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NCT01431040 · ClinicalTrials.gov registry record · NA
Patient Experience and Bowel Preparation for Transvaginal Surgical Management of Vaginal Prolapse
A NA study, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- NA
- Development phase
- 150
- Enrollment target
NCT01431040 is a NA study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 150 participants.
The verdict
NCT01431040, a NA study, has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- NA
- Development phase
- 150 participants
- Enrollment target
Study Summary
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 re
Interventions
- OTHER No bowel prep
- OTHER Clear liquid diet and 2 Fleet's enemas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2011-01 |
| Est. Completion | 2013-08 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01431040
The ClinicalTrials.gov registry entry for NCT01431040 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which No bowel prep is the first listed.
NCT01431040 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01431040 about?
NCT01431040 is a clinical study titled "Patient Experience and Bowel Preparation for Transvaginal Surgical Management of Vaginal Prolapse". 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...
What is the current status of trial NCT01431040?
This trial is currently completed. It is a NA study. The enrollment target is 150 participants. The study started on 2011-01. Estimated completion is 2013-08.
What interventions are being tested in trial NCT01431040?
The interventions under investigation include: No bowel prep (OTHER), Clear liquid diet and 2 Fleet's enemas (OTHER).
Who is sponsoring clinical trial NCT01431040?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
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