postoperative complications, compare the POP recurrence rate between the 2 groups, and determine preoperative predictors of <30-day complications and POP recurrence in this cohort.
Materials and Methods
This was a multicenter, retrospective cohort study at 5 academic hospitals that was conducted through the American Urogynecologic Society (AUGS) and Society of Gynecologic Surgeons (SGS) Fellows Pelvic Research Network (FPRN). The FPRN is a US multicenter research consortium of Female Pelvic Medicine and Reconstructive Surgery (FPMRS) fellows, overseen by the SGS and the AUGS. This study included 5 clinical sites, and institutional review board approval was obtained at each institution. This study was conducted and data were abstracted between March 2019 and July 2021.
Women aged ≥18 years were included in this study, and patients were identified using the Current Procedural Terminology (CPT) codes for perineal or abdominal RP repair and transvaginal or abdominal POP repair ( Appendix ). Codes assigned on the same day indicated combined surgery. We included codes for Delorme or Altemeier procedures, suture or mesh rectopexy with or without resection, colpocleisis, vaginal or abdominal colpopexy, and posterior repair and/or anterior repair. Codes for hemorrhoidectomy, anti-incontinence procedures, or perineorrhaphy were excluded.
Patients undergoing combined POP + RP surgery were matched by age, POP stage by leading compartment, and POP procedure compared with those undergoing POP-only surgery. Cases were defined as patients who underwent combined POP + RP surgery and were matched in a 1:1 ratio with control patients undergoing POP-only surgery. The surgical window was from March 2003 to March 2020, and cases and controls were matched in this time frame. The protocol for the identification of cases and subsequent matching to controls was standardized across institutions to reduce selection bias. Cases and controls were matched at each institution to reduce the effect of institutional bias. Eligible patients who underwent combined POP + RP surgery were first identified as cases. The procedure for each case was defined by CPT codes. All controls who had the same CPT codes were matched to a case. Procedure matching was performed by both procedure type (mesh-augmented sacrocolpopexy vs native tissue repair) and approach (transvaginal vs minimally invasive abdominal vs open abdominal). Patients were not matched for hysterectomy or anti-incontinence procedure performed at the time of POP surgery. POP stage matching was performed by matching the most severe POP compartment (apical, anterior, or posterior) of a case patient to the same-stage compartment in the control patients. The control patients who did not have the same-stage prolapse were excluded. The Pelvic Organ Prolapse Quantification (POP-Q) system was used to determine the POP stage. Finally, cases and controls were age matched within 2 years of their age at the time of surgery. To reduce selection bias, investigators were instructed to match each case to an appropriately matched control using the control with the first letter of their last name that appears the earliest in the alphabet.
Demographic data, patient characteristics, physical examination findings (including the POP-Q), and perioperative data were collected from the electronic medical record (EMR). Surgical procedure and surgical approach for RP repair (abdominal vs perineal) and POP repair (abdominal vs transvaginal) were documented as well. All medical records were thoroughly reviewed for emergency department visits, inpatient visits, and outpatient visits that identified and described the diagnosis and management of postoperative complications.
Of note, <30-day postoperative surgical complications for the combined POP + RP surgery group and the POP-only surgery group were identified. The overall complication rates for each group were calculated and compared. Complications were separated into grades using the Clavien-Dindo (CD) system, which is a validated surgical complication grading system based on the invasiveness of the intervention used to treat a complication. Any reported case of urinary retention was defined as any patient who required a Foley catheter or clean intermittent catheterization for ≥7 days after surgery. Any reported case of “hemorrhage” or “hematoma” was classified as a “hemorrhage” for this study. Pulmonary complications included any case of pneumonia, acute respiratory distress syndrome, or pulmonary edema. Cardiac complications included myocardial infarction, congestive heart failure, and arrhythmias. Injuries to the bowel, bladder, or ureters were classified as “visceral injuries.” Complications excluded from the analysis included complications unrelated to the surgery, such as anesthesia complications (eg, spinal headache).
Data were abstracted until the date of the patient’s last FPMRS appointment, and the EMR was reviewed for any subsequent POP surgeries and POP recurrence. POP recurrence was defined as complaints of vaginal bulge symptoms postoperatively.
We powered our study to show twice the difference in <30-day postoperative complication rates between patients who underwent combined surgery and patients who underwent POP-only surgery. A recent study using the ACS NSQIP dataset found that 10.5% of women undergoing vaginal colpopexy for the treatment of POP experienced a postoperative complication. For RP, the rate of complications varies from 9.1% to 17% after perineal repair and 0% to 52% after abdominal repair in the literature. , , Thus, we assumed a postoperative complication rate of 10% after POP-only surgery and 20% after combined POP-RP surgery with a delta effect size of 10%. Of note, 200 patients in each group would be needed to provide 80% power for differentiating a complication rate difference of 10% between each cohort using a 5% level of significance. Descriptive statistics were presented as mean±standard deviation. Categorical variables were expressed in frequencies with percentages. Differences between groups were examined using the chi-squared or Fisher exact test, as appropriate. Comparisons of outcome measures were done using an analysis of variance or a Student t test for parametric continuous outcomes, a Kruskal-Wallis or Mann-Whitney U test for nonparametric outcomes, and a chi-squared test for all categorical outcomes. P values of <.05 were considered statistically significant. Univariate logistic regression was performed to evaluate demographic data, clinical characteristics, operative and postoperative factors associated with postoperative complications, subsequent POP surgeries, and POP recurrence. Moreover, we applied a backward selection of variables with P values of <.20 on univariate analysis. Multivariable logistic regression was fit for estimation of odds ratio (OR) and corresponding 95% confidence intervals (CIs) while adjusting for potential confounders. In each model, interaction terms were generated for the covariates to test for effect modification and subsequently removed from the model if they were not significant. Data and percentages have been presented for the combined surgery cohort followed by the POP-only surgery cohort. The Kaplan-Meier method was used to illustrate the difference in time to POP recurrence between the combined surgery cohort and the POP-only surgery cohort. Log-rank test was computed to compare crude survival functions between the cohorts. Analyses were done using the SAS software (version 9.4; SAS Institute, Cary, NC).
Results
Overall, 204 women underwent combined surgery for POP + RP, and 204 women underwent surgery for POP-only. Mean age (59.3±1.0 vs 59.0±1.0; P =.83) and parity (2.3±1.5 vs 2.6±1.8; P =.22) in each group were similar, and most women were White (75.5% vs 76.0%; P =.14). A higher proportion of patients who underwent combined surgery had lower body mass indices (25.3±0.4 vs 26.8±0.3; P <.001), were more likely to be current smokers (13.2% vs 4.4%; P <.01), were diagnosed with a connective tissue disorder (9.3% vs 2.0%; P <.01), and had a psychiatric diagnosis (37.2% vs 16.2%; P <.01) ( Table 1 ).
Patient characteristics | Total (n=408) | Combined POP+RP surgery Total (n=204) | POP-only surgery Total (n=204) | P value |
|---|---|---|---|---|
| Age | 59.3±1.0 | 59.0±1.0 | .83 | |
| Race/ethnicity | .14 | |||
| Caucasian | 309 | 154 (75.5) | 155 (76.0) | |
| Asian | 16 | 7 (3.4) | 9 (4.4) | |
| Black | 18 | 8 (3.9) | 10 (4.9) | |
| Hispanic | 49 | 22 (10.8) | 27 (13.3) | |
| Other | 11 | 8 (3.9) | 3 (1.5) | |
| Parity | .22 | |||
| 0 | 28 | 20 (9.80) | 8 (3.9) | |
| 1 | 50 | 28 (13.7) | 22 (10.8) | |
| 2 | 163 | 78 (38.2) | 85 (41.7) | |
| 3+ | 167 | 78 (38.2) | 89 (43.6) | |
| Avg | 2.3±1.5 | 2.6±1.8 | ||
| BMI | 25.2±0.4 | 26.8±0.3 | <.01 | |
| Smoking | <.01 | |||
| Nonsmoker | 285 | 126 (61.8) | 159 (77.9) | |
| Former smoker | 86 | 51 (25.0) | 35 (17.2) | |
| Current smoker | 36 | 27 (13.2) | 9 (4.4) | |
| ASA | <.01 | |||
| NA | 16 | 10 (4.9) | 6 (2.9) | |
| 1 | 24 | 6 (2.9) | 18 (8.8) | |
| 2 | 269 | 125 (61.3) | 144 (70.6) | |
| 3 | 99 | 63 (30.9) | 36 (17.7) | |
| Comorbidites | ||||
| Cardiac disease | 91 | 51 (25.0) | 40 (19.6) | .19 |
| Pulmonary disease | 75 | 45 (22.1) | 30 (14.7) | .06 |
| Connective tissue disorder | 23 | 19 (9.3) | 4 (2.0) | <.01 |
| Obesity (BMI >30) | 94 | 51 (25.0) | 43 (21.1) | .38 |
| Diabetes mellitus | 38 | 23 (11.3) | 15 (7.4) | .17 |
| Psychiatric diagnosis | 109 | 76 (37.3) | 33 (16.2) | <.01 |
| Previous pelvic floor surgeries | ||||
| Previous hysterectomy | 139 | 74 (36.3) | 66 (31.9) | .35 |
| Number of previous vaginal prolapse surgeries | .83 | |||
| None | 315 | 155 (76.0) | 160 (78.4) | |
| Yes 1 | 69 | 36 (17.7) | 33 (16.2) | |
| Yes 2+ | 24 | 13 (6.4) | 11 (5.4) | |
| Previous sling procedure | 52 | 22 (10.8) | 30 (14.7) | .24 |
| Number of previous rectal prolapse surgeries | <.01 | |||
| None | 375 | 171 (83.8) | 204 (100.0) | |
| Yes 1 | 27 | 27 (13.2) | 0 (0.0) | |
| Yes 2+ | 6 | 6 (2.9) | 0 (0.0) | |
| Previous therapies for vaginal prolapse | <.01 | |||
| None | 273 | 150 (73.5) | 123 (60.3) | |
| Pessary | 93 | 29 (14.2) | 64 (31.4) | |
| Pelvic floor physical therapy | 20 | 13 (6.4) | 7 (3.4) | |
| Pessary and pelvic floor physical therapy | 21 | 11 (5.4) | 10 (4.9) |
In each group, 68.1% of patients underwent abdominal POP repair, whereas 31.9% of patients underwent transvaginal POP repair only. Of the patients undergoing abdominal POP repair, more than two-thirds of patients underwent minimally invasive abdominal POP repair (69.4%), whereas less than one-third of patients underwent open abdominal POP repair (30.6%). More anti-incontinence procedures (36.8% vs 57.8%; P <.01) and hysterectomies (39.7% vs 48%; P =.09) were performed at the time of surgery in the POP-only cohort ( Table 2 ).
| Surgery | Total | Combined POP+RP Surgery | POP-only surgery | P value |
|---|---|---|---|---|
| Abdominal repair | .45 | |||
| No | 130 (31.9) | 65 (31.9) | 65 (31.9) | |
| Yes | 278 (68.1) | 139 (68.1) | 139 (68.1) | |
| Open | 85 (20.8) | 43 (21.1) | 42 (20.6) | |
| with mesh repair | 79 (19.4) | 40 (19.6) | 39 (19.1) | |
| with suture repair | 6 (1.5) | 3 (1.5) | 3 (1.5) | |
| Lap/robotic | 193 (47.3) | 96 (47.1) | 97 (23.8) | |
| with mesh repair | 173 (42.4) | 82 (40.2) | 91 (44.6) | |
| with suture repair | 20 (4.9) | 14 (6.86) | 6 (2.94) | |
| Vaginal repair | <.01 | |||
| No | 172 (42.2) | 100 (49.0) | 72 (35.3) | |
| Yes | 236 (57.8) | 104 (51.0) | 132 (64.7) | |
| Cystocele | 54 (13.2) | 25 (12.3) | 29 (14.2) | |
| Rectocele | 77 (18.9) | 38 (18.6) | 39 (19.1) | |
| Cystocele and rectocele | 36 (8.8) | 7 (3.4) | 29 (14.2) | |
| Apical suspension | 8 (2.0) | 3 (1.5) | 5 (2.5) | |
| Apical suspension and cystocele | 12 (2.9) | 7 (3.4) | 5 (2.5) | |
| Apical suspension and cystocele and rectocele | 12 (2.9) | 5 (2.5) | 7 (3.4) | |
| Apical suspension and rectocele | 7 (1.7) | 4 (2.0) | 3 (1.5) | |
| Colpocleisis | 30 (7.4) | 15 (7.4) | 15 (7.4) | |
| Perineorrhaphy | .07 | |||
| No | 287 (70.3) | 152 (74.5) | 135 (66.2) | |
| Yes | 121 (30.0%) | 52 (25.5) | 69 (33.8) | |
| Anti-incontinence procedure | <.01 | |||
| No | 215 (52.7) | 129 (63.2) | 86 (42.2) | |
| Yes | 193 (47.3) | 75 (36.8) | 118 (57.8) | |
| Hysterectomy at the time of POP repair | .09 | |||
| No | 229 (56.1) | 123 (60.3) | 106 (52.0) | |
| Yes | 179 (43.9) | 81 (39.7) | 98 (48.0) |
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