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NCT01805310 · ClinicalTrials.gov registry record · Phase 4
Pre-operative Bowel Preparation Prior to Minimally Invasive Sacral Colpopexy
A Phase 4 study, sponsored by Halina M Zyczynski, MD.
- Completed
- Registry status
- Phase 4
- Development phase
- 95
- Enrollment target
NCT01805310: Completed Phase 4 study, sponsored by Halina M Zyczynski, MD.
NCT01805310 is a Phase 4 study that has completed, run by Halina M Zyczynski, MD. The registered enrollment target is 95 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01805310, a Phase 4 study, has completed, sponsored by Halina M Zyczynski, MD.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 95 participants
- Enrollment target
Study Summary
Prior to surgery, gynecologists and urogynecologists have routinely prescribed preoperative mechanical bowel preparations in attempts to decrease the risk of infection, while also providing easier bowel manipulation and better visualization during surgery. However, many of these proposed benefits have never been proven, and usage of bowel preparations amongst surgeons remains highly variable. In both the general surgery and gynecology literature, researchers have begun to question the need for the vigorous preparations. Aside from surgical visualization, urogynecologists have additional concerns about how bowel preparations may impact postoperative bowel function given up to half of women with pelvic floor disorders have baseline constipation and straining is known to impact surgical recovery. Many studies have addressed various postoperative fiber and laxative preparations in attempts to improve postoperative bowel-related symptomatology, but none have specifically looked at preoperative bowel preparations. This study aims to determine if mechanical bowel preparation prior to minimally invasive sacral colpopexy affects patients' postoperative recovery, specifically related to bowel symptomatology; operative or post-operative complications; surgeons' perceptions of surgical difficulty directly attributed to the bowel; and post-operative return of normal bowel function.
Primary Outcome
Bowel symptomatology and bowel-related discomfort will be assessed with the Patient Assessment of Constipation Symptom Questionnaire (PAC-SYM), a 12-item questionnaire covering three domains: abdominal, rectal, and stool.
Interventions
- OTHER No bowel preparation
- OTHER Bowel preparation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 95 participants |
| Start Date | 2013-02 |
| Est. Completion | 2017-08 |
| Phase | Phase 4 |
What the finished NCT01805310 record still lists
NCT01805310 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 95 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 2 interventions - of which No bowel preparation is the first listed.
NCT01805310 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01805310 about?
NCT01805310 is a clinical study titled "Pre-operative Bowel Preparation Prior to Minimally Invasive Sacral Colpopexy". Prior to surgery, gynecologists and urogynecologists have routinely prescribed preoperative mechanical bowel preparations in attempts to decrease the risk of infection, while also providing easier bowel manipulation and better visualization during surgery. However, many of these proposed benefits ha...
What is the current status of trial NCT01805310?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 95 participants. The study started on 2013-02. Estimated completion is 2017-08.
What interventions are being tested in trial NCT01805310?
The interventions under investigation include: No bowel preparation (OTHER), Bowel preparation (OTHER).
Who is sponsoring clinical trial NCT01805310?
This trial is sponsored by Halina M Zyczynski, MD, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01805310's enrollment target sits among peer trials
95 869th of 2000 higher than 1,130 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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
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