drugset / Trial / NCT02354768

Evaluation of Lanreotide Efficacity in High Output Stoma: a Multicentric Randomized Study

NCT02354768

RandomizedParallel-groupOpen-labelTreatment

Summary

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

Timeline

Start
2015-10-22
Primary completion
2017-12-31
Completion
2018-01-26

Drugs

EvaluationDrugModalityDoseRoute
Subject Lanreotide Other / unclassified 120 mg
Background Loperamide Small molecule 2 mg
Background montmorillonite Other / unclassified 3 g

Indications

No indication recorded.