Background
Colpocleisis, a vaginal obliterative procedure, offers women with symptomatic pelvic organ prolapse an effective, durable anatomic repair and is associated with high patient satisfaction rates. Historically, colpocleisis was reserved for the medically frail or elderly with the goal of limiting anesthetic exposure, decreasing operative time, and minimizing adverse events. Several colpocleisis and colpectomy procedures exist and limited evaluation has been performed comparing these differences in regards to perioperative adverse events.
Objective
The primary objective was to describe the overall rate of perioperative adverse events in patients undergoing colpocleisis. The secondary objective was to compare rates of adverse events between different colpocleisis procedures.
Study Design
This is a retrospective chart review of patients who underwent colpocleisis at a tertiary care center from January 2003 through December 2013. Subjects were identified by their Current Procedural Terminology ( CPT ) codes and categorized into 3 groups: (1) partial or complete vaginectomy/colpectomy ( CPT 57106, 57110); (2) vaginal hysterectomy with total or partial colpectomy ( CPT 58275, 58280); and (3) Le Fort colpocleisis ( CPT 57120). Baseline demographics, perioperative data, and postoperative data were collected. Analysis of variance was used to describe perioperative and postoperative adverse events in all subjects and to compare outcomes among the 3 groups.
Results
In all, 245 subjects underwent colpocleisis during the study period. Mean age and body mass index were 78 (±7) years and 27.7 (±5.8) kg/m 2 , respectively; 59.1% (140/245) of subjects had stage-4 prolapse. The most common adverse event was urinary tract infection occurring in 34.7% of subjects. Major adverse events were uncommon. There were no differences in event rates among the groups except for the following: patients undergoing concurrent vaginal hysterectomy had longer mean operative time (144 vs 108 vs 111 minutes, P = .0001), had higher estimated blood loss (253 vs 135 vs 146 mL, P = .0001), and were more likely to experience postoperative venous thromboembolism (4.6% vs 0% vs 0%, P = .01). After controlling for age, body mass index, medical comorbidities, estimated blood loss, and operative time, the risk of venous thromboembolism was no longer significant.
Conclusion
The overall rate of major perioperative and postoperative adverse events in women undergoing colpocleisis is low; however, concomitant hysterectomy is associated with longer operative times and higher blood loss.
Introduction
Surgical management of symptomatic pelvic organ prolapse can be classified as either reconstructive or obliterative. The decision to proceed with either a reconstructive or obliterative procedure is dependent on many factors, including the patient’s perception of her desired outcome, current and future sexual activity, the risks and benefits of each intervention, and the patient’s medical comorbidities.
Colpocleisis is an obliterative vaginal procedure that is commonly performed for symptomatic pelvic organ prolapse in women who no longer desire coital function and/or who have significant medical comorbidities or are deemed medically frail. Women with uterovaginal prolapse have the option to undergo colpectomy with concomitant vaginal hysterectomy, or they may choose to undergo colpectomy with uterine preservation, also known as Le Fort colpocleisis. For posthysterectomy prolapse, either partial or total colpectomy can be performed. The goal of all obliterative procedures is to treat the prolapse by decreasing the vaginal length and narrowing the genital hiatus through a vaginal approach. These procedures have been shown to have excellent long-term subjective and anatomic success rates as well as high patient satisfaction rates.
Review of the literature shows that colpocleisis is associated with fewer adverse events compared to vaginal reconstructive surgery with a complication rate ranging from 8.1-19.1%. The majority of studies evaluating colpocleisis procedures have focused on anatomical outcomes and quality of life measures. Very few studies have focused on perioperative morbidity associated with the procedure, and those that have reported adverse events were limited by sample size or study design. Additionally, few studies have primarily examined the effect of concurrent hysterectomy on the incidence of adverse events following colpocleisis. Therefore, the objectives of this study are to describe perioperative adverse events in a large cohort of women who have undergone colpocleisis for the treatment of uterovaginal and posthysterectomy vaginal vault prolapse and to compare the incidence of perioperative events between colpocleisis procedures.
Materials and Methods
This is a retrospective cohort study of women who underwent colpocleisis for uterovaginal or posthysterectomy vaginal vault prolapse at a tertiary care referral center from January 2003 through December 2013. Following institutional review board approval, subjects were identified by their Current Procedural Terminology ( CPT ) codes and were placed in 1 of 3 groups: (1) partial or complete vaginectomy/colpectomy ( CPT 57106, 57110); (2) vaginal hysterectomy with total or partial colpectomy ( CPT 58275, 58280); and (3) Le Fort colpocleisis ( CPT 57120).
During this study period, 6 providers performed colpocleisis procedures. At our institution, it is standard practice to perform a posterior colporrhaphy with a levator myorrhaphy along with routine cystoscopy in all patients undergoing obliterative procedures. Additionally, patients may undergo concurrent antiincontinence procedures based on their perioperative symptoms and/or urodynamic findings.
All detailed operative reports were reviewed to ensure that a colpocleisis procedure had been performed. Once all patients were identified, the systemwide electronic medical record was queried for demographic, perioperative, and postoperative data. Operative data were collected from the detailed operative notes and included: type of colpocleisis performed, concomitant procedures, operating time (incision to closure), intraoperative injuries (bowel, vessel, bladder, ureter, and/or urethra), and estimated blood loss. All charts were reviewed following the surgical procedure to identify significant postoperative events.
Strict definitions were used to record postoperative adverse events for all patients. Cardiac, pulmonary, gastrointestinal, and/or vascular thrombotic events were captured if they occurred during the perioperative course. Cardiac events included acute coronary syndrome, myocardial infarction, and/or congestive heart failure. Pulmonary events included pulmonary edema, pulmonary hypertension, and/or pneumonia and gastrointestinal events included a diagnosis of an ileus and/or bowel obstruction. All events were recorded if they occurred within 30 days following the surgical procedure. Vascular events were included if a venous thromboembolism (VTE) was diagnosed via radiologic imaging within 90 days of the surgical procedure. Additionally, admission to the intensive care unit, return to the operating room, and data on radiographic imaging directly related to the surgical procedure were recorded. Lastly, the presence of a urinary tract infection, which was defined as symptoms of urgency/frequency/dysuria and/or a positive urine culture (10 5 colony-forming units) within 6 weeks after the surgical procedure, was recorded. Date of last follow-up was defined as the last clinic visit where a pelvic examination was performed and a review of systems included questions specific to pelvic organ prolapse symptoms.
This was primarily a descriptive study. Summary statistics were calculated for all groups and subgroups and were reported as n/N (%) with 95% confidence intervals (CI) for categorical variables and as mean ± SD and median (range) for all continuous variables. Comparisons of outcomes were performed using Student t test, analysis of variance for parametric continuous outcomes, Kruskal-Wallis for nonparametric continuous outcomes, and χ 2 tests for all categorical variables. Logistic and linear regression analyses were used to identify independent risk factors for the risk of perioperative adverse events associated with colpocleisis. All tests were 2-sided and considered significant at a .05 level. Software (JMP 10.0; SAS, Cary, NC) was used for all statistical analyses.
Materials and Methods
This is a retrospective cohort study of women who underwent colpocleisis for uterovaginal or posthysterectomy vaginal vault prolapse at a tertiary care referral center from January 2003 through December 2013. Following institutional review board approval, subjects were identified by their Current Procedural Terminology ( CPT ) codes and were placed in 1 of 3 groups: (1) partial or complete vaginectomy/colpectomy ( CPT 57106, 57110); (2) vaginal hysterectomy with total or partial colpectomy ( CPT 58275, 58280); and (3) Le Fort colpocleisis ( CPT 57120).
During this study period, 6 providers performed colpocleisis procedures. At our institution, it is standard practice to perform a posterior colporrhaphy with a levator myorrhaphy along with routine cystoscopy in all patients undergoing obliterative procedures. Additionally, patients may undergo concurrent antiincontinence procedures based on their perioperative symptoms and/or urodynamic findings.
All detailed operative reports were reviewed to ensure that a colpocleisis procedure had been performed. Once all patients were identified, the systemwide electronic medical record was queried for demographic, perioperative, and postoperative data. Operative data were collected from the detailed operative notes and included: type of colpocleisis performed, concomitant procedures, operating time (incision to closure), intraoperative injuries (bowel, vessel, bladder, ureter, and/or urethra), and estimated blood loss. All charts were reviewed following the surgical procedure to identify significant postoperative events.
Strict definitions were used to record postoperative adverse events for all patients. Cardiac, pulmonary, gastrointestinal, and/or vascular thrombotic events were captured if they occurred during the perioperative course. Cardiac events included acute coronary syndrome, myocardial infarction, and/or congestive heart failure. Pulmonary events included pulmonary edema, pulmonary hypertension, and/or pneumonia and gastrointestinal events included a diagnosis of an ileus and/or bowel obstruction. All events were recorded if they occurred within 30 days following the surgical procedure. Vascular events were included if a venous thromboembolism (VTE) was diagnosed via radiologic imaging within 90 days of the surgical procedure. Additionally, admission to the intensive care unit, return to the operating room, and data on radiographic imaging directly related to the surgical procedure were recorded. Lastly, the presence of a urinary tract infection, which was defined as symptoms of urgency/frequency/dysuria and/or a positive urine culture (10 5 colony-forming units) within 6 weeks after the surgical procedure, was recorded. Date of last follow-up was defined as the last clinic visit where a pelvic examination was performed and a review of systems included questions specific to pelvic organ prolapse symptoms.
This was primarily a descriptive study. Summary statistics were calculated for all groups and subgroups and were reported as n/N (%) with 95% confidence intervals (CI) for categorical variables and as mean ± SD and median (range) for all continuous variables. Comparisons of outcomes were performed using Student t test, analysis of variance for parametric continuous outcomes, Kruskal-Wallis for nonparametric continuous outcomes, and χ 2 tests for all categorical variables. Logistic and linear regression analyses were used to identify independent risk factors for the risk of perioperative adverse events associated with colpocleisis. All tests were 2-sided and considered significant at a .05 level. Software (JMP 10.0; SAS, Cary, NC) was used for all statistical analyses.
Results
In all, 245 subjects underwent colpocleisis during the study period. Mean age and body mass index were 78 (±7) years and 27.7 (±5.8) kg/m 2 , respectively; and 59.1% (140/245) of subjects presented with stage-4 prolapse. Colpectomy alone was performed in 134 (54.7%) subjects, vaginal hysterectomy plus colpectomy in 65 (26.5%) subjects, and 46 (18.4%) subjects underwent Le Fort colpocleisis. Table 1 displays patient characteristics for all patients and for each colpocleisis type. Subjects who underwent Le Fort colpocleisis were older (80 vs 77 vs 77 years, P = .02) and had a lower median preoperative stage of prolapse (3 vs 4 vs 4, P = .03) compared to the other 2 groups. Patients who underwent colpectomy alone for posthysterectomy prolapse were more likely to have undergone previous pelvic organ prolapse surgery compared to the other groups (36.6 vs 7.7 vs 6.5%, P < .001). Otherwise, the patient groups were similar.
| All subjects, N = 245 | Colpectomy, N = 134 | TVH plus colpectomy, N = 65 | Le Fort colpocleisis, N = 46 | P value | |
|---|---|---|---|---|---|
| Patient characteristics | |||||
| Age [y], mean ± SD | 78 ± 6.9 | 77 ± 6.7 | 77 ± 6.9 | 80 ± 7.1 | .02 a |
| BMI [kg/m 2 ], mean ± SD | 27.7 ± 5.8 | 27.7 ± 5.2 | 28.1 ± 6.5 | 27.3 ± 6.3 | .83 |
| Prolapse stage, median (range) | 4 (2–4) | 4 (2–4) | 4 (2–4) | 3 (3–4) | .03 a |
| Current smoker, N (%) | 8 (3.3) | 7 (5.3) | 1 (1.59) | 0 (0) | .12 |
| Cardiac disease, N (%) | 186 (75.9) | 103 (77.9) | 45 (69.2) | 38 (82.6) | .25 |
| Pulmonary disease, N (%) | 22 (8.9) | 11 (8.2) | 6 (9.23) | 5 (10.9) | .85 |
| Previous prolapse surgery, N (%) | 57 (23.3) | 49 (36.6) | 5 (7.7) | 3 (6.52) | <.001 a |
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