Study of Chyme Reinfusion Methods and Outcomes Using the Insides System Device After Small Bowel Surgery in Patients with High-Output Enterostomy

What this Trial Is About

High-output enterocutaneous fistulas (HOF) and double enterostomies are serious complications after abdominal surgery or trauma that cause significant fluid and nutrient loss, often leading to severe dehydration and intestinal failure. Managing these conditions requires complex care and often depends on parenteral nutrition (PN), which is linked to longer hospital stays and increased health risks. Researchers are evaluating a new portable device called the Insides System that enables patients to perform chyme reinfusion (CR) independently at home, aiming to reduce reliance on PN and improve patient outcomes. The Insides System device is a miniaturized pump designed to allow patients to carry out CR outside the hospital setting. CR involves transferring digestive fluids back into the bypassed intestine to restore lost nutrients and fluids. This study compares nutritional status and digestive losses before and after starting CR with the device. The focus is on patients with HOF or double enterostomy who have an anatomical setup suitable for CR and confirmed downstream digestive tract patency. Participants will be monitored to assess the effectiveness of the Insides System over a one-year period. Researchers will collect nutritional data, measure digestive losses, and analyze other health outcomes using descriptive and analytical methods. The study aims to improve hydration, nutritional status, and quality of life by enabling outpatient management of these complex digestive conditions.

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