Status:
TERMINATED
Use of Post Operative Loperamide in Colorectal Patients After Diverting Ileostomies
Lead Sponsor:
Cedars-Sinai Medical Center
Conditions:
Dehydration, Diverting Ileostomy, Loperamide
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 adeno...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 7 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2016
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT02263365
Start Date
October 7 2014
End Date
December 31 2016
Last Update
December 20 2017
Active Locations (1)
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1
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048