NCT02354768

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: University Hospital, Strasbourg, France · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• High Output Stoma

Interventions

Type	Name	Description
DRUG	Effects of lanreotide with current anti-diarrheal treatments (diosmectite and loperamide)
DRUG	Effects of current anti-diarrheal treatments (diosmectite and loperamide) alone

Timeline

• Start date: 2015-10-22
• Primary completion: 2017-12-31
• Completion: 2018-01-26
• First posted: 2015-02-03
• Last updated: 2018-03-07

Locations

6 sites across 1 country: France