Safety of Mesentery-embedding Surgery in Patients With Ileocolic Crohn's Disease on Biotherapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ileocolic resection with extended mesenteric resection.
- Who it may be relevant to
- Registry conditions: Crohn Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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. Mesentery resection has encouraging results on recurrence requiring reoperation, with a reduction of over 30% in recurrences compared with the standard technique. The study authors wish to evaluate the safety of ileocolic resection surgery involving the mesentery in patients with Crohn's disease treated with biotherapy. The study hypothesis is that mesentery surgery is no more risky than conventional (gold standard) surgery, and reduces the 6-month endoscopic recurrence rate in patients with ileocolic Crohn's disease on biotherapy requiring ileocolic resection.
Interventions
- Procedure ileocolic resection with extended mesenteric resection
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.
Primary outcome measures
- Post-surgical complication rate [Time frame: 30 days after surgery]
Secondary outcome measures (12)
- Postoperative endoscopic recurrence [Time frame: 6 months]
- Surgical time of the ileocolic resection technique [Time frame: End of surgery]
- Intraoperative bleeding [Time frame: End of surgery]
- Length of hospital stay [Time frame: End of hospitalization (max 1 month)]
- Presence of intra- and post-operative complications [Time frame: Immediately following surgery]
- Number of intra- and post-operative complications [Time frame: Immediately following surgery]
- Time until resumption of transit following surgery [Time frame: Following surgery (maximum 5 days)]
- Time until resumption of eating [Time frame: Following surgery (average 1 day)]
- Presence of myenteric plexitis with at least one inflammatory cell at proximal ileal resection margin [Time frame: Immediately following surgery]
- Number of lymph nodes in the histological specimen [Time frame: Immediately following surgery]
- Resection not in healthy margin [Time frame: Immediately following surgery]
- Length of resected digestive tract [Time frame: Immediately following surgery]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 2 centers
- CHU de Montpellier Hôpital St Eloi — Montpellier
- CHU de Nîmes — Nîmes
Identifiers
NCT: NCT06856044 · NIMAO/2023-2/MB-01