High Output Stoma Clinical Trial
— ILEHOSOfficial title:
Evaluation of Lanreotide Efficacity in High Output Stoma: a Multicentric Randomized Study
| Verified date | March 2018 |
| Source | University Hospital, Strasbourg, France |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Terminated |
| Enrollment | 19 |
| Est. completion date | January 26, 2018 |
| Est. primary completion date | December 31, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Legal at the time of signing the agreement - Subject affiliated to the french social protection - Ileostomy has achieved since 10 days minimum at day 0 (D0: start of study treatment) - Ileostomy output > 1.5 liters / 24h for at least 24 hours at day 0 - accept to use an effective method of contraception during the study: (during the 6 months following injection of lanreotide for the experimental group and for the control group: 4 days after the last dose of chlorhydrate of loperamide - People able to understand the objectives, modalities and risks related to the study and give written informed consent Exclusion Criteria: - people with guardianship or with judicial protection - simultaneous participation in another biomedical research protocol involving a drug or topic exclusion period - pregnancy or breastfeeding - administration of lanreotide or related peptide between surgery and D0 - hypersensitivities to lanreotide or related peptides and / or diosmectite and / or loperamide and / or one of their excipients - acute hemorrhagic colitis - bloody diarrhea and / or high fever - Clostridium Difficile Infection at the inclusion - uncontrolled diabetis defined by HbA1c> 7% at D0 |
| Country | Name | City | State |
|---|---|---|---|
| France | Hôpital Jean Minjoz - Service de Chirurgie Digestive | Besançon | |
| France | Hôpitaux Civils de Colmar - Service de Chirurgie Digestive | Colmar | |
| France | Hopital du Bocage - CHU Dijon- Service de Chirurgie Digestive | Dijon | |
| France | Hôpital Emile MULLER - Service de Chirurgie Digestive | Mulhouse | |
| France | CHU Robert Debré Service de chirurgie générale, digestive et endocrinienne | Reims | |
| France | Hôpital de Hautepierre-Service de Chirurgie Digestive | Strasbourg |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Strasbourg, France | Ipsen |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of ileostomy bags used per day | 72 hours | ||
| Secondary | Number of ileostomy bags used per day | from Day 0 to Day 6 | ||
| Secondary | Blood urea and creatinine rates | every 2 days until Day6 (Day 0, Day 2, Day 4, Day 6) | ||
| Secondary | Length of stay | duration of hospital stay, an expected average of 6 days | ||
| Secondary | Serious adverse events | Day 0, Day 1 Day 2, Day3, Day 4, Day 5, Day 6, 1 month |