Use of Post Operative Loperamide in Colorectal Patients After Diverting Ileostomies

NCT02263365 | Terminated Phase 3 Results

• 1 other identifier: Loperamide Dehydration
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Incidence of 30 Day Readmission (Severe Dehydration)

  30 day

Secondary Outcomes (2)

• 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 Outcomes (1)

• Length of Index Admission

  30 day

Study Arms (2)

Control

NO INTERVENTION

Therapeutic

EXPERIMENTAL

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

Interventions

Loperamide DRUG

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

Therapeutic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Dehydration

Interventions

Loperamide

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

Study only accrued 40 patients. Due to issues with enrollment and study procedures compliance it was decided to terminate the study. Data analysis will not be done for this study. This study has been closed with the internal review board.

Results Point of Contact

• Title: Phillip Fleshner, MD
• Organization: Cedars Sinai Medical Center

pfleshner@aol.com

310-289-9224

Study Officials

• Philip R Fleshner, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Colorectal Residency

Study Record Dates

• First Submitted: October 8, 2014
• First Posted: October 13, 2014
• Study Start: October 7, 2014
• Primary Completion: December 31, 2016
• Study Completion: December 31, 2016
• Last Updated: December 20, 2017
• Results First Posted: December 20, 2017

Record last verified: 2017-11

Locations

US (1)