Dataset Information

Readmission and Prolapse Recurrence After Abdominal and Vaginal Apical Suspensions in Older Women.

ABSTRACT: Our objective was to evaluate 30-day readmission, 12-month prolapse recurrence, and complications after apical surgeries in older women.A retrospective cohort study was conducted using 2002-2011 Medicare data in women 65 years or older who underwent abdominal sacrocolpopexy with synthetic mesh, vaginal uterosacral, or sacrospinous colpopexy with 12 months follow-up. Vaginal mesh procedures were excluded. The primary outcome was 30-day inpatient readmission. Secondary outcomes were complications and prolapse recurrence, defined as either reoperation or pessary insertion. We used Pearson ?, Fisher exact tests, and analyses of variance to examine difference between surgical treatment groups. Odds ratios (ORs) utilizing Charlson Comorbidity Index, age, race, and procedure type were calculated to assess the differences in the outcomes probability.Of 3,015 women, 863 underwent abdominal sacrocolpopexy, 510-uterosacral and 1,642-sacrospinous ligament suspensions. The 30-day readmission was 7.4% (95% confidence interval [CI] 5.7-9.2%; OR 2.4, 95% CI 1.7-3.5, P<.01) after abdominal sacrocolpopexy and 4.5% (95% CI 2.7-6.3%; OR 1.3, 95% CI 0.8-2.1, P=.3) after uterosacral compared with 3.5% (95% CI 2.6-4.4% P<.01) after sacrospinous ligament suspensions. Prolapse recurrence did not differ between the groups (8.2%, 95% CI 6.4-10.1%; 10.6%, 95% CI 7.9-13.3%; and 9.9%, 95% CI 8.4-11.3%, P=.3, respectively). Women had 30-day gastrointestinal complications (6.1%, 95% CI 4.5-7.7%; 1.2%, 95% CI 0.2-2.1%; and 1.1%, 95% CI 0.6-1.6%, P<.01), surgical site infections (5.9%, 95% CI 4.3-7.5%; 3.1%, 95% CI 1.6-4.7%; and 3.7%, 95% CI 2.8-4.6%, P=.01), genitourinary complications (10.9%, 95% CI 8.8-13%; 17.7%, 95% CI 14.3-21%; and 13.6%, 95% CI 12-15.3%, P<.01), and medical complications (7.4%, 95% CI 5.7-9.2%; 7.8%, 95% CI 5.5-10.2%; and 4.4%, 95% CI 3.4-5.4%, P<.01; all after abdominal sacrocolpopexy, uterosacral, and sacrospinous ligament suspensions, respectively).Vaginal apical suspensions compared with abdominal sacrocolpopexy with synthetic mesh are associated with lower rates of postoperative 30-day readmission without an increase in prolapse recurrence among older women.

SUBMITTER: Sanses TV

PROVIDER: S-EPMC5121077 | biostudies-literature | 2016 Dec

REPOSITORIES: biostudies-literature

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Readmission and Prolapse Recurrence After Abdominal and Vaginal Apical Suspensions in Older Women.

Sanses Tatiana V D TVD Hanley Jan M JM Zhang Peter P Richter Holly E HE Gambert Steven R SR Saigal Chris S CS

Obstetrics and gynecology 20161201 6

<h4>Objective</h4>Our objective was to evaluate 30-day readmission, 12-month prolapse recurrence, and complications after apical surgeries in older women.<h4>Methods</h4>A retrospective cohort study was conducted using 2002-2011 Medicare data in women 65 years or older who underwent abdominal sacrocolpopexy with synthetic mesh, vaginal uterosacral, or sacrospinous colpopexy with 12 months follow-up. Vaginal mesh procedures were excluded. The primary outcome was 30-day inpatient readmission. Seco ...[more]

PMID: 27824746

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Project description:More than 300,000 surgeries are performed annually in the United States for pelvic organ prolapse. Sacrospinous ligament fixation (SSLF) and uterosacral ligament suspension (ULS) are commonly performed transvaginal surgeries to correct apical prolapse. Little is known about their comparative efficacy and safety, and it is unknown whether perioperative behavioral therapy with pelvic floor muscle training (BPMT) improves outcomes of prolapse surgery.To compare outcomes between (1) SSLF and ULS and (2) perioperative BPMT and usual care in women undergoing surgery for vaginal prolapse and stress urinary incontinence.Multicenter, 2?×?2 factorial, randomized trial of 374 women undergoing surgery to treat both apical vaginal prolapse and stress urinary incontinence was conducted between 2008 and 2013 at 9 US medical centers. Two-year follow-up rate was 84.5%.The surgical intervention was transvaginal surgery including midurethral sling with randomization to SSLF (n?=?186) or ULS (n?=?188); the behavioral intervention was randomization to receive perioperative BPMT (n?=?186) or usual care (n?=?188).The primary outcome for the surgical intervention (surgical success) was defined as (1) no apical descent greater than one-third into vaginal canal or anterior or posterior vaginal wall beyond the hymen (anatomic success), (2) no bothersome vaginal bulge symptoms, and (3) no re-treatment for prolapse at 2 years. For the behavioral intervention, primary outcome at 6 months was urinary symptom scores (Urinary Distress Inventory; range 0-300, higher scores worse), and primary outcomes at 2 years were prolapse symptom scores (Pelvic Organ Prolapse Distress Inventory; range 0-300, higher scores worse) and anatomic success.At 2 years, surgical group was not significantly associated with surgical success rates (ULS, 59.2% [93/157] vs SSLF, 60.5% [92/152]; unadjusted difference, -1.3%; 95% CI, -12.2% to 9.6%; adjusted odds ratio [OR], 0.9; 95% CI, 0.6 to 1.5) or serious adverse event rates (ULS, 16.5% [31/188] vs SSLF, 16.7% [31/186]; unadjusted difference, -0.2%; 95% CI, -7.7% to 7.4%; adjusted OR, 0.9; 95% CI, 0.5 to 1.6). Perioperative BPMT was not associated with greater improvements in urinary scores at 6 months (adjusted treatment difference, -6.7; 95% CI, -19.7 to 6.2), prolapse scores at 24 months (adjusted treatment difference, -8.0; 95% CI, -22.1 to 6.1), or anatomic success at 24 months.Two years after vaginal surgery for prolapse and stress urinary incontinence, neither ULS nor SSLF was significantly superior to the other for anatomic, functional, or adverse event outcomes. Perioperative BPMT did not improve urinary symptoms at 6 months or prolapse outcomes at 2 years.clinicaltrials.gov Identifier: NCT00597935.

Project description:Introduction and hypothesisFollowing health notification by the FDA in 2008 of serious complications with transvaginal mesh for anterior pelvic organ prolapse, there has been a return to native tissue repairs. Earlier work with a self-retaining support (SRS) implant showed a high anatomical success rate with minimal implant-related complications over a medium-term follow-up. It is proposed that post-implant complications are more a consequence of the method of mesh anchoring rather than the implant itself. Our system incorporates an ultralight mesh with a frame that provides level I, II, and III support without the need for fixation. The first long-term outcomes of SRS implantation are presented.MethodsA prospective multicenter trial was conducted using two consecutive identical protocols of the use of the SRS implant in women with symptomatic anterior compartment prolapse extending their follow-up to 36 months. Anatomical success (Pelvic Organ Prolapse Quantification stage 0 or 1 or a Ba ≤ -2) was recorded along with subjective success as defined by regular quality-of-life (PFDI-20 and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire) assessments.ResultsSixty-seven patients completed 36 months of follow-up. Mean Ba measurements improved from 3.1 (-1 to 6) cm to -2.8 (-1 to -3) cm and C point from 0.4 (-8 to 6) cm to -6.9 (-10 cm to 1) cm. accumulating to a significant anatomical success rate of 94.3%. Subjective success based on question #3 of the PFDI-20, analyzed for the index surgical compartment, reached 95.7%. Post-operative complications included 2 cases of urinary retention, 1 minor frame exposure, 1 case of delayed voiding dysfunction, and 2 cases of de novo stress urinary incontinence. Untreated pre-operative second-degree Bp measurements had increased in 27% at follow-up.ConclusionThe long-term outcome of the SRS implant shows an excellent subjective and objective success with minimal risk of complications or need for reintervention.

Dataset Information

Readmission and Prolapse Recurrence After Abdominal and Vaginal Apical Suspensions in Older Women.

Publications

Readmission and Prolapse Recurrence After Abdominal and Vaginal Apical Suspensions in Older Women.

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