Clinical trial NCT02263365: Use of Post Operative Loperamide in Colorectal Patients After Diverting Ileostomies
Official title: Prospective Randomized Control Study on Effect of Post Operative Loperamide in Decreasing Readmission for Dehydration in Colorectal Patients After Diverting Ileostomies
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Dehydration, Diverting Ileostomy, Loperamide
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2014-10-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Incidence of 30 Day Readmission (Severe Dehydration)
timeFrame: 30 day
Secondary outcomes:
measure: Moderate Dehydration Resulting in Outpatient Visits or ER Intervention That is =/<24hrs That Did Not Require Hospital Admission
timeFrame: 30 day
measure: Mild Dehydration - Subjective Report of Difficulty in Managing Fluid Balances and Stoma Care
timeFrame: 30 days
Other outcomes:
measure: Length of Index Admission
timeFrame: 30 day
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Philip R Fleshner, MD
role: PRINCIPAL_INVESTIGATOR
References: