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)

NCT02792543 | Unknown DMC

• 1 other identifier: 69HCL16_0098
• Study Type: interventional
• Target: 268
• Locations: 1 country
• Sites: 1

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.

Conditions

Intestinal Failure With a Temporary High-output Double Enterostomy

Keywords

nutrition; double enterostomy; chyme reinfusion; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• 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))

Study Arms (2)

parenteral nutrition

ACTIVE COMPARATOR

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

Drug: parenteral nutrition

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.

Device: Entéromate™

Interventions

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.

Also known as: chyme reinfusion

chyme reinfusion

parenteral nutrition DRUG

Parenteral nutrition (the gold standard treatment) consists of electrolyte supplementation, hydration, and nutrition through a central venous catheter.

parenteral nutrition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hospices Civils de Lyon - Hôpital de la Croix Rousse

Lyon, 69004, France

Location

MeSH Terms

Interventions

Parenteral Nutrition

Intervention Hierarchy (Ancestors)

Feeding Methods; Therapeutics; Nutritional Support; Nutrition Therapy

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2016
• First Posted: June 7, 2016
• Study Start: January 1, 2017
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: June 8, 2016

Record last verified: 2016-06

Locations

FR (1)