Comparing quality of life with or without seton placement for anal fistulas in Crohn's disease
Randomized Comparison of Quality of Life With or Without Automatic Seton Placement in Perianal Crohn's Fistula
This study tests whether placing a seton for anal fistulas helps people with Crohn's disease feel better compared to those who don't get the seton.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 108 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | Fondation Hôpital Saint-Joseph Academic / other |
| Drugs / interventions | infliximab, adalimumab |
| Locations | 1 site (Paris) |
| Trial ID | NCT05330416 on ClinicalTrials.gov |
What this trial studies
This study evaluates the impact of automatic seton placement on the quality of life in patients with anal fistulas due to Crohn's disease. It involves a comparison between patients receiving seton treatment and those who do not, focusing on the management of fistulas through a structured surgical approach. The study aims to determine whether the use of setons can improve outcomes by minimizing complications and enhancing patient well-being. Participants will be monitored for their quality of life and the effectiveness of the treatment strategy.
Who should consider this trial
Good fit: Ideal candidates are patients over 16 years old with an anal fistula requiring surgical management related to Crohn's disease.
Not a fit: Patients with a stoma or those who have already failed treatment with anti-TNF agents may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for anal fistulas in Crohn's disease, enhancing patients' quality of life.
How similar studies have performed: While seton placement is commonly used in clinical practice, the specific comparison of quality of life outcomes in this context is less explored, making this approach somewhat novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with an anal fistula requiring surgical management in the context of Crohn's disease, with or without anti-TNF treatment (infliximab or adalimumab) * Patient over 16 years of age (for minors, the consent of one of the parents will be requested) * Patient with health insurance coverage * French-speaking patient * Signed written informed consent Exclusion Criteria: * Patient already included in a type 1 interventional research protocol (RIPH1) * Patient under guardianship or curatorship * Patient incarcerated * Patient under legal protection * Patient refusing randomization or follow-up * Patient refusing the medical protocol for anti-TNF treatment (infliximab or adalimumab) * Patient already experiencing treatment failure on optimized infliximab treatment; by contrast, those experiencing treatment failure on adalimumab alone may be included * Patient allergic or intolerant to the two anti-TNF agents (infliximab and adalimumab) * Patient with a stoma * Patient with an ano-recto-vaginal fistula * Patient with anal or rectal stenosis * Patient with ileo-anal anastomosis * Patient without preoperative MRI
Where this trial is running
Paris
- Groupe Hospitalier Paris Saint-Joseph — Paris, France (Recruiting)
Study contacts
- Principal investigator: Nadia Fathallah, MD — Fondation Hôpital Saint-Joseph
- Study coordinator: Nadia Fathallah, MD
- Email: nfathallah@ghpsj.fr
- Phone: 1 44 12 71 83
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.