Safety of Mesentery-embedding Surgery in Patients With Ileocolic Crohn's Disease on Biotherapy
Not applicable · Testing ileocolic resection with extended mesenteric resection · 2 sites · Centre Hospitalier Universitaire de Nīmes
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing ileocolic resection with extended mesenteric resection (a procedure). Condition(s) listed: Crohn Disease.
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- The patient must have given their free and informed consent and signed the consent form
- The patient must be a member or beneficiary of a health insurance plan
- Patient with histologically proven Crohn's disease
Plus 3 more requirement(s). There are also 5 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 30 participants are expected to take part.
- Start date: 2025-09-15.
- Main results expected around 2027-10 (estimate from the record).
- 2 study sites listed (2 marked recruiting) in France.
Main thing being measured
- Post-surgical complication rate (30 days after surgery)
In the researchers’ words
60% of patients with Crohn's disease will undergo surgery during their lifetime and without recurrence prevention treatment, 80% of patients will have an endoscopic recurrence within 1 year of surgery. This procedure is performed as close as possible to the gastrointestinal tract, but remaining mesenteric disease is a risk factor for recurrence.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Crohn Disease |
| Lead sponsor | Centre Hospitalier Universitaire de Nīmes |
| Enrollment | 30 (estimated) |
| Start date | 2025-09-15 |
| Primary completion (est.) | 2027-10 |
| First posted | 2025-03-04 |
| Last updated | 2026-03-16 |
| Official title | Etude Prospective Exploratoire Pilote de sécurité, d'Une Chirurgie Emportant le mésentère Chez Les Patients Porteurs d'Une Maladie de Crohn Avec Atteinte iléo-colique Sous biothérapie |
| ClinicalTrials.gov ID | NCT06856044 |
Interventions
- ileocolic resection with extended mesenteric resection (Procedure)
The resection limits will be in healthy mesenteric areas. The restoration of continuity in one stage should be preferred. The choice of laparoscopy versus laparotomy is at the surgeon's discretion.
Full eligibility criteria (from the record)
Inclusion Criteria: * The patient must have given their free and informed consent and signed the consent form * The patient must be a member or beneficiary of a health insurance plan * Patient with histologically proven Crohn's disease * Patient who has undergone ileocolic resection and whose disease site is accessible to endoscopic follow-up (first or repeat operation) * Patient on anti-TNF α: infliximab or adalimumab (ECCO 2014 recommendation), vedolizumab, ustkinumab, or other biotherapy (e.g. risankizumab) * Patient able to understand, write and read French Exclusion Criteria: * The patient is participating in an interventional study * The patient is under safeguard of justice or state guardianship * Medical treatment other than biotherapies including anti-TNF α (infliximab or adalimumab), vedolizumab, ustkinumab, risankinumab * Contraindication to surgery, such as major cardiovascular comorbidities * Pregnant, breast-feeding or parturient women
Locations (2)
| Site | City | Country | Site status |
|---|---|---|---|
| CHU de Montpellier Hôpital St Eloi | Montpellier | France | Recruiting |
| CHU de Nîmes | Nîmes | France | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.