NCT02263365

Use of Post Operative Loperamide in Colorectal Patients After Diverting Ileostomies

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Cedars-Sinai Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dehydration, Diverting Ileostomy, Loperamide

Interventions

Type	Name	Description
DRUG	Loperamide	Loperamide 12mg per day (4mg t.i.d) for 2 weeks post discharge

Timeline

• Start date: 2014-10-07
• Primary completion: 2016-12-31
• Completion: 2016-12-31
• First posted: 2014-10-13
• Last updated: 2017-12-20
• Results posted: 2017-12-20

Locations

1 site across 1 country: United States