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In the case of intestinal failure with a high-output double enterostomy, the parenteral nutrition (PN) is the gold standard treatment until the surgical reestablishment of digestive continuity. PN has its own morbidity, and in the absence of expertise, the risks of infectious, mechanical, and metabolic complications are increased. Chyme reinfusion (CR) is an enteral nutritional technique which reestablishes the functional continuity of the anatomically present small bowel through an extracorporeal circulation of the chyme. In patients with intestinal failure with a temporary high-output double enterostomy, we hypothesize that CR, compared to PN will reduce post-operative complications after surgical reestablishment of digestive continuity, maintain the intestinal function including absorption, and reduce the complications during the transitional period pending the surgical reestablishment of digestive continuity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| parenteral nutrition | Active Comparator | Parenteral nutrition consists of electrolyte supplementation, hydration, and nutrition through a central venous catheter. |
|
| chyme reinfusion | Experimental | Chyme reinfusion consists of continuously reinfusing the chyme collected from the proximal small bowel segment via the enterostomy, and into the diverted distal small bowel segment. It implies the use of the Entéromate™ pump. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Entéromate™ | Device | Chyme reinfusion (the experimental treatment) consists of continuously reinfusing the chyme collected from the proximal small bowel segment via the enterostomy, and into the diverted distal small bowel segment. It implies the use of the Entéromate™ pump. |
| Measure | Description | Time Frame |
|---|---|---|
| The frequency of complications occurring in patients with a temporary high-output double enterostomy. | The reestablishment of digestive continuity is possible between Month 3 and Month 8 (it is patient-dependent) The complications, and their severity, will be classed using the Dindo-Clavien classification. | From the day which the patient no longer requires surgical care after the surgical placement of a temporary double enterostomy (Day 0) and up to 30 days after the reestablishment of digestive continuity (Month 4 (minus) - Month 9 (plus)) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cécile CHAMBRIER, MD | Contact | +33 4 26 73 26 59 | cecile.chambrier@chu-lyon.fr | |
| Amélie ZELMAR | Contact | +33 4 72 11 51 15 | amelie.zelmar@chu-lyon.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospices Civils de Lyon - Hôpital de la Croix Rousse | Lyon | 69004 | France |
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|
| parenteral nutrition | Drug | Parenteral nutrition (the gold standard treatment) consists of electrolyte supplementation, hydration, and nutrition through a central venous catheter. |
|
| ID | Term |
|---|---|
| D010288 | Parenteral Nutrition |
| ID | Term |
|---|---|
| D005248 | Feeding Methods |
| D013812 | Therapeutics |
| D018529 | Nutritional Support |
| D044623 | Nutrition Therapy |
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