Evaluating chyme reinfusion methods after small bowel surgery
Prospective Study of the Methods and Outcomes of CHYME REinstillation After Small Bowel Surgery
This study is testing if a method called chyme reinfusion can help patients with serious digestive issues after bowel surgery by improving their nutrition and reducing fluid loss.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nantes University Hospital Academic / other |
| Locations | 1 site (Nantes, Nantes) |
| Trial ID | NCT06751628 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with high-output enterocutaneous fistulas and double enterostomies, which are serious complications following abdominal surgery. It aims to assess the nutritional outcomes and digestive losses before and after the implementation of chyme reinfusion (CR) therapy. By comparing data from the periods before and during CR, the study seeks to understand the effectiveness of this intervention in managing fluid and nutrient loss. The methodology includes both descriptive and analytical approaches to evaluate the impact of CR on patient health.
Who should consider this trial
Good fit: Ideal candidates include patients with high-output stomas or enterocutaneous fistulas producing over 1500 mL of output per day, or over 1000 mL with adverse effects on hydration and nutrition.
Not a fit: Patients with strictures or fistulas in the downstream digestive segment, or those unable to use the device due to cognitive or motor impairments, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve the management of patients with high-output enterostomies, potentially reducing the need for parenteral nutrition and enhancing their quality of life.
How similar studies have performed: While the approach of chyme reinfusion is innovative, similar studies have not been widely reported, indicating this may be a novel intervention.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: High-output stoma or enterocutaneous fistula (\>1500 mL per day or \>1000 mL per day with impact on hydration and nutritional status) Double enterostomy or enterocutaneous fistula with an anatomical configuration allowing chyme reinfusion (CR) Confirmed patency of the downstream digestive segment through digestive contrast imaging Exclusion Criteria: Stricture or fistula in the downstream digestive segment Patient refusal to use the device Fine motor or cognitive impairments preventing the patient or a caregiver from handling the device
Where this trial is running
Nantes, Nantes
- CHU de Nantes — Nantes, Nantes, France (Recruiting)
Study contacts
- Study coordinator: EMILIE DUCHALAIS, MD PhD
- Email: EMILIE.DUCHALAIS@CHU-NANTES.FR
- Phone: 0253484322
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.