Patient Experience and Bowel Preparation for Transvaginal Surgical Management of Vaginal Prolapse

Completed · Not applicable

Conditions studied: Value of the Bowel Preparation and Diet Change Versus no Intervention, Preoperative Bowel Regimen

In brief

Preoperative bowel preparation for surgical management of pelvic floor disorders is performed inconsistently, and includes no prep, the use of dietary changes or bowel altering interventions. Retrospective studies of emergency colonic surgery first demonstrated a low rate of infectious complications without a bowel prep. Recently, data supporting the routine use of mechanical cleansing for elective colorectal surgery has demonstrated the surgical outcomes are similar between patients that undergo a bowel preparation versus those that do not, indicating that the long held dogma of mechanical bowel preparation should be used selectively. Despite routine use, there is a paucity of literature addressing the approach to, and/or need for preoperative bowel management at the time of vaginal reconstructive or obliterative surgery. The majority of the pelvic floor disorder population is older, tending to have more bowel dysfunction (especially symptoms of constipation) than younger women. The aim of this study is to evaluate preoperative bowel management strategy as it relates to the total care of the vaginal surgery patients' intra-and post-operative bowel function and overall patient experience. Two commonly used pre-operative bowel prep strategies: no preoperative bowel prep versus clear fluids and 2-enema prep. The aim is to assess the value of bowel preparation or diet change in vaginal surgery, both from the physician's and patient's point of view. In this pilot study, subjects are randomized to either a clear liquid diet the day prior to surgery with 2 enemas and nothing by mouth (NPO) after midnight, or NPO after midnight without any dietary changes or enemas. Our aims are: \*Primary - To assess the surgeons' objective intraoperative evaluation of the effects of bowel preparation (adequate visualization, stooling during case, difficulty with bowel handling) \*Secondary - (1)To characterize the patients' experience and acceptance of preoperative bowel management regimen versus no preoperative bowel preparation(2) To characterize the patients' postoperative experience and determine if the preoperative bowel regimen affects time to first bowel movement/first normal stool as well as stool experience as recorded by bowel diary (3)Evaluate the incidence of complications between the two groups (4)Characterize other descriptive qualities of the patients' operative experience(duration of case, length of hospital stay)

Key facts

Study ID: NCT01431040
Run by: University of Alabama at Birmingham
People needed: 150
Starts: 2011-01-01
Expected to finish: 2013-08-01
Last updated by the study team: 2014-06-16

Who can join

Age: 19 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

Age ≥ 19
Female
Undergoing transvaginal reconstructive surgical intervention for vaginal prolapse (apical suspension and posterior compartment repair required, other concurrent surgery allowed)

You may not qualify if…

Male
Pregnant, planning pregnancy, or less than 1 year from delivery
History of total colectomy or prior ileostomy
Inflammatory bowel disorder (Crohn's disease and ulcerative colitis) formally diagnosed
Inability to understand written study material (including non-English speaking)
Inability to give consent
Presently diagnosed colorectal cancer
Undergoing chemotherapy and/or radiation
Chronic constipation suggestive of colonic inertia defined as fewer that 3 stools per week (Rome III guidelines)
Severe neurological diseases (such as Multiple Sclerosis)

Where it is running

University of Alabama at Birmingham, The Kirklin Clinic — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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