Use of Post Operative Loperamide in Colorectal Patients After Diverting Ileostomies

NCT ID: NCT02263365

Last Updated: 2017-12-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-07
• Study Completion Date: 2016-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Therapeutic

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

Group Type: EXPERIMENTAL

Loperamide

Intervention Type: DRUG

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

Interventions

Loperamide

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cedars-Sinai Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Phillip Fleshner MD

Director of Colorectal Residency

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Philip R Fleshner, MD

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Locations

Cedars Sinai Medical Center

Los Angeles, California, United States

Countries

United States

Other Identifiers

Loperamide Dehydration

Identifier Type: -

Identifier Source: org_study_id