Back to resultsUse of Post Operative Loperamide in Colorectal Patients After Diverting Ileostomies
Primary Purpose
Dehydration, Diverting Ileostomy, Loperamide
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Loperamide
Sponsored by
About this trial
This is an interventional prevention trial for Dehydration, Diverting Ileostomy, Loperamide
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Cedars Sinai Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Therapeutic
Arm Description
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
Outcomes
Primary Outcome Measures
Incidence of 30 Day Readmission (Severe Dehydration)
Secondary Outcome Measures
Moderate Dehydration Resulting in Outpatient Visits or ER Intervention That is =/<24hrs That Did Not Require Hospital Admission
Mild Dehydration - Subjective Report of Difficulty in Managing Fluid Balances and Stoma Care
Full Information
NCT ID
NCT02263365
First Posted
October 8, 2014
Last Updated
November 22, 2017
Sponsor
Cedars-Sinai Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02263365
Brief Title
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
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Terminated
Why Stopped
Unable to meet study requirements
Study Start Date
October 7, 2014 (Actual)
Primary Completion Date
December 31, 2016 (Actual)
Study Completion Date
December 31, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cedars-Sinai Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dehydration, Diverting Ileostomy, Loperamide
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Title
Therapeutic
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Loperamide
Intervention Description
Loperamide 12mg per day (4mg t.i.d) for 2 weeks post discharge
Primary Outcome Measure Information:
Title
Incidence of 30 Day Readmission (Severe Dehydration)
Time Frame
30 day
Secondary Outcome Measure Information:
Title
Moderate Dehydration Resulting in Outpatient Visits or ER Intervention That is =/<24hrs That Did Not Require Hospital Admission
Time Frame
30 day
Title
Mild Dehydration - Subjective Report of Difficulty in Managing Fluid Balances and Stoma Care
Time Frame
30 days
Other Pre-specified Outcome Measures:
Title
Length of Index Admission
Time Frame
30 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip R Fleshner, MD
Organizational Affiliation
Cedars-Sinai Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Use of Post Operative Loperamide in Colorectal Patients After Diverting Ileostomies
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