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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 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. The trial reports 1 study location across 1 state.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03800745
The ClinicalTrials.gov registry entry for NCT03800745 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 81 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Cleveland Clinic, which has 688 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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