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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 is a Phase 4 study that has completed, run by University of Chicago. The registered enrollment target is 97 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04263896
The ClinicalTrials.gov registry entry for NCT04263896 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 97 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Chicago, which has 796 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Polyethylene Glycol 3350 is the first listed.
NCT04263896 reports 0 study locations.
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.
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