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.