Use of Post Operative Loperamide in Colorectal Patients After Diverting Ileostomies

Dehydration, Diverting Ileostomy, Loperamide Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02263365
• Other study ID #: Loperamide Dehydration
• Status: Terminated
• Phase: Phase 3
• First received: October 8, 2014
• Last updated: November 22, 2017
• Start date: October 7, 2014
• Est. completion date: December 31, 2016

Study information

• Verified date: November 2017
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: December 31, 2016
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dehydration
• Dehydration, Diverting Ileostomy, Loperamide

Intervention

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

Locations

Country	Name	City	State
United States	Cedars Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Length of Index Admission		30 day
Primary	Incidence of 30 Day Readmission (Severe Dehydration)		30 day
Secondary	Moderate Dehydration Resulting in Outpatient Visits or ER Intervention That is =/<24hrs That Did Not Require Hospital Admission		30 day
Secondary	Mild Dehydration - Subjective Report of Difficulty in Managing Fluid Balances and Stoma Care		30 days