Use of Post Operative Loperamide in Colorectal Patients After Diverting Ileostomies

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

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.

Study Overview

• Status: Terminated
• Conditions: Dehydration, Diverting Ileostomy, Loperamide
• Intervention / Treatment: Drug: Loperamide

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars Sinai Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: 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	Drug: Loperamide; Loperamide 12mg per day (4mg t.i.d) for 2 weeks post discharge

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	Time Frame
Length of Index Admission	30 day

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center
• Investigators: Principal Investigator: Philip R Fleshner, MD, Cedars-Sinai Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2014
• Primary Completion (Actual): December 31, 2016
• Study Completion (Actual): December 31, 2016

Study Registration Dates

• First Submitted: October 8, 2014
• First Submitted That Met QC Criteria: October 10, 2014
• First Posted (Estimate): October 13, 2014

Study Record Updates

• Last Update Posted (Actual): December 20, 2017
• Last Update Submitted That Met QC Criteria: November 22, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Water-Electrolyte Imbalance; Dehydration; Gastrointestinal Agents; Loperamide; Antidiarrheals
• Other Study ID Numbers: Loperamide Dehydration