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)

Civil Hospices of Lyon

Status: Unknown

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

Treatments: Device: Entéromate™; Drug: parenteral nutrition

Study type: Interventional

Funder types: Other

Identifiers

NCT02792543

69HCL16_0098

Details and patient eligibility

About

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.

Enrollment: 268 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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268 participants in 2 patient groups

parenteral nutrition

Active Comparator group

Description:

Parenteral nutrition consists of electrolyte supplementation, hydration, and nutrition through a central venous catheter.

Treatment:

Drug: parenteral nutrition

chyme reinfusion

Experimental group

Description:

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.

Treatment:

Device: Entéromate™