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.
Bowel preparation for prolapse surgery demonstrates no advantage over a regular diet regarding surgeons' assessment of the surgical field, has decreased patient satisfaction, and has increased abdominal symptoms.
Division of Urogynecology and Pelvic Reconstructive Surgery, Department of Obstetrics and Gynecology, the Department of Medicine, Division of Gerontology, Geriatrics, and Palliative Care, and the Center for Clinical and Translational Science, University of Alabama at Birmingham, and the Birmingham/Atlanta Geriatric Research, Education, and Clinical Center, Department of Veterans Affairs, Birmingham, Alabama.
Corresponding author: Holly E. Richter, PhD, MD, Division of Urogynecology and Pelvic Reconstructive Surgery, Department of Obstetrics and Gynecology, University of Alabama at Birmingham, 619 19th Street South, 176-F, Suite 10382, Birmingham, AL, 35249; e-mail: firstname.lastname@example.org.
Supported in part by the UAB Center for Clinical and Translational Science Grant Number UL1TR000165 from the National Center for Advancing Translational Sciences (NCATS) and National Center for Research Resources (NCRR) component of the National Institutes of Health (NIH). Also partially funded by 2K24-DK068389 to Holly E. Richter from the National Institute of Diabetes and Digestive and Kidney Disease, NIH.
The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.
The authors thank W. Jerod Greer, MD, Robert L. Holley, MD, and Kathy Carter, RN, in the Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, Alabama, for their help in recruitment of participants as well as Gerald McGwin Jr, PhD, Center for Clinical and Translational Science, University of Alabama at Birmingham, Birmingham, Alabama, for his statistical support.
Presented at the 39th Annual Society for Gynecological Surgeon's Meeting, April 8–10, 2013, Charleston, South Carolina.
Financial Disclosure Dr. Richter has received research grants from Astellas, Pelvalon, and the University of California San Francisco/Pfizer. She has served as a consultant for Pelvalon and Astellas. The other authors did not report any potential conflicts of interest.