Impact of Chyme Reinfusion Compared to Parenteral Nutrition on the Incidence of Complications in Patients With a Temporary High-output Double Enterostomy: a Multicentre Randomized Controlled Trial - FRY: efFiciency of Reinfusion of chYme - (FRY)

Study Overview
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Brief Summary
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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.

Official Title
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Impact of Chyme Reinfusion Compared to Parenteral Nutrition on the Incidence of Complications in Patients With a Temporary High-output Double Enterostomy: a Multicentre Randomized Controlled Trial - FRY: efFiciency of Reinfusion of chYme - (FRY)

Conditions
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Intestinal Failure With a Temporary High-output Double Enterostomy

Intervention / Treatment
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* Device: Entéromate™
* Drug: parenteral nutrition


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged over 18 years Temporary high-output double enterostomy (≥1500ml/24 hours) Total small bowel length ≥ 120 cm Downstream small bowel consisting of at least 25 cm of healthy bowel, accessible by a stoma, and suitable for chyme reinfusion Oral feeding resumed for at least 5 days Parenteral nutrition or hydration required until the surgical reestablishment of digestive continuity Affiliation to an health insurance (general Social Security scheme or an equivalent scheme) No current or planned participation in another biomedical research Signature of an informed consent form Exclusion Criteria: Expected duration of parenteral nutrition or chyme reinfusion less than 2 weeks Refusal by the patient to have a mixed texture diet, Chemotherapy or radiotherapy before the surgical reestablishment of digestive continuity, Not drained intra-abdominal collection, Fever, uncontrolled infection, or infection treated for less than 72 hours, Shock of any cause, Creatinine clearance ≤ 60 ml/min Patients under guardianship.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: parenteral nutrition<br>Parenteral nutrition consists of electrolyte supplementation, hydration, and nutrition through a central venous catheter. | Drug: parenteral nutrition<br>* Parenteral nutrition (the gold standard treatment) consists of electrolyte supplementation, hydration, and nutrition through a central venous catheter.<br>|
| Experimental: chyme reinfusion<br>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. | Device: Entéromate™<br>* 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.<br>* Other names: chyme reinfusion;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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)) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nutrition, double enterostomy, chyme reinfusion, randomized controlled trial