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NCT04263896 · ClinicalTrials.gov registry record · Phase 4
Bowel Function After Minimally Invasive Hysterectomy
A Phase 4 study, sponsored by University of Chicago.
- Completed
- Registry status
- Phase 4
- Development phase
- 97
- Enrollment target
NCT04263896: Completed Phase 4 study, sponsored by University of Chicago.
NCT04263896 is a Phase 4 study that has completed, run by University of Chicago. The registered enrollment target is 97 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04263896, a Phase 4 study, has completed, sponsored by University of Chicago.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 97 participants
- Enrollment target
Study Summary
Postoperative constipation affects up to a third of women undergoing minimally invasive (MIS) gynecologic surgery and is a major source of anxiety and discomfort. The average time to first bowel movement after gynecologic surgery is about 2 to 4 days and some factors responsible for this include anesthesia inhibitory effect on gastrointestinal motility, opioid pain medication use, chronic nonsteroidal anti-inflammatory drugs (NSAID) use and anatomic manipulation. There are no established regimens to manage postoperative constipation after minimally invasive gynecologic surgery. Two studies evaluating the implementation of postoperative bowel regimen with polyethylene glycol (PEG) and with Senna and Docusate found no significant impact on postoperative bowel function. There have been no studies looking at the effect of preoperative bowel regimens on postoperative bowel function. The purpose of this study is to evaluate postoperative bowel function after minimally invasive hysterectomy in women receiving a preoperative 10-day bowel regimen of PEG daily.
Primary Outcome
Constipation will be evaluated both preoperatively and postoperatively using a validated questionnaires (PAC-SYM/PAC-QOL). Patient assessment of constipation symptoms (PAC-SYM) - The Patient Assessment of Constipation-Symptoms (PAC-SYM) questionnaire, developed through psychometric evaluation of adults with chronic constipation, is a tool for assessing the severity of patient-reported symptoms of this disorder. The 12-item questionnaire is divided into three symptom subscales: abdominal (four it
Interventions
- DRUG Polyethylene Glycol 3350
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 97 participants |
| Start Date | 2019-08-28 |
| Est. Completion | 2025-06-09 |
| Phase | Phase 4 |
What the finished NCT04263896 record still lists
NCT04263896 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 97 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 1 intervention - of which Polyethylene Glycol 3350 is the first listed.
NCT04263896 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04263896 about?
NCT04263896 is a clinical study titled "Bowel Function After Minimally Invasive Hysterectomy". Postoperative constipation affects up to a third of women undergoing minimally invasive (MIS) gynecologic surgery and is a major source of anxiety and discomfort. The average time to first bowel movement after gynecologic surgery is about 2 to 4 days and some factors responsible for this include ane...
What is the current status of trial NCT04263896?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 97 participants. The study started on 2019-08-28. Estimated completion is 2025-06-09.
What interventions are being tested in trial NCT04263896?
The interventions under investigation include: Polyethylene Glycol 3350 (DRUG).
Who is sponsoring clinical trial NCT04263896?
This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04263896's enrollment target sits among peer trials
97 861st of 2000 higher than 1,138 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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