Clinical trial NCT06856044: Safety of Mesentery-embedding Surgery in Patients With Ileocolic Crohn's Disease on Biotherapy
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Crohn Disease
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2025-03-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.


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

Primary outcomes:
measure: Post-surgical complication rate
timeFrame: 30 days after surgery
Secondary outcomes:
measure: Postoperative endoscopic recurrence
timeFrame: 6 months
measure: Surgical time of the ileocolic resection technique
timeFrame: End of surgery
measure: Intraoperative bleeding
timeFrame: End of surgery
measure: Length of hospital stay
timeFrame: End of hospitalization (max 1 month)
measure: Presence of intra- and post-operative complications
timeFrame: Immediately following surgery
measure: Number of intra- and post-operative complications
timeFrame: Immediately following surgery
measure: Time until resumption of transit following surgery
timeFrame: Following surgery (maximum 5 days)
measure: Time until resumption of eating
timeFrame: Following surgery (average 1 day)
measure: Presence of myenteric plexitis with at least one inflammatory cell at proximal ileal resection margin
timeFrame: Immediately following surgery
measure: Number of lymph nodes in the histological specimen
timeFrame: Immediately following surgery
measure: Resection not in healthy margin
timeFrame: Immediately following surgery
measure: Length of resected digestive tract
timeFrame: Immediately following surgery
measure: Area of mesentery removed
timeFrame: Immediately following surgery
measure: C-reactive protein level
timeFrame: Day before surgery
measure: C-reactive protein level
timeFrame: Day 2
measure: C-reactive protein level
timeFrame: Day 4
measure: C-reactive protein level
timeFrame: Month 1
measure: C-reactive protein level
timeFrame: Month 6
measure: Albuminemia
timeFrame: Day before surgery
measure: Hemoglobinemia
timeFrame: Day before surgery
measure: Hemoglobinemia
timeFrame: Day 2
measure: Hemoglobinemia
timeFrame: Day 4
measure: White blood cells
timeFrame: Day before surgery
measure: White blood cells
timeFrame: Day 2
measure: White blood cells
timeFrame: Day 4
measure: Fecal calprotectin
timeFrame: Month 6
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHU de Montpellier Hôpital St Eloi
city: Nîmes
country: France
facility: CHU de Nîmes
Study officials:
affiliation: CHU de Nimes
name: Martin BERTRAND
role: PRINCIPAL_INVESTIGATOR
References: