A Phase 3 interventional study of Effects of lanreotide with current anti-diarrheal treatments (diosmectite and loperamide) and Effects of current anti-diarrheal treatments (diosmectite and loperamide) alone in High Output Stoma, sponsored by University Hospital, Strasbourg, France. Terminated at 6 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-07.
Sponsored by University Hospital, Strasbourg, France · Phase 3, Interventional, and Treatment
Dehydration is a major problem of high output stoma with a 17% rate of readmission at 30 days. Dehydratations are resulting of significant electrolyte loss: sodium, potassium and renal failure. Nowadays, there are no recommendations nor national nor international for high output ileostomy treatment. Apart from the anti-diarrhea treatments used in current practice, somatostatin analogs have proven efficacy in the literature. Theses analogs permit to decrease significantly gastrointestinal secretions. Several teams use these analogs in order to decrease the flow of highly productive ileostomy.
The aim of the study is to evaluate the efficacy first line treatment with lanreotide associated with current anti-diarrheal treatment for patients with high output ileostomy (or greater throughput 1.5l / 24h) with or without associated dehydration
University Hospital, Strasbourg, France is the lead sponsor of 966 studies on the registry; 342 are open to participants now.
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Exclusion Criteria:
* Lanreotide: 1 single injection at day 0 (lanreotide 120 mg) * Diosmectite (3 g) 6 / day for 72 hours (fromD0 to D3) * Chlorhydrate of Loperamide (2 mg capsule or tablet) 6 / day for 72 hours (D0 to D3) * hydration
Drug: Effects of lanreotide with current anti-diarrheal treatments (diosmectite and loperamide)
* Diosmectite (3 g) 6 / day for 72 hours (fromD0 to D3) * Chlorhydrate of Loperamide (2 mg capsule or tablet) 6 / day for 72 hours (D0 to D3) * Hydration
Drug: Effects of current anti-diarrheal treatments (diosmectite and loperamide) alone
Number of ileostomy bags used per day
Time frame: 72 hours
Number of ileostomy bags used per day
Time frame: from Day 0 to Day 6
Blood urea and creatinine rates
Time frame: every 2 days until Day6 (Day 0, Day 2, Day 4, Day 6)
Length of stay
Time frame: duration of hospital stay, an expected average of 6 days
Serious adverse events
Time frame: Day 0, Day 1 Day 2, Day3, Day 4, Day 5, Day 6, 1 month
Plan to share: No
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This study is terminated, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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University Hospital, Strasbourg, France