Prospective Randomized Control Study on Effect of Post Operative Loperamide in Decreasing Readmission for Dehydration in Colorectal Patients After Diverting Ileostomies

Status: Terminated
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

Dehydration post creation of a diverting ileostomy is a common and debilitating problem faced by patients undergoing ileal-anal pouch anastomoses for both inflammatory bowel disease and familial adenomatous polyposis (FAP) syndrome. Those patients with low rectal cancers or other polyposis syndromes e.g. HNPCC hereditary non polyposis colorectal cancers, may potentially have a delay in the adjuvant therapy when faced with this complication. Studies performed in this groups of patients report a readmission rate of 17-21% for dehydration. Loperamide has been shown to significantly decrease the daily volume of weight of stool in these patients. The purpose of this study is to establish whether loperamide given at 4mg three times daily for 14 days from day of discharge empirically decreases 30 days readmission rate for dehydration. The investigators hypothesize that there will be a 15% decrease from 25% to 10% in the readmission rates, that severity of dehydration will be decreased.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• Able to freely give written informed consent to participate in the study and have signed the Informed Consent Form;

• Males or females, age 18 and older at the time of study screening;

• American Society of Anesthesiologists (ASA) Class I-III (Appendix III) undergoing elective surgery

Locations
United States
California
Cedars Sinai Medical Center
Los Angeles
Time Frame
Start Date: 2014-10-07
Completion Date: 2016-12-31
Participants
Target number of participants: 40
Treatments
No_intervention: Control
Experimental: Therapeutic
Patients randomized to this arm will be administered 4mg tid (three times daily) of loperamide from the day of discharge onwards. A total of duration of 14 days of medication will be administered
Related Therapeutic Areas
Sponsors
Leads: Cedars-Sinai Medical Center

This content was sourced from clinicaltrials.gov