Crohn Disease
Conditions
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.
Interventions
PROCEDUREileocolic 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.
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-surgical complication rate | 30 days after surgery | Percentage, graded according to the Clavien-Dindo Classification |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobinemia | Day before surgery | — |
| White blood cells | Day before surgery | — |
| Fecal calprotectin | Month 3 | — |
| Time until resumption of eating | Following surgery (average 1 day) | Number of days between surgery and resumption of eating |
| Presence of myenteric plexitis with at least one inflammatory cell at proximal ileal resection margin | Immediately following surgery | Classed as: Absent; 1-3 inflammatory cells; 4-9; or 10+ |
| Number of lymph nodes in the histological specimen | Immediately following surgery | Number |
| Resection not in healthy margin | Immediately following surgery | (Yes/No) |
| Length of resected digestive tract | Immediately following surgery | Centimeters |
| Area of mesentery removed | Immediately following surgery | Square centimeters |
| Postoperative endoscopic recurrence | 6 months | Yes/No according to Rutgeerts classification (i0-i4), using a cut-off score ≥ i2 |
| Surgical time of the ileocolic resection technique | End of surgery | Minutes |
| Intraoperative bleeding | End of surgery | If yes, volume (ml) |
| Length of hospital stay | End of hospitalization (max 1 month) | Days |
| Presence of intra- and post-operative complications | Immediately following surgery | Yes/no |
| Number of intra- and post-operative complications | Immediately following surgery | Number |
| Time until resumption of transit following surgery | Following surgery (maximum 5 days) | Number of days between surgery and resumption of transit |
| Albuminemia | Day before surgery | — |
| C-reactive protein level | Day before surgery | — |
Countries
France
Contacts
CONTACTMartin BERTRAND
PRINCIPAL_INVESTIGATORMartin BERTRAND
CHU de Nimes
Outcome results
None listed