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) (FRY)

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.

Study Overview

• Status: Unknown
• Conditions: Intestinal Failure With a Temporary High-output Double Enterostomy
• Intervention / Treatment: Drug: parenteral nutrition; Device: Entéromate™

• Study Type: Interventional
• Enrollment (Anticipated): 268
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69004
    • Hospices Civils de Lyon - Hôpital de la Croix Rousse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: parenteral nutrition; Parenteral nutrition consists of electrolyte supplementation, hydration, and nutrition through a central venous catheter.	Drug: parenteral nutrition; Parenteral nutrition (the gold standard treatment) consists of electrolyte supplementation, hydration, and nutrition through a central venous catheter.
EXPERIMENTAL: chyme reinfusion; 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™; 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.; Other Names: chyme reinfusion

What is the study measuring?

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))

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (ANTICIPATED): September 1, 2020
• Study Completion (ANTICIPATED): September 1, 2020

Study Registration Dates

• First Submitted: June 2, 2016
• First Submitted That Met QC Criteria: June 6, 2016
• First Posted (ESTIMATE): June 7, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): June 8, 2016
• Last Update Submitted That Met QC Criteria: June 7, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: randomized controlled trial; nutrition; double enterostomy; chyme reinfusion
• Other Study ID Numbers: 69HCL16_0098