NCT06751628: CHYMERE

Prospective Study of the Methods and Outcomes of CHYME REinstillation After Small Bowel Surgery

Recruiting now Last updated 30 December 2024

What this trial tests

trial testing Insides system in Enterostomy in 100 participants. Currently enrolling.

Timeline

14 July 2024

Primary endpoint
14 July 2029

14 July 2030

Quick facts

Lead sponsor	Nantes University Hospital
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	100
Start date	14 July 2024
Primary completion	14 July 2029
Estimated completion	14 July 2030
Sites	1 location across France

Drugs / interventions tested

• Insides system

Conditions studied

• Enterostomy — all drugs for Enterostomy →

Sponsor

Nantes University Hospital

Who can join

18 and older, any sex, with Enterostomy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

High-output enterocutaneous fistulas (HOF) and double enterostomies are severe complications of abdominal surgery or trauma. Double enterostomies are typically created after small bowel resection in fragile patients who cannot tolerate intestinal reconnection. Reconnection is generally performed 3-6 months later, once patients have regained sufficient healing capacity. In contrast, HOFs occur when intestinal anastomosis healing fails, causing digestive secretions to exit through the abdominal wall. HOFs lead to excessive loss of fluids and nutrients, defined as digestive output exceeding 1500 mL per day for two consecutive days. This often results in severe dehydration and intestinal failure.

Managing HOFs is a complex, resource-intensive process requiring multidisciplinary care to compensate for losses and ensure patient survival. These conditions cause significant patient burden, increase healthcare costs, and often necessitate parenteral nutrition (PN). PN is associated with longer hospital stays, higher risks of central line infections, venous thrombosis, and liver complications (de Vries et al., 2021).

Innovative approaches are needed to restore lost digestive fluids and nutrients in HOF patients. Such solutions could mitigate intestinal failure, reduce PN reliance, prevent dehydration and kidney failure, shorten hospital stays, and improve quality of life by enabling home care. Chyme reinfusion (CR) is an established technique for transferring digestive fluids back into the bypassed intestine (Figure 1A). Historically, this procedure relied on bulky peristaltic pumps available only in specialized centers, with fewer than ten centers in France offering the service. CR has shown significant benefits, with over 85% of patients discontinuing PN and improving nutritional status (Bhat et al., 2020).

A novel, portable pump system developed by Insides System allows patients to independently perform CR and manage their care in outpatient settings. A case series of 10 patients demonstrated that the Insides System enabled PN discontinuation, corrected liver and electrolyte imbalances, and allowed most patients to return home with CR (Sharma et al., 2017).

The CHYMERE study aims to evaluate the effectiveness of chyme reinfusion using a home-compatible device for patients with HOF.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.