Background
Although several different apical suspension procedures are available to women with pelvic organ prolapse, data on long-term efficacy and safety profiles are limited.
Objective
The primary aim of this study was to analyze longitudinal reoperation risk for recurrent prolapse among the 4 apical suspension procedures over 2 to 15 years. Secondary aims included evaluation of all-cause reoperation, defined as a repeated surgery for the indications of recurrent prolapse and adverse events, and total retreatment rate, which included a repeated treatment with another surgery or a pessary.
Study Design
This was a multicenter, retrospective cohort study within Kaiser Permanente Southern California that included women who underwent sacrocolpopexy, uterosacral ligament suspension, sacrospinous ligament fixation, or colpocleisis from January 2006 through December 2018. Women who underwent concomitant rectal prolapse repair or vaginal prolapse repair with mesh augmentation were excluded. Data were abstracted using procedural and diagnostic codes through July 2021, with manual review of 10% of each variable. Patient demographics and pessary use were compared using analysis of variance or chi square tests for continuous and categorical variables, respectively. Time-to-event analysis was used to contrast reoperation rates. A Cox regression model was used to perform an adjusted multivariate analysis of the following predictors of reoperation for recurrence: index surgery, concomitant procedures, patient demographics, baseline comorbidities, and year of index surgery. Censoring events included exit from the health maintenance organization and death.
Results
The cohort included 9681 women with maximum follow-up of 14.8 years. The overall incidence of reoperation for recurrent prolapse was 7.4 reoperations per 1000 patient-years, which differed significantly by type of apical suspension ( P <.0001). The incidence of reoperation was lower after colpocleisis (1.4 events per 1000 patient-years) and sacrocolpopexy (4.8 events per 1000 patient-years) when compared with uterosacral ligament suspension (9 events per 1000 patient-years) and sacrospinous ligament fixation (13.9 events per 1000 patient-years). All pairwise comparisons between procedures were significant ( P =.0003–.0018) after correction for multiplicity, except for uterosacral ligament suspension or uterosacral ligament hysteropexy vs sacrospinous ligament fixation or sacrospinous ligament hysteropexy ( P =.05). The index procedure was the only significant predictor of reoperation for recurrence ( P =.0003–.0024) on multivariate regression analysis.
Reoperations for complications or sequelae (overall 2.9 events per 1000 patient-years) also differed by index procedure ( P <.0001) and were highest after sacrocolpopexy (4.4 events per 1000 patient-years). The incidence of all-cause reoperation for recurrence and adverse events after sacrocolpopexy, however, was comparable to that of the other reconstructive procedures ( P =.1–.4) in pairwise comparisons with Bonferroni correction. Similarly, frequency of pessary use differed by index procedure ( P <.0001) and was highest after sacrospinous ligament fixation at 9.3% (43/464).
Conclusion
Among nearly 10,000 patients undergoing prolapse surgery within a large managed care organization, colpocleisis and sacrocolpopexy offered the most durable obliterative and reconstructive prolapse repairs, respectively. All-cause reoperation rates were lowest after colpocleisis by a large margin, but similar among reconstructive apical suspension procedures.
Introduction
Although several different apical suspension procedures are available to women with pelvic organ prolapse (POP), data on long-term efficacy and safety profiles are limited. , Furthermore, these data are difficult to compare across studies because of differences in outcome measurement. There is currently no consensus on how to report surgical outcomes, which has been a long-debated topic. , Discrepancies among reported outcomes may pose a challenge to surgeons when helping patients determine which surgery is “best” for them.
Why was this study conducted?
This study aimed to quantify the reoperation rate for recurrent pelvic organ prolapse after the 4 major apical suspension procedures over a follow-up period of 15 years.
Key findings
Reoperation for recurrent prolapse was overall low after apical suspension. However, colpocleisis offered the most durable prolapse repair with the lowest all-cause reoperation and total retreatment rates. Of the reconstructive procedures, sacrocolpopexy demonstrated the most durable prolapse repair with a similar all-cause reoperation rate to those of the other procedures. Uterosacral ligament suspension and sacrospinous ligament fixation seemed to be comparable in durability, but sacrospinous ligament fixation was associated with a higher rate of retreatment with pessary.
What does this add to what is known?
This study summarizes the rate of reoperation for recurrent pelvic organ prolapse in the largest and longest-followed retrospective cohort to date. Reoperation is a clinically meaningful and patient-centered measure of surgical efficacy. This information is indispensable to surgeons during preoperative counseling and can help facilitate shared decision-making with patients.
Reoperation rate is a clinically meaningful measure that can help both surgeons and patients select the procedure that most closely aligns with their goals. Reoperation does not take into account patients who opt for expectant or conservative management. However, it describes the subset of women whose symptoms are bothersome enough to warrant undergoing another surgery. High-quality data show reoperation rates for recurrent prolapse of up to 11% after reconstructive native-tissue vaginal repairs at 5 years and 5.1% after sacrocolpopexy at 7 years. The available literature on colpocleisis largely focuses on subjective postoperative outcomes. , Obstacles to generalizability of these studies include low power and variable follow-up durations.
Investigation of this topic in a large patient sample with longitudinal follow-up may offer a bird’s-eye perspective that can be valuable to surgeons in counseling patients before prolapse surgery. The primary aim of this study is to compare the reoperation rates for recurrent POP over a follow-up period of 15 years among the 4 primary apical suspension procedures: sacrocolpopexy or sacrohysteropexy (SCP); uterosacral ligament suspension or uterosacral ligament hysteropexy (USLS); sacrospinous ligament fixation or sacrospinous ligament hysteropexy (SSLF); and colpocleisis with or without uterine preservation (CC).
Materials and Methods
This was a multicenter, retrospective cohort study conducted within Kaiser Permanente Southern California (KPSC), a large managed care organization with a population of 4.5 million patients. Approval by the KPSC Institutional Review Board (#043257) was obtained. The study population consisted of women aged >18 years with available demographic information within the electronic medical record (EMR) who underwent SCP, USLS, SSLF, or CC from January 1, 2006 through December 31, 2018. Exclusion criteria included concomitant rectal prolapse repair using vaginal mesh or graft or cadaveric implants. Patients who underwent concomitant synthetic midurethral sling placement were included in analysis. Data were abstracted from January 1, 2006 through July 25, 2021.
Current Procedural Terminology (CPT) and International Classification of Diseases (ICD) Ninth or Tenth Revision codes were used to identify the cohort and relevant outcome measures. To account for changes in CPT codes over the 15-year study period and to optimize accuracy, we used internal Kaiser procedural identification codes. A patient’s first apical suspension surgery within the EMR was considered her index surgery because surgeries performed at outside facilities or before EMR implementation in 2006 could not be reliably identified. At present, procedure codes are unable to distinguish between hysteropexy and vault suspension, thus these procedures were grouped by apical support type. Similarly, the USLS cohort included vaginal and endoscopic procedures because route could not be reliably determined. The SCP cohort included both open and minimally invasive approaches to maximize power because their efficacy is considered comparable. , Manual review of the KPSC surgical implant database was performed to exclude patients with mesh or graft augmentation at the time of index vaginal prolapse repair. Manual review of 10% of each variable was conducted to ensure validity of data abstraction. Patient demographics and comorbidities were abstracted directly from the EMR.
The primary outcome consisted of the number of patients who underwent reoperation for POP in any compartment (anterior, posterior, apical). If a patient underwent more than 1 reoperation for prolapse following her index surgery, only the first reoperation was analyzed. Secondary outcomes included all-cause reoperation and total retreatment rates. All-cause reoperation was defined as reoperation for recurrent POP and complications or sequelae of the index surgery. Again, only the first reoperation for adverse events was considered. For all-cause reoperation, time to the first reoperation—either for recurrence or complications or sequelae—was analyzed.
A comprehensive enumeration of procedures was considered to provide the most conservative estimate of reoperation in this limited retrospective study and to include information valuable to patients. Surgeons and patients perceive postoperative sequelae differently. , Over half of patients classify any type of reoperation after surgery as a severe complication. For this reason, procedures with any plausible relation to the index surgery, such as repair of rectal prolapse that may result from altered postoperative intrapelvic vector forces, were included.
Reoperation data were abstracted using KPSC procedural codes. Reoperations for adverse events were associated with relevant ICD codes and temporal criteria ( Supplemental Table 1 ). Indications unrelated to the index surgery ( Supplemental Table 2 ) were excluded. The following procedures were reviewed manually for pertinence to the index surgery: exploratory or diagnostic laparoscopy or laparotomy, ureteral stent placement, incisional hernia repair, mesh excision, and fecal diversion. The retreatment rate was defined as treatment after the index surgery with a repeated prolapse surgery and/or pessary, identified using CPT and ICD codes.
Statistical analysis was performed with SAS, version 7.15 (SAS Institute Inc, Cary, NC). Patient demographics and postoperative pessary use were summarized using descriptive statistics and compared using analysis of variance or chi square tests for continuous and categorical variables, respectively. Reoperation rates were compared using chi square tests; time-to-event distributions for reoperations were contrasted with the log-rank test. Bonferroni correction for multiplicity was performed for all pairwise comparisons. Censoring events included exit from the Kaiser system and death. Although the study population was anticipated to receive virtually all medical care within KPSC, retention was assessed using medical encounters within the EMR. A patient was considered to have exited the Kaiser system if no encounters were found for ≥1 year.
Multivariate analysis using a Cox proportional-hazards model with Firth correction evaluated the following predictors of reoperation for recurrent prolapse: index surgery, concomitant procedures (hysterectomy, adnexal procedures, compartment repairs, incontinence procedures), patient characteristics (age, race or ethnicity, body mass index [BMI], parity, smoking status, menopausal status, vaginal estrogen use), comorbidities (connective tissue disorders, bleeding disorders, chronic obstructive pulmonary disease, diabetes mellitus), and year of index surgery. Of note, race was included to better understand existing health disparities. Several covariates were removed from the CC Cox regression where very low numbers precluded model convergence.
Results
The cohort included 9681 patients ( Figure 1 ) across 11 medical centers. The total duration of follow-up was 14.8 years for SCP, 14.6 years for USLS, 14 years for SSLF, and 13.5 years for CC. Demographic characteristics and patient comorbidities are shown in Table 1 . The CC group was noted to be significantly older ( P <.0001) with increased medical comorbidities ( P <.0001). Minor differences in BMI ( P <.0001) and parity ( P <.0001) were seen across groups.
| Variable | All patients (N=9681) | SCP (n=2791) | USLS (n=5581) | SSLF (n=464) | CC (n=845) | P value |
|---|---|---|---|---|---|---|
| Age in y, mean (SD) | 60.6 (11.6) | 60.8 (9.4) | 57.6 (11) | 64.7 (10.3) | 77.1 (6.8) | <.0001 |
| BMI in kg/m 2 , mean (SD) | 28.0 (5) | 27.7 (4.5) | 28.5 (5.1) | 27.7 (5.2) | 26.2 (4.7) | <.0001 |
| Parity (%) | <.0001 | |||||
| 0–1 | 861 (8.9) | 239 (8.6) | 493 (8.8) | 53 (11.4) | 76 (9) | |
| 2–3 | 5393 (55.7) | 1566 (56.1) | 3179 (57) | 243 (52.4) | 405 (47.9) | |
| ≥4 | 2607 (26.9) | 727 (26) | 1494 (26.8) | 107 (23.1) | 279 (33) | |
| Unknown | 820 (8.5) | 259 (9.3) | 415 (7.4) | 61 (13.1) | 85 (10.1) | |
| Postmenopausal (%) | 8086 (83.5) | 2480 (88.9) | 4329 (77.6) | 432 (93.1) | 845 (100) | <.0001 |
| Race/ethnicity (%) | <.0001 | |||||
| White | 3892 (40.2) | 1160 (41.6) | 2121 (38) | 224 (48.3) | 387 (45.8) | |
| Black | 515 (5.3) | 118 (4.2) | 323 (5.8) | 36 (7.8) | 38 (4.5) | |
| Hispanic | 4674 (48.3) | 1347 (48.3) | 2802 (50.2) | 187 (40.3) | 338 (40) | |
| Asian/PI | 527 (5.4) | 147 (5.3) | 288 (5.2) | 14 (3) | 78 (9.2) | |
| Other/unknown | 73 (0.8) | 19 (0.7) | 47 (0.8) | 3 (0.6) | 4 (0.5) | |
| Smoking status (%) | .0005 | |||||
| Current | 347 (3.6) | 87 (3.1) | 226 (4) | 19 (4.1) | 15 (1.8) | |
| Former | 2143 (22.1) | 610 (21.9) | 1189 (21.3) | 120 (25.9) | 224 (26.5) | |
| Never | 7190 (74.3) | 2093 (75) | 4166 (74.6) | 325 (70) | 606 (71.7) | |
| Unknown | 1 (0) | 1 (0) | 0 (0) | 0 (0) | 0 (0) | |
| Vaginal estrogen | 4330 (44.7) | 1362 (48.8) | 2058 (36.9) | 292 (62.9) | 618 (73.1) | <.0001 |
| Comorbidities (%) | ||||||
| Diabetes mellitus | 1858 (19.2) | 536 (19.2) | 932 (16.7) | 102 (22) | 288 (34.1) | <.0001 |
| Chronic obstructive pulmonary disease | 161 (1.7) | 40 (1.4) | 73 (1.3) | 15 (3.2) | 33 (3.9) | <.0001 |
| Connective tissue disorder | 862 (8.9) | 236 (8.5) | 434 (7.8) | 57 (12.3) | 135 (16) | <.0001 |
| Coagulopathy | 242 (2.5) | 61 (2.2) | 118 (2.1) | 21 (4.5) | 42 (5) | <.0001 |
| Index year (%) | <.0001 | |||||
| 2006–2010 | 1975 (20.4) | 779 (27.9) | 975 (17.5) | 92 (19.8) | 129 (15.3) | |
| 2011–2015 | 4719 (48.7) | 1180 (42.3) | 2895 (51.9) | 217 (46.8) | 427 (50.5) | |
| 2016–2018 | 2987 (30.9) | 832 (29.8) | 1711 (30.7) | 155 (33.4) | 289 (34.2) | |
| Concomitant procedures | ||||||
| Hysterectomy | 7044 (72.8) | 1734 (62.1) | 5039 (90.3) | 140 (30.2) | 131 (15.5) | <.0001 |
| Adnexal surgery | 2914 (30.1) | 1049 (37.6) | 1771 (31.7) | 53 (11.4) | 41 (4.9) | <.0001 |
| Anterior repair | 3736 (38.6) | 682 (24.4) | 2700 (48.4) | 292 (62.9) | 62 (7.3) | <.0001 |
| Posterior repair/ perineorrhaphy | 5810 (60) | 1628 (58.3) | 3398 (60.9) | 273 (58.8) | 511 (60.5) | .14 |
| Incontinence procedure | 5521 (57) | 1882 (67.4) | 3038 (54.4) | 192 (41.4) | 409 (48.4) | <.0001 |
Reoperation for recurrence by index procedure is described in Table 2 as both the percentage of the total cohort and also as the incidence of events per 1000 patient-years to account for variable follow-up among patients. The overall rate of reoperation for recurrent prolapse in the cohort was 5.1%. The incidence of reoperation for recurrent prolapse was 7.4 reoperations per 1000 patient-years. This differed significantly by type of apical suspension ( P <.0001). The lowest incidence of reoperation for recurrent POP was seen after CC ( P <.0001). Significant differences were found in the following corrected pairwise comparisons of reoperation rates for recurrence: SCP vs USLS ( P =.0006), SCP vs SSLF ( P =.0006), SCP vs CC ( P =.0006), USLS vs CC ( P =.0006), and SSLF vs CC ( P =.0006). Reoperation rate did not significantly differ between USLS and SSLF ( P =.074) after correction for multiplicity. Similarly, pairwise comparisons of time-to-event distributions ( Figure 2 ) were significant ( P =.0003–.0018) after Bonferroni correction, except for USLS vs SSLF ( P =.05). A breakdown of the procedures performed for recurrent prolapse is shown in Table 3 . Of the 490 patients who underwent reoperation for recurrence, 23 (15 in USLS group, 5 in SCP group, 3 in SSLF group) proceeded to have a second reoperation, and 1 (USLS group) had a third reoperation.
| Outcome a | All patients (n=9681) | SCP (n=2791) | USLS (n=5581) | SSLF (n=464) | CC (n=845) | P value |
|---|---|---|---|---|---|---|
| Reoperation events for recurrent prolapse (%) | 490 (5.1) | 100 (3.6) | 341 (6.1) | 42 (9.1) | 7 (0.8) | <.0001 |
| Total patient-years of follow-up for recurrent prolapse | 66,469.1 | 20,626.9 | 37,793.8 | 3028.6 | 5019.8 | NA |
| Reoperations for recurrent prolapse per 1000 patient-years | 7.4 | 4.8 | 9 | 13.9 | 1.4 | <.0001 |
| Reoperation events for complications or sequelae (%) | 198 (2) | 92 (3.3) | 91 (1.6) | 4 (0.9) | 11 (1.3) | <.0001 |
| Total patient-years of follow-up for complications of sequelae | 67,998.5 | 20,686.8 | 39,113.4 | 3195 | 5003.3 | NA |
| Reoperations for complications or sequelae per 1000 patient-years | 2.9 | 4.4 | 2.3 | 1.3 | 2.2 | <.0001 |
a Outcomes not mutually exclusive, but only first reoperation in each category considered.
| Procedure for recurrent POP | Total patients requiring reoperation for recurrent POP (n=490) a | Index SCP (n=100) | Index USLS (n=341) | Index SSLF (n=42) | Index CC (n=7) | P value |
|---|---|---|---|---|---|---|
| SCP (%) | 130 (26.5) | 6 (6) | 111 (32.6) | 12 (28.6) | 1 (14.3) | <.0001 |
| USLS (%) | 16 (3.3) | 3 (3) | 13 (3.8) | 0 (0) | 0 (0) | .57 |
| SSLF (%) | 52 (10.6) | 14 (14) | 33 (9.7) | 5 (11.9) | 0 (0) | .50 |
| CC (%) | 35 (7.1) | 2 (2) | 20 (5.9) | 8 (19) | 5 (71.4) | <.0001 |
| Anterior repair (%) | 202 (41.2) | 39 (39) | 143 (41.9) | 19 (45.2) | 1 (14.3) | .43 |
| Posterior repair/perineorrhaphy (%) | 253 (51.6) | 66 (66) | 167 (49) | 16 (38.1) | 4 (57.1) | .008 |
| Paravaginal repair (%) | 37 (7.6) | 7 (7) | 29 (8.5) | 1 (2.4) | 0 (0) | .44 |
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