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Bowel preparation before vaginal prolapse surgery: a randomized controlled trial.

ABSTRACT: To compare surgeons' intraoperative surgeon acceptability or assessment of the operative field regarding bowel contents and patients' satisfaction with or without a mechanical bowel preparation before reconstructive vaginal prolapse surgery.In this single-blind, randomized trial, women scheduled to undergo vaginal prolapse surgery with a planned apical suspension and posterior colporrhaphy were allocated using block randomization to an intervention or control group. Surgeons were blinded to patient allocation. One day before surgery, mechanical bowel preparation instructions consisted of a clear liquid diet and two self-administered saline enemas; the participants in the control group sustained a regular diet and nothing by mouth after midnight. The primary outcome was surgeons' intraoperative assessment of the surgical field regarding bowel content as measured on a 4-point Likert scale (1, excellent; 4, poor). Secondary outcomes included participant satisfaction and bowel symptoms. The primary outcome was determined by intention-to-treat analysis and other analyses were per protocol.Of the 150 women randomized (75 women to intervention and control group), 145 completed the study. No differences existed in the demographic, clinical, and intraoperative characteristics between groups (P>.05). Surgeons' intraoperative assessment rating was 85% "excellent or good" with bowel preparation compared with 90% for participants in the control group (odds ratio [OR] 0.59, 95% confidence interval [CI] 0.21-1.61; P=.30). The bowel preparation group was less likely to report "complete" satisfaction compared with the participants in the control group (OR 0.11, 95% CI 0.04-0.35; P<.001). Abdominal fullness and cramping, fatigue, anal irritation, and hunger pains were greater in the bowel preparation group (all P<.01).Before reconstructive vaginal surgery, mechanical bowel preparation conferred no benefit regarding surgeons' intraoperative assessment of the operative field, reflected decreased patient satisfaction, and had increased abdominal symptoms.ClinicalTrials.gov, www.clinicaltrials.gov, NCT01431040.I.

SUBMITTER: Ballard AC

PROVIDER: S-EPMC3909883 | biostudies-literature | 2014 Feb

REPOSITORIES: biostudies-literature

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Bowel preparation before vaginal prolapse surgery: a randomized controlled trial.

Ballard Alicia C AC Parker-Autry Candace Y CY Markland Alayne D AD Varner R Edward RE Huisingh Carrie C Richter Holly E HE

Obstetrics and gynecology 20140201 2 Pt 1

<h4>Objective</h4>To compare surgeons' intraoperative surgeon acceptability or assessment of the operative field regarding bowel contents and patients' satisfaction with or without a mechanical bowel preparation before reconstructive vaginal prolapse surgery.<h4>Methods</h4>In this single-blind, randomized trial, women scheduled to undergo vaginal prolapse surgery with a planned apical suspension and posterior colporrhaphy were allocated using block randomization to an intervention or control gr ...[more]

PMID: 24402594

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Project description:ImportanceSurgical repairs of apical/uterovaginal prolapse are commonly performed using native tissue pelvic ligaments as the point of attachment for the vaginal cuff after a hysterectomy. Clinicians may recommend vaginal estrogen in an effort to reduce prolapse recurrence, but the effects of intravaginal estrogen on surgical prolapse management are uncertain.ObjectiveTo compare the efficacy of perioperative vaginal estrogen vs placebo cream on prolapse recurrence following native tissue surgical prolapse repair.Design, setting, and participantsThis randomized superiority clinical trial was conducted at 3 tertiary US clinical sites (Texas, Alabama, Rhode Island). Postmenopausal women (N = 206) with bothersome anterior and apical vaginal prolapse interested in surgical repair were enrolled in urogynecology clinics between December 2016 and February 2020.InterventionsThe intervention was 1 g of conjugated estrogen cream (0.625 mg/g) or placebo, inserted vaginally nightly for 2 weeks and then twice weekly to complete at least 5 weeks of application preoperatively; this continued twice weekly for 12 months postoperatively. Participants underwent a vaginal hysterectomy (if uterus present) and standardized apical fixation (either uterosacral or sacrospinous ligament fixation).Main outcomes and measuresThe primary outcome was time to failure of prolapse repair by 12 months after surgery defined by at least 1 of the following 3 outcomes: anatomical/objective prolapse of the anterior or posterior walls beyond the hymen or the apex descending more than one-third of the vaginal length, subjective vaginal bulge symptoms, or repeated prolapse treatment. Secondary outcomes included measures of urinary and sexual function, symptoms and signs of urogenital atrophy, and adverse events.ResultsOf 206 postmenopausal women, 199 were randomized and 186 underwent surgery. The mean (SD) age of participants was 65 (6.7) years. The primary outcome was not significantly different for women receiving vaginal estrogen vs placebo through 12 months: 12-month failure incidence of 19% (n = 20) for vaginal estrogen vs 9% (n = 10) for placebo (adjusted hazard ratio, 1.97 [95% CI, 0.92-4.22]), with the anatomic recurrence component being most common, rather than vaginal bulge symptoms or prolapse repeated treatment. Masked surgeon assessment of vaginal tissue quality and estrogenization was significantly better in the vaginal estrogen group at the time of the operation. In the subset of participants with at least moderately bothersome vaginal atrophy symptoms at baseline (n = 109), the vaginal atrophy score for most bothersome symptom was significantly better at 12 months with vaginal estrogen.Conclusions and relevanceAdjunctive perioperative vaginal estrogen application did not improve surgical success rates after native tissue transvaginal prolapse repair.Trial registrationClinicalTrials.gov Identifier: NCT02431897.

Project description:BackgroundAdequate bowel preparation is essential for the visualization of the colonic mucosa during colonoscopy. However, the rate of inadequate bowel preparation is still high, ranging from 18% to 35%; this may lead to a higher risk of missing clinically relevant lesions, procedural difficulties, prolonged procedural time, an increased number of interval colorectal carcinomas, and additional health care costs.ObjectiveThe aims of this study are to compare bowel preparation instructions provided via a personalized smartphone app (Prepit, Ferring B V) with regular written instructions for bowel preparation to improve bowel preparation quality and to evaluate patient satisfaction with the bowel preparation procedure.MethodsEligible patients scheduled for an outpatient colonoscopy were randomized to a smartphone app group or a control group. Both the groups received identical face-to-face education from a research physician, including instructions about the colonoscopy procedure, diet restrictions, and laxative intake. In addition, the control group received written information, whereas the smartphone app group was instructed to use the smartphone app instead of the written information for the actual steps of the bowel preparation schedule. All patients used bisacodyl and sodium picosulfate with magnesium citrate as laxatives. The quality of bowel preparation was scored using the Boston Bowel Preparation Scale (BBPS) by blinded endoscopists. Patient satisfaction was measured using the Patient Satisfaction Questionnaire-18.ResultsA total of 87 patients were included in the smartphone app group and 86 in the control group. The mean total BBPS score was significantly higher in the smartphone app group (mean 8.3, SD 0.9) than in the control group (mean 7.9, SD 1.2; P=.03). The right colon showed a significantly higher bowel preparation score in the smartphone app group (mean 2.7, SD 0.5 vs mean 2.5, SD 0.6; P=.04). No significant differences were observed in segment scores for the mean transverse colon (mean 2.8, SD 0.4 vs mean 2.8, SD 0.4; P=.34) and left colon (mean 2.8, SD 0.4 vs mean 2.6, SD 0.5; P=.07). General patient satisfaction was high for the smartphone app group (mean 4.4, SD 0.7) but showed no significant difference when compared with the control group (mean 4.3, SD 0.8; P=.32).ConclusionsOur personalized smartphone app significantly improved bowel preparation quality compared with regular written instructions for bowel preparation. In particular, in the right colon, the BBPS score improved, which is of clinical relevance because the right colon is considered more difficult to clean and the polyp detection rate in the right colon improves with improvement of bowel cleansing of the right colon. No further improvement in patient satisfaction was observed compared with patients receiving regular written instructions.Trial registrationClinicalTrials.gov NCT03677050; https://clinicaltrials.gov/ct2/show/NCT03677050.

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Bowel preparation before vaginal prolapse surgery: a randomized controlled trial.

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Bowel preparation before vaginal prolapse surgery: a randomized controlled trial.

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