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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms

  • Dehydration
  • Dehydration, Diverting Ileostomy, Loperamide

NCT number NCT02263365
Study type Interventional
Source Cedars-Sinai Medical Center
Contact
Status Terminated
Phase Phase 3
Start date October 7, 2014
Completion date December 31, 2016