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| Name | Class |
|---|---|
| Ipsen | INDUSTRY |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lanreotide and anti-diarrheal treatments | Experimental |
|
|
| Current anti-diarrheal treatments alone | Active Comparator |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Effects of lanreotide with current anti-diarrheal treatments (diosmectite and loperamide) | Drug |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| Number of ileostomy bags used per day | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of ileostomy bags used per day | from Day 0 to Day 6 | |
| Blood urea and creatinine rates | every 2 days until Day6 (Day 0, Day 2, Day 4, Day 6) | |
| Length of stay |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benoit ROMAIN, MD | Hôpitaux Universitaires de Strasbourg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Jean Minjoz - Service de Chirurgie Digestive | Besançon | 25030 | France | |||
| Hôpitaux Civils de Colmar - Service de Chirurgie Digestive |
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| Effects of current anti-diarrheal treatments (diosmectite and loperamide) alone |
| Drug |
|
| duration of hospital stay, an expected average of 6 days |
| Serious adverse events | Day 0, Day 1 Day 2, Day3, Day 4, Day 5, Day 6, 1 month |
| Colmar |
| 68024 |
| France |
| Hopital du Bocage - CHU Dijon- Service de Chirurgie Digestive | Dijon | France |
| Hôpital Emile MULLER - Service de Chirurgie Digestive | Mulhouse | 68070 | France |
| CHU Robert Debré Service de chirurgie générale, digestive et endocrinienne | Reims | 51100 | France |
| Hôpital de Hautepierre-Service de Chirurgie Digestive | Strasbourg | 67098 | France |
| ID | Term |
|---|---|
| C033214 | Smectite |
| D008139 | Loperamide |
| D012847 | Single Person |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D017533 | Marital Status |
| D005191 | Family Characteristics |
| D003710 | Demography |
| D011154 | Population Characteristics |
| D012959 | Socioeconomic Factors |
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