Reduction of Postoperative Gastrointestinal Dysmotility Following Total Laparoscopic Hysterectomy.
Completed · Phase 4
Conditions studied: Postoperative Passage of Flatus, Postoperative Bowel Movement
In brief
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.
Key facts
- Study ID
- NCT03800745
- Run by
- The Cleveland Clinic
- People needed
- 81
- Starts
- 2018-11-09
- Expected to finish
- 2020-05-05
- Last updated by the study team
- 2020-06-02
Who can join
Age: 18 and older, up to 85. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- aged 18-85 undergoing minimally invasive gynecologic surgery in the form of total laparoscopic hysterectomy.
You may not qualify if…
- an underlying gynecologic malignancy, pre-existing gastrointestinal disorders, history of bowel resection, insulin-dependent diabetes or gastroparesis, known gastric dysmotility, chronic use of pain medications, or anticipated bowel surgery
Where it is running
- Cleveland Clinic Florida — Weston, Florida, United States
Full record on ClinicalTrials.gov
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