Actively Recruiting
Prospective Study of the Methods and Outcomes of CHYME REinstillation After Small Bowel Surgery
Led by Nantes University Hospital · Updated on 2024-12-30
100
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research focuses on patients with high-output enterocutaneous fistulas (HOF) and double enterostomies, which are serious complications following abdominal surgery or trauma. These conditions cause excessive loss of digestive fluids and nutrients, leading to dehydration, intestinal failure, and significant challenges in patient care. The study aims to evaluate chyme reinfusion (CR) using a home-compatible device to improve management, reduce dependence on parenteral nutrition, and enhance quality of life. The study investigates the use of the Insides System device, a miniaturized portable pump that enables patients to perform chyme reinfusion independently outside hospital settings. This device allows the reinfusion of digestive fluids back into the intestine, potentially correcting nutritional imbalances and reducing hospital stays. The evaluation compares nutritional data and digestive losses before and after starting CR, with analysis of additional health outcomes during the CR period. Participants will undergo assessments of their nutritional status and digestive losses, with digestive contrast imaging performed to confirm anatomy. Researchers will monitor the effectiveness of the Insides System over one year, focusing on improvements in hydration and nutrition. The study includes safety monitoring and observation of patient ability to manage the device, with the goal of supporting outpatient care and improving patient independence.
CONDITIONS
Brief Title
Prospective Study of the Methods and Outcomes of CHYME REinstillation After Small Bowel Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- High-output stoma or enterocutaneous fistula with digestive output over 1500 mL per day or over 1000 mL per day affecting hydration and nutrition
- Double enterostomy or enterocutaneous fistula with anatomy allowing chyme reinfusion
- Confirmed patency of the downstream digestive segment by digestive contrast imaging
- Adults aged 18 years or older
You will not qualify if you...
- Stricture or fistula in the downstream digestive segment
- Patient refusal to use the device
- Fine motor or cognitive impairments preventing device handling by patient or caregiver
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 year
Participants use the Insides System device to perform chyme reinfusion independently, enabling outpatient management.
Visits as needed for device setup and monitoring
Duration - Up to 1 year
Participants are observed to assess nutritional data and digestive losses before and during chyme reinfusion using the device.
Periodic visits depending on participant status
Trial Site Locations
Total: 1 location
1
CHU de Nantes
Nantes, Nantes, France, 44000
Actively Recruiting
Research Team
E
EMILIE DUCHALAIS, MD PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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