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NCT Number: NCT06856044

Safety of Mesentery-embedding Surgery in Patients With Ileocolic Crohn's Disease on Biotherapy

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Montpellier Hôpital St Eloi, Montpellier, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Post-surgical complication rate

    Time frame: 30 days after surgery

    Percentage, graded according to the Clavien-Dindo Classification

Secondary outcomes

  1. Postoperative endoscopic recurrence

    Time frame: 6 months

    Yes/No according to Rutgeerts classification (i0-i4), using a cut-off score ≥ i2

  2. Surgical time of the ileocolic resection technique

    Time frame: End of surgery

    Minutes

  3. Intraoperative bleeding

    Time frame: End of surgery

    If yes, volume (ml)

  4. Length of hospital stay

    Time frame: End of hospitalization (max 1 month)

    Days

  5. Presence of intra- and post-operative complications

    Time frame: Immediately following surgery

    Yes/no

  6. Number of intra- and post-operative complications

    Time frame: Immediately following surgery

    Number

  7. Time until resumption of transit following surgery

    Time frame: Following surgery (maximum 5 days)

    Number of days between surgery and resumption of transit

  8. Time until resumption of eating

    Time frame: Following surgery (average 1 day)

    Number of days between surgery and resumption of eating

  9. Presence of myenteric plexitis with at least one inflammatory cell at proximal ileal resection margin

    Time frame: Immediately following surgery

    Classed as: Absent; 1-3 inflammatory cells; 4-9; or 10+

  10. Number of lymph nodes in the histological specimen

    Time frame: Immediately following surgery

    Number

  11. Resection not in healthy margin

    Time frame: Immediately following surgery

    (Yes/No)

  12. Length of resected digestive tract

    Time frame: Immediately following surgery

    Centimeters

  13. Area of mesentery removed

    Time frame: Immediately following surgery

    Square centimeters

  14. C-reactive protein level

    Time frame: Day before surgery

  15. C-reactive protein level

    Time frame: Day 2

  16. C-reactive protein level

    Time frame: Day 4

  17. C-reactive protein level

    Time frame: Month 1

  18. C-reactive protein level

    Time frame: Month 6

  19. Albuminemia

    Time frame: Day before surgery

  20. Hemoglobinemia

    Time frame: Day before surgery

  21. Hemoglobinemia

    Time frame: Day 2

  22. Hemoglobinemia

    Time frame: Day 4

  23. White blood cells

    Time frame: Day before surgery

  24. White blood cells

    Time frame: Day 2

  25. White blood cells

    Time frame: Day 4

  26. Fecal calprotectin

    Time frame: Month 3

Study contacts

Contact information is provided by the study sponsor or research team.

Martin BERTRAND

CONTACT

[email protected]

04 66 68 31 43

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study 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

Acronym: RIC-2

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Mar 4, 2025
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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