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NCT03800745 · ClinicalTrials.gov registry record · Phase 4
Reduction of Postoperative Gastrointestinal Dysmotility Following Total Laparoscopic Hysterectomy.
A Phase 4 study of Postoperative Passage of Flatus and Postoperative Bowel Movement, sponsored by The Cleveland Clinic.
- Completed
- Registry status
- Phase 4
- Development phase
- 81
- Enrollment target
- 1
- Study location
NCT03800745: Completed Phase 4 study of Postoperative Passage of Flatus and Postoperative Bowel Movement, sponsored by The Cleveland Clinic.
NCT03800745 is a Phase 4 study of Postoperative Passage of Flatus and Postoperative Bowel Movement that has completed, run by The Cleveland Clinic. The registered enrollment target is 81 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03800745, a Phase 4 study of Postoperative Passage of Flatus and Postoperative Bowel Movement, has completed, sponsored by The Cleveland Clinic.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 81 participants
- Enrollment target
- 1
- Study location
Study Summary
Return of bowel function is an integral component of postoperative recovery following minimally invasive gynecologic surgery. To date, there is no standardized regimen to optimize bowel motility postoperatively. Clinical practices vary in the medications prescribed to facilitate this process, as well as what is considered the norm for return of flatus and time to first bowel movement. This study is a randomized control trial. The primary outcome of the study is to assess the effect of a standardized postoperative bowel care regimen on return of bowel function by assessing the time to first bowel movement; a secondary outcome is to assess the effect of such a regimen on time to first flatus. The hypothesis is that the prescription of a laxative, rather than a stool softener or no agent, will expedite the time to first bowel movement and first flatus. Other secondary outcomes and endpoints are assessing narcotic use measured in total oral morphine equivalents in the first five days postoperatively, as well as the constipation score and the PAC-SYM questionnaire.
Primary Outcome
The primary outcome of the study is to assess the effect of a standardized postoperative bowel care regimen on return of bowel function by assessing the date and time of first BM after surgery.
Conditions Studied
Interventions
- DRUG Colace 100Mg Capsule
- DRUG Miralax
Study Locations (1)
Florida
- Cleveland Clinic Florida - Weston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2018-11-09 |
| Est. Completion | 2020-05-05 |
| Phase | Phase 4 |
What the finished NCT03800745 record still lists
NCT03800745 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 81 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (84% lower).
The record links to 2 conditions, with Postoperative Passage of Flatus appearing as the primary indexed condition, and to 2 interventions - of which Colace 100Mg Capsule is the first listed.
NCT03800745 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT03800745 about?
NCT03800745 is a clinical study titled "Reduction of Postoperative Gastrointestinal Dysmotility Following Total Laparoscopic Hysterectomy.". Return of bowel function is an integral component of postoperative recovery following minimally invasive gynecologic surgery. To date, there is no standardized regimen to optimize bowel motility postoperatively. Clinical practices vary in the medications prescribed to facilitate this process, as wel...
What is the current status of trial NCT03800745?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 81 participants. The study started on 2018-11-09. Estimated completion is 2020-05-05.
What conditions does trial NCT03800745 study?
This clinical trial studies the following conditions: Postoperative Passage of Flatus, Postoperative Bowel Movement.
What interventions are being tested in trial NCT03800745?
The interventions under investigation include: Colace 100Mg Capsule (DRUG), Miralax (DRUG).
Who is sponsoring clinical trial NCT03800745?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03800745 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03800745's enrollment target sits among peer trials
81 940th of 2000 higher than 1,056 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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