Status:
TERMINATED
Loperamide vs. Placebo's Effect on Ileostomy Output: A Clinical Randomized Blinded Cross-over Study
Lead Sponsor:
Odense University Hospital
Conditions:
Rectal Cancer
Ulcerative Colitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Clinical experience show limited effect of the drug Loperamide used to decrease output in stoma patients. Therefore the investigators see the need for a randomized blinded clinical trial to determine ...
Detailed Description
The aim of this study is to quantify the effect of Loperamide on ileostomy output in patients operated for rectal cancer, ulcerative colitis and in patients with short bowl syndrome. These patients ar...
Eligibility Criteria
Inclusion
- Operation for rectal cancer or ulcerative colitis an ileostomy (loop or end ileostomy within the last 7 days) OR
- ileostomy patient with contact to the stoma clinic OR
- Short bowel syndrome with a permanent ileostomy
- signed consent form
Exclusion
- Complications associated with surgery
- Non-radical surgery
- Chemotherapy
- Poor compliance
- Other serious illness
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT02266849
Start Date
October 1 2014
End Date
August 1 2015
Last Update
October 11 2016
Active Locations (1)
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1
Odense University Hospital, Surgical Department A
Odense, Denmark, 5000