Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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: Completed NA study, sponsored by University of Alabama at Birmingham.

NCT01431040 is a NA study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 150 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

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

Primary Outcome

The primary outcome measure will be measured using the surgeon satisfaction questionnaire which is filled out immediately post-op. The surgeon assessment of the bowel preparation and its potential outcome on the surgical field (adequate visualization, stooling during case, and difficulty with bowel handling) will be measured.

Interventions

  • OTHER No bowel prep
  • OTHER Clear liquid diet and 2 Fleet's enemas

Trial Details

FieldValue
Enrollment Target 150 participants
Start Date 2011-01
Est. Completion 2013-08
Phase NA
University of Alabama at Birmingham

1,160 total trials

What the finished NCT01431040 record still lists

NCT01431040 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower).

The record links to 0 conditions, and to 2 interventions - of which No bowel prep is the first listed.

NCT01431040 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT01431040's enrollment target sits among peer trials

150 661st of 2000 higher than 1,299 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT00412594 · 150 participants · Phase 2

    Cladribine and Rituximab in Treating Patients With Hairy Cell Leukemia

  • NCT01484730 · 150 participants

    A Pilot Study to Evaluate Multi-Spectral and Laser Speckle Imaging and Multiphoton Microscopy During Vascular Occlusion

  • NCT01985919 · 150 participants

    Protocol for Facilitating the Acquisition of Research Bone Marrow and Blood Samples

  • NCT02016248 · 150 participants · NA

    SBRT Boost for Unfavorable Prostate Cancer'

Similar registry start date

  • NCT05988463 · started 2027-01-01 · Phase 1

    Dose-Escalation Study of Artesunate Patients With IPF

  • NCT07219706 · started 2026-12-10 · NA

    Dietary Fiber and Time Restricted Eating

  • NCT02831335 · started 2026-12-01

    Technical Development of Multi-Parametric Renocerebral MRI

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

Source: ClinicalTrials.gov NCT01431040, the US trial registry maintained by the National Library of Medicine. NCT01431040 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.