Endoscopic Relapse Risks Evaluation After Ileocolic Resection for Crohn's Disease

NCT06299631 | Completed

• 1 other identifier: RECHMPL23_0187
• Study Type: observational
• Target: 133
• Locations: 1 country
• Sites: 1

Brief Summary

Aim of the study: To evaluate risk factors of endoscopic relapse after ileocolic resection in a cohort of Crohn's disease patients treated with anti-TNF agents. Methods: From 2014 to 2022, all consecutive patients who underwent ileocolic resection for Crohn's disease treated with anti-TNF agents in two referral tertiary center were prospectively collected. Considering exclusion criteria, data from 114 patients were analyzed. The cohort was separated into 2 groups according to study period. Short and long-term outcomes were compared between the two groups. Primary outcome: Endoscopic recurrence (defined as \> i2 lesions according to Rutgeerts classification) 6 months after surgery

Conditions

Crohn's Disease

Outcome Measures

Primary Outcomes (1)

• Endoscopic recurrence rate

  Defined as the presenc of new mucosal lesions classified \>i2 according to Rutgeerts classification.

  6 months after surgery

Secondary Outcomes (8)

• Resection margins

  90 days after surgery

• Length of resected specimen

  90 days after surgery

• Duration of surgery

  90 days after surgery

• Intra-operative blood loss

  90 days after surgery

• Postoperative morbidity rate

  90 days after surgery

Study Arms (1)

Crohn's disease patients undergoing ICR

Crohn's disease patients undergoing ICR treated with TNF inhibitors

Procedure: Ileocolic resection

Interventions

Ileocolic resection PROCEDURE

Ileocolic resection by open or laparoscopic approach

Crohn's disease patients undergoing ICR

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with Crohn's disease treated with TNF inhibitors who underwent ileocolic resection between 2014 and 2023 in the Digestive Surgery (A), Oncology and Minimally Invasive Department (Pr FABRE) of the Montpellier University Hospital and the Digestive Surgery and Cancer Department (Pr PRUDHOMME) of the Nimes University Hospital

You may qualify if:

• Patients with histologically proven Crohn's disease
• On anti-TNF alpha: infliximab, adalimumab (ECCO 2014 recommendation)
• \> 18 years old patients
• All patients who have undergone ileocolic resection and whose disease site is accessible to endoscopic follow-up (first or repeat procedure)

You may not qualify if:

• Minor patients under 18 years of age
• Endoscopic follow-up not possible
• Pregnant women
• Medical treatment other than anti-TNF alpha

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• Carémeau University Hospital, Nîmes: collaborator

Study Sites (1)

Montpellier University Hospital

Montpellier, 34295, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

pathology sections blood sample

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Thomas BARDOL, MD, MSc

  Montpellier University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2023
• First Posted: March 8, 2024
• Study Start: January 1, 2015
• Primary Completion: June 1, 2023
• Study Completion: December 1, 2023
• Last Updated: March 8, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)