Use of Post Operative Loperamide in Colorectal Patients After Diverting Ileostomies
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|ClinicalTrials.gov Identifier: NCT02263365|
Recruitment Status : Terminated (Unable to meet study requirements)
First Posted : October 13, 2014
Results First Posted : December 20, 2017
Last Update Posted : December 20, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Dehydration, Diverting Ileostomy, Loperamide||Drug: Loperamide||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Randomized Control Study on Effect of Post Operative Loperamide in Decreasing Readmission for Dehydration in Colorectal Patients After Diverting Ileostomies|
|Actual Study Start Date :||October 7, 2014|
|Actual Primary Completion Date :||December 31, 2016|
|Actual Study Completion Date :||December 31, 2016|
|No Intervention: Control|
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
Loperamide 12mg per day (4mg t.i.d) for 2 weeks post discharge
- Incidence of 30 Day Readmission (Severe Dehydration) [ Time Frame: 30 day ]
- Moderate Dehydration Resulting in Outpatient Visits or ER Intervention That is =/<24hrs That Did Not Require Hospital Admission [ Time Frame: 30 day ]
- Mild Dehydration - Subjective Report of Difficulty in Managing Fluid Balances and Stoma Care [ Time Frame: 30 days ]
- Length of Index Admission [ Time Frame: 30 day ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02263365
|United States, California|
|Cedars Sinai Medical Center|
|Los Angeles, California, United States, 90048|
|Principal Investigator:||Philip R Fleshner, MD||Cedars-Sinai Medical Center|