Prunes for Gastrointestinal Function After Gynecologic Surgery
Stopped early · Phase 4
Conditions studied: Constipation
In brief
This is a prospective, randomized control trial that randomizes patients post-operatively into standard care versus standard care plus prunes. Patients in the control arm will take 100 mg docusate twice per day for 3 days (standard care). Participants in the treatment arm will consume 4 oz prunes daily and take 100 mg docusate twice per day for 3 days. The primary objective is to determine the time to first bowel movement after surgery.
Key facts
- Study ID
- NCT03523715
- Run by
- University of Southern California
- People needed
- 77
- Starts
- 2017-11-30
- Expected to finish
- 2020-07-31
- Last updated by the study team
- 2021-04-08
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Female patients seen in the Gynecology or Urogynecology clinics at LAC+USC Medical Center who are planned for surgery requiring at least 24 hour stay
- Age 18 or greater
- Able to give informed consent
- No contraindications to docusate or prune consumption
You may not qualify if…
- Unable to give informed consent
- Unwilling to follow protocol
- Active malignancy
- Emergency surgery
- Diabetes mellitus
- Inflammatory bowel disease, gastroparesis, or other bowel disorder
- History of bowel resection or presence of colostomy
- Dependence on regular laxative use prior to surgery
- Baseline frequency of bowel movements less than weekly
- Intraoperative enterotomy or any bowel surgery performed at the time of surgery
- Patient unable to initiate oral intake on post op day 1 for any reason
- Allergy to docusate or prunes
Where it is running
- Los Angeles Count + USC Medical Center — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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