Clinical trial NCT02792543: 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)
Official title: 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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intestinal Failure With a Temporary High-output Double Enterostomy
Keywords: nutrition
double enterostomy
chyme reinfusion
randomized controlled trial
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-06-07
Enrollment: 268
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The frequency of complications occurring in patients with a temporary high-output double enterostomy.
timeFrame: 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))
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon - Hôpital de la Croix Rousse
Study officials:
References: