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)

Not Applicable

Conditions: Intestinal Failure With a Temporary High-output Double Enterostomy

Brief Summary: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
parenteral nutrition	parenteral nutrition	Parenteral nutrition consists of electrolyte supplementation, hydration, and nutrition through a central venous catheter.
chyme reinfusion	Entéromate™	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.

Primary Outcome Measures

Name	Time	Method
The frequency of complications occurring in patients with a temporary high-output double enterostomy.	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))	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.

Secondary Outcome Measures

Name	Time	Method

Locations (1): Hospices Civils de Lyon - Hôpital de la Croix Rousse
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Lyon, France

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