Incidence of adverse events after uterosacral colpopexy for uterovaginal and posthysterectomy vault prolapse




Objective


We sought to describe perioperative and postoperative adverse events associated with uterosacral colpopexy, to describe the rate of recurrent pelvic organ prolapse (POP) associated with uterosacral colpopexy, and to determine whether surgeon technique and suture choice are associated with these rates.


Study Design


This was a retrospective chart review of women who underwent uterosacral colpopexy for POP from January 2006 through December 2011 at a single tertiary care center. The electronic medical record was queried for demographic, intraoperative, and postoperative data. Strict definitions were used for all clinically relevant adverse events. Recurrent POP was defined as the following: symptomatic vaginal bulge, prolapse to or beyond the hymen, or any retreatment for POP.


Results


In all, 983 subjects met study inclusion criteria. The overall adverse event rate was 31.2% (95% confidence interval [CI], 29.2–38.6), which included 20.3% (95% CI, 17.9–23.6) of subjects with postoperative urinary tract infections. Of all adverse events, 3.4% were attributed to a preexisting medical condition, while all other events were ascribed to the surgical intervention. Vaginal hysterectomy, age, and operative time were not significantly associated with any adverse event. The intraoperative bladder injury rate was 1% (95% CI, 0.6–1.9) and there were no intraoperative ureteral injuries; 4.5% (95% CI, 3.4–6.0) of cases were complicated by ureteral kinking requiring suture removal. The rates of pulmonary and cardiac complications were 2.3% (95% CI, 1.6–3.5) and 0.8% (95% CI, 0.4–1.6); and the rates of postoperative ileus and small bowel obstruction were 0.1% (95% CI, 0.02–0.6) and 0.8% (95% CI, 0.4–1.6). The composite recurrent POP rate was 14.4% (95% CI, 12.4–16.8): 10.6% (95% CI, 8.8–12.7) of patients experienced vaginal bulge symptoms, 11% (95% CI, 9.2–13.1) presented with prolapse to or beyond the hymen, and 3.4% (95% CI, 2.4–4.7) required retreatment. Number and type of suture used were not associated with a higher rate of recurrence. Of the subjects who required unilateral removal of sutures to resolve ureteral kinking, 63.6% did not undergo suture replacement; this was not associated with a higher rate of POP recurrence.


Conclusion


Perioperative and postoperative complication rates associated with severe morbidity after uterosacral colpopexy appear to be low. Uterosacral colpopexy remains a safe option for the treatment of vaginal vault prolapse.


Pelvic organ prolapse (POP) is a common problem in women and is associated with considerable morbidity and a decreased quality of life. In the United States, the prevalence of POP is approximately 2.9% and nearly 300,000 women undergo surgery annually for prolapse. As a result, the estimated direct cost of POP surgery is >$1 billion per year.


Transvaginal and abdominal procedures exist to treat symptomatic POP. Uterosacral colpopexy is a common transvaginal procedure for vaginal prolapse and can be performed at the time of vaginal hysterectomy or for posthysterectomy vaginal vault prolapse. During this procedure, sutures are placed through the uterosacral ligaments, at or above the ischial spines and then anchored to the vaginal apex. In 2010, Margulies et al published a systematic review that found that uterosacral colpopexy anatomic success rates were favorable: 81.2%, 98.3%, and 87.4% for the anterior, apical, and posterior compartments, respectively. The recently published OPTIMAL trial reported that there were no significant differences in outcomes 2 years after transvaginal uterosacral colpopexy compared to sacrospinous ligament colpopexy. While there are a number of studies reporting on subjective and objective efficacy after uterosacral colpopexy, there are few large studies that specifically address the perioperative and postoperative adverse events of this procedure. Therefore, the primary objective of this study was to describe perioperative and postoperative adverse events associated with uterosacral colpopexy in a large cohort of women undergoing this procedure at a tertiary care center. Secondary aims were to describe the rate of recurrent POP associated with uterosacral colpopexy and to determine whether surgeon technique and suture choice were associated with these rates.


Materials and Methods


This was a retrospective chart review of all women who underwent uterosacral colpopexy with or without hysterectomy for POP from January 2006 through December 2011 at a single tertiary care referral center. Institutional review board approval for the study was obtained. Subjects were identified by their Current Procedural Terminology code for intraperitoneal colpopexy (57283). All subjects underwent transvaginal uterosacral colpopexy for either uterovaginal prolapse or posthysterectomy vaginal vault prolapse. At our institution, type of colpopexy (intraperitoneal vs extraperitoneal) is usually determined at the preoperative visit. All subjects who underwent colpopexy for uterovaginal prolapse also underwent vaginal hysterectomy. Subjects were included if they underwent concomitant transvaginal POP procedures or antiincontinence surgery with midurethral sling placement. Subjects were excluded if they underwent extraperitoneal colpopexy (ie, sacrospinous colpopexy) or any laparoscopic prolapse procedure. To account for all patients undergoing uterosacral colpopexy during the designated study period, subjects who were included in the published OPTIMAL and OPUS trials were also included in this study.


Once subjects were identified, the health system-wide electronic medical record was queried for demographic, intraoperative, and postoperative data. Adverse events included intraoperative events, events that occurred within the immediate 30-day postoperative period, and those that occurred within 12 months after the index surgery. All adverse events were identified via a manual chart review performed by 1 individual. Review of the chart included the detailed operative note as well as all postoperative visits and telephone calls leading up to the last day of follow-up. There is no consensus on what constitutes a clinically relevant adverse event, so we defined several adverse events a priori and classified participants using the Clavien-Dindo grading system. Ureteral kinking was defined as transient obstruction of the ureter, relieved with removal of suspension sutures at the time of the index procedure; and ureteral injury was defined as transection or injury of the ureter requiring urologic repair. Postoperative ureteral obstruction was defined as patients who were determined to have hydro-ureter or nephrosis on imaging, attributed to undiagnosed obstruction at the time of surgery. Urinary tract infection (UTI) was recorded if a patient developed an infection within 12 weeks of surgery. Culture-proven UTIs as well as symptomatic UTIs resulting in treatment without cultures obtained were recorded. All patients with suspected UTI were treated with oral antibiotics. In addition to analyzing adverse events independently, we classified a patient as developing a grade ≥3 complication using the above-mentioned Clavien-Dindo scale. A grade 3 complication is defined as a complication requiring surgical, endoscopic, or radiologic imaging/intervention (with or without anesthesia). A grade 4 complication is one that is considered life-threatening. Recurrent POP was defined using the following definitions: symptomatic vaginal bulge, any prolapse to or beyond the hymen, or any retreatment (reoperation or pessary) for POP. Data for POP recurrence were analyzed using a composite of these 3 definitions, meaning that subjects were classified as experiencing recurrent POP if they met any of the 3 defined criteria. Follow-up was recorded as the last visit a patient underwent a vaginal examination with the record noting presence or absence of vaginal vault prolapse and stage of prolapse if present. Patients were recorded as having vaginal bulge symptoms if they specifically reported the sensation of bulge in the vagina.


During the study time period, 6 surgeons performed uterosacral colpopexy for uterovaginal or posthysterectomy vaginal vault prolapse. Uterosacral colpopexy was performed using 3 techniques that differed based on surgeon suture choice and placement. Surgeon choice of technique was based solely on surgeon experience and preference during the study period, and was not related to patient characteristics such as extent of prolapse or previous POP surgery. In the first technique, a no. 0 polydioxanone and a no. 0 polypropylene suture were placed through the uterosacral ligament at the level of the ischial spine bilaterally for a total of 4 sutures (2 on each side, 1 permanent and 1 delayed-absorbable) ; in the second technique, 3 no. 0 polydioxanone sutures were placed through the uterosacral ligament at the level of ischial spine bilaterally for a total of 6 sutures (3 on each side, all delayed-absorbable). The third technique was a modified high McCall culdoplasty: a no. 0 polydioxanone suture was placed bilaterally through the uterosacral ligament at the level of the ischial spine, followed by placement of 1 McCall suture using no. 0 polypropylene, or 2 McCall sutures using no. 0 polydioxanone and no. 0 polypropylene. Concomitant procedures, besides vaginal hysterectomy, included salpingo-oophorectomy, cystocele repair, rectocele repair, anal sphincter repair, and midurethral sling placement.


The primary analysis looking at perioperative and postoperative adverse events was descriptive and statistics were reported for all groups as n/N (%) with 95% confidence intervals (CIs) for categorical variables and as mean ± SD and median (range) for all continuous variables. For the secondary analysis, comparisons of outcomes were performed using a Student t test for parametric continuous outcomes, the Mann Whitney U test for nonparametric outcomes, and a χ 2 test for all categorical outcomes. Associations between outcomes were measured using Pearson correlation. All tests were 2-sided and were considered significant at .05 level. Low event rates for most adverse events resulted in unstable logistic regression models, therefore, multivariate analyses were not possible for many adverse events reported. JMP 10.0 (SAS Institute Inc., Cary, NC) was used for all statistical analyses.




Results


In all, 1038 subjects were identified and 983 met study inclusion criteria. Concomitant procedures included the following: vaginal hysterectomy (88%), unilateral salpingo-oophorectomy (5.2%), bilateral salpingo-oophorectomy (9.8%), cystocele repair (80%), rectocele repair (58.1%), anal sphincter repair (1.1%), and midurethral sling placement (58.8%). Of subjects, 46.2% (454/983) underwent uterosacral ligament suspension with 2 sutures on each side (1 permanent and 1 delayed-absorbable), 36.7% (361/983) underwent suspension with 3 sutures on each side (all delayed-absorbable), and 17.2% (168/983) underwent a combined uterosacral and McCall suspension procedure. Subjects who underwent uterosacral colpopexy without hysterectomy (subjects with posthysterectomy vaginal vault prolapse) were more likely to undergo colpopexy with 2 sutures on each side (1 permanent and 1 delayed-absorbable), rather than 3 sutures (all delayed-absorbable) (90.5% vs 9.5%, P < .001). Mean case time (skin incision to closure) and median postoperative day of discharge for all cases were 146 (SD±46) minutes and 1 (range, 0–7) days, respectively. The median follow-up time for this cohort was 6.9 (range, 0.2–93.8) months.


Table 1 displays demographic data for all subjects. There were no statistical differences between those subjects who experienced an adverse event and those who did not. Table 2 displays the rates of perioperative and postoperative adverse events associated with uterosacral colpopexy at the time of vaginal hysterectomy. The overall adverse event rate was 31.2% (95% CI, 29.2–38.6), which included 20.3% (95% CI, 17.9–23.6) of subjects who were treated postoperatively for symptomatic UTI. The overall adverse event rate excluding UTI was 11.4% (95% CI, 10.1–14.4). Of subjects, 29.8% (95% CI, 27.3–33.4) experienced a Dindo grade 3 or 4 adverse event; however, 69.3% (203/293) of these events involved radiologic imaging only without intervention; and overall, the rate of complications requiring additional surgical intervention for management in the cohort was 3.5%. Additionally, the rate of adverse events attributed to preexisting comorbidities was 3.4%, and all remaining events were ascribed to the index surgical intervention. Vaginal hysterectomy, age, and operative time were not significantly associated with the overall complication rate or individual adverse events.



Table 1

Demographic data




















































Variable All subjects N = 983 No adverse event (n = 671) Any adverse event (n = 312) P value
Age, y, mean (±SD) 60 (11) 60 (11) 61 (11) .38
BMI, mean (±SD) 28.1 (5.2) 28.1 (5) 28.1 (5.4) .90
Vaginal parity, median [range] 3 [0–10] 3 [0–10] 3 [0–10] .64
POP stage, median [range] 3 [2–4] 3 [2–4] 3 [2–4] .78
Menopausal, % 82.2 82.6 81.9 .78
Tobacco use, % 7.5 7.5 7.5 .68
Previous POP surgery, % 6.8 6.4 7.2 .63

BMI , body mass index; POP , pelvic organ prolapse.

Unger. Adverse events after uterosacral colpopexy. Am J Obstet Gynecol 2015 .


Table 2

Perioperative and postoperative adverse events for all subjects, N = 983























































































































Variable Adverse event n/N % (95% CI)
Intraoperative events Bladder injury 10 1.0 (0.6–1.9)
Ureteral kinking 44 4.5 (3.4–6.0)
Ureteral injury 0
Bowel injury 1 0.1 (0.02–0.6)
Estimated blood loss >500 mL 14 1.4 (0.9–2.4)
Postoperative events Reoperation <30 d 5 0.5 (0.1–0.9)
Transfusion 16 1.6 (1.0–2.6)
Hematoma 24 2.4 (1.6–3.6)
Vaginal cuff cellulitis 15 1.5 (0.9–2.5)
Pelvic abscess 5 0.5 (0.2–1.2)
Ileus 1 0.1 (0.02–0.6)
Small bowel obstruction 8 0.8 (0.4–1.6)
Pulmonary 23 2.3 (1.6–3.5)
Cardiac 8 0.8 (0.4–1.6)
Deep vein thrombosis/pulmonary embolism 2 0.2 (0.06–0.7)
Neurologic injury 11 1.1 (0.6–2.0)
Postoperative ureteral injury/obstruction 5 0.5 (0.2–1.2)
Culture-proven urinary tract infection 200 20.3 (17.9–23.6)
Pyelonephritis 8 0.9 (0.5–1.8)
Any adverse event With culture-proven urinary tract infection 312 31.2 (29.2–38.6)
Without culture-proven urinary tract infection 112 11.4 (10.1–14.4)
Grade ≥3 Dindo complication a 293 29.8 (27.3–33.4)

Unger. Adverse events after uterosacral colpopexy. Am J Obstet Gynecol 2015 .

a Requiring surgical, endoscopic, or radiologic intervention.



Five subjects (0.5%; 95% CI, 0.1–0.8) required reoperation <30 days from their index surgery: 2 for management of a small bowel obstruction, 2 for management of postoperative ureteral obstruction, and 1 for management of voiding dysfunction after midurethral sling placement. The intraoperative bladder injury rate was 1% (95% CI, 0.6–1.9). There were no intraoperative ureteral injuries; however, 4.5% (95% CI, 3.4–6.0) of cases were complicated by ureteral kinking, all of which were resolved without subsequent sequelae with intraoperative suture removal with or without replacement of the vault suspension stitches. Suture type and number used on each side were not associated with the rate of ureteral kinking. The rate of postoperative ureteral obstruction was 0.5% (95% CI, 0.2–1.2) in spite of normal intraoperative cystoscopy with bilateral flow of indigo carmine (false-negative cystoscopy): 4 patients presented with postoperative flank pain, pelvic pain, fever, and/or lower urinary tract symptoms and were found on imaging to have hydroureter with or without hydronephrosis and required retrograde ureteral stenting; and 1 patient was asymptomatic but was incidentally found to have hydroureter on imaging, which resolved with expectant management. Uterosacral suspension technique was not associated with the rate of ureteral kinking or postoperative ureteral obstruction.


The rate of neurologic injury/neuropathic pain was 1.1% (95% CI, 0.6–2.0). The majority of injuries were localized to the femoral or sciatic nerve, resulting in a combination of pain, weakness, and sensory deficits. All patients were successfully treated with either expectant or conservative management and returned to baseline by 12 weeks. The rates of pulmonary and cardiac complications were 2.3% (95% CI, 1.6–3.5) and 0.8% (95% CI, 0.4–1.6), respectively. Subjects with chronic obstructive pulmonary disease (COPD) were more likely to experience postoperative pulmonary (23.0% vs 2.2%; adjusted odds ratio [adjOR], 14.8; 95% CI, 2.8–77.9; P ≤ .001) and cardiac (14.3% vs 0.7%; adjOR, 20.3; 95% CI, 2.2–191.2; P ≤ .001) complications. Similarly, subjects with cardiovascular disease were more likely to experience postoperative pulmonary (19.4% vs 0.5%; adjOR, 14.1; 95% CI, 5.3–37.6; P ≤ .001) and cardiac (11.1% vs 0.6%; adjOR, 34.5; 95% CI, 7.4–160.8; P ≤ .001) complications.


The rate of postoperative ileus and small bowel obstruction was 0.1% (95% CI, 0.02–0.6) and 0.8% (95% CI, 0.4–1.6), respectively. Known abdominal and pelvic adhesive disease (defined as known pelvic adhesions or a previous diagnosis of endometriosis) was associated with a higher likelihood of postoperative small bowel obstruction (7.7% vs 0.8%; P = .01; adjOR, 10.0; 95% CI, 1.2–88.5), whereas history of bowel disease (defined as diverticulitis, inflammatory bowel disease, or previous bowel surgery) was not significantly associated with ileus and/or small bowel obstruction. Postoperative UTI was not found to be significantly associated with any preoperative risk factors. Subjects with obstructive sleep apnea (OSA) were more likely to experience any adverse event (adjOR, 7.2; 95% CI, 2.0–45.5; P < .001). The following variables were associated with any adverse event after excluding UTI: OSA (adjOR, 3.3; 95% CI, 1.3–8.2; P = .008), cardiovascular disease (adjOR, 3.0; 95% CI, 1.5–5.9; P < .001), and concomitant midurethral sling placement (adjOR, 1.4; 95% CI, 1.1–2.0; P = .02).


The composite recurrent POP rate over the 6.9-month median follow-up period was 14.4% (95% CI, 12.4–16.8) with 10.6% (95% CI, 8.8–12.7) experiencing vaginal bulge symptoms, 11% (95% CI, 9.2–13.1) with prolapse at or beyond the hymen, and 3.4% (95% CI, 2.4–4.7) requiring retreatment for POP with either reoperation or the use of a pessary. Of subjects who reported bulge symptoms, 70/104 (67.3%) were noted to have prolapse at or beyond the hymen on examination. Recurrence was distributed over the 3 compartments: 55% anterior, 33.9% posterior, and 15.1% apical with or without anterior and/or posterior prolapse. Using all definitions for recurrence, preoperative pelvic organ prolapse quantification (POP-Q) stage was not associated with POP recurrence. Number of sutures used at the time of colpopexy was also not associated with a higher rate of composite recurrence: 12.5% (95% CI, 8.3–18.4) with the 2 high uterosacral sutures and McCall technique, 14.8% (95% CI, 12–18.1) with 4 sutures placed, and 14.1% (95% CI, 11.2–17.7) with 6 sutures placed; P =.74. Similarly, type of suture placed (combination delayed-absorbable and permanent vs delayed-absorbable only) was not associated with composite recurrence. Of the 4.5% (44/983) of subjects who required unilateral removal of colpopexy sutures to resolve ureteral kinking, 63.6% (28/44) did not undergo replacement of these sutures, resulting in a unilateral suspension. There was no difference in composite recurrent POP in patients who underwent suture replacement after unilateral ureteral kinking (11.1%; 95% CI, 9.2–15.8) and those who did not have sutures replaced (14.5%; 95% CI, 12.5–16.9), P = .68. The overall rate of granulation tissue was 10.7% (95% CI, 8.9–12.8); there was no difference in the rate of granulation tissue found in patients who underwent colpopexy with delayed-absorbable and permanent suture (10.7%; 95% CI, 8.7–13.1) and those who had delayed-absorbable suture only placed (10.2%; 95% CI, 6.8–15.2), P = .19. Suture erosion and need for suture removal in the office was more common in patients who had permanent suture placed compared to delayed-absorbable only, but this difference was not statistically significant: 6.2% (95% CI, 4.7–8.1) vs 2.4% (95% CI, 1–5.6), P = .10.

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May 6, 2017 | Posted by in GYNECOLOGY | Comments Off on Incidence of adverse events after uterosacral colpopexy for uterovaginal and posthysterectomy vault prolapse

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