Use of Post Operative Loperamide in Colorectal Patients After Diverting Ileostomies

Cedars-Sinai Medical Center

Status and phase: Terminated; Phase 3

Conditions: Dehydration, Diverting Ileostomy, Loperamide

Treatments: Drug: Loperamide

Study type: Interventional

Funder types: Other

Identifiers

NCT02263365

Loperamide Dehydration

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Able to freely give written informed consent to participate in the study and have signed the Informed Consent Form;
2. Males or females, age 18 and older at the time of study screening;
3. American Society of Anesthesiologists (ASA) Class I-III (Appendix III) undergoing elective surgery

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Control

No Intervention group

Therapeutic

Experimental group

Description:

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

Treatment:

Drug: Loperamide