Use of Post Operative Loperamide in Colorectal Patients After Diverting Ileostomies

Study Overview
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Brief Summary
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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.

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

Conditions
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Dehydration, Diverting Ileostomy, Loperamide

Intervention / Treatment
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* Drug: Loperamide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Mentally incompetent or unable or unwilling to provide informed consent or comply with study procedures American Society of Anesthesiologists (ASA) Class IV or V; emergency surgeries Children <18 Pregnant patients Patients who have intra-abdominal sepsis or partial or intermittent bowel obstruction or enteritis Patients who are on long term steroids, opioids or antidiarrheals pre operatively Patients who are administered pro kinetics eg. Metoclopramide Patients with recurrent disease in their small bowel - Crohn's disease, or previous irradiated pelvis resulting in irradiation bowel disease End ileostomies

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br> | |
| Experimental: Therapeutic<br>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 | Drug: Loperamide<br>* Loperamide 12mg per day (4mg t.i.d) for 2 weeks post discharge<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of 30 Day Readmission (Severe Dehydration) |  | 30 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Moderate Dehydration Resulting in Outpatient Visits or ER Intervention That is =/<24hrs That Did Not Require Hospital Admission |  | 30 day | 
| Mild Dehydration - Subjective Report of Difficulty in Managing Fluid Balances and Stoma Care |  | 30 days |