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CompletedNCT06299631RIC-1Updated Mar 8, 2024

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

An observational study in Crohn's Disease, sponsored by University Hospital, Montpellier. Completed at 1 site in France. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2024-03-08.

Sponsored by University Hospital, Montpellier · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
133
Ages
18 Years to 99 Years
Sex
All
01

Study 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

Read the detailed description

Crohn's disease is a chronic inflammatory bowel disease whose preferential location is the ileo-colon, for which surgical management is necessary in 60% of patients.

The most common surgical procedure is ileo-caecal resection for symptomatic last ileal loop stenosis resistant to a well conducted medical treatment.

The conventional surgical technique aims to preserve the length of the digestive tract as much as possible. From a technical point of view, the resection passes as close as possible to the small intestine, leaving the vessels within the mesentery in place.

Despite the improvement of therapeutics (over the last decade, 80% of patients present an endoscopic recurrence at 1 year after surgery. Endoscopic recurrence is defined as the apparition of new typical mucosal lesions based on the Rutgeerts classification.

According to the last ECCO guidelines, biologic agents (TNF-inhibitors, ustekinumab and vedolizumab) are used as maintenance treatment in moderate-to-severe Crohn's disease patients:

  • who achieved remission with anti-TNF agents -> maintenance treatment using the same treatment.
  • who have achieved long-term remission with the combination of infliximab and immunosuppressants -> monotherapy with infliximab.
  • who have achieved long-term remission with the combination of adalimumab and immunosuppressants -> monotherapy with adalimumab. The risk factors for postoperative recurrence are now well established and include smoking habit, penetrating or fistulizing phenotype (classified as B3 in the Montréal classification), perineal disease, history of previous bowel resection, extensive small bowel resection (>20 cm).

Recently, the role of the mesentery in Crohn's disease has been deeply investigated. There is a mesenteric nerve dysfunction with inhibition of anti-inflammatory activity, a major angiogenesis, a multiplication of lymphatic vessels with emboli at the origin of lymphatic drainage abnormalities, a mesenteric hypertrophy with multiple small adipocytes secreting adipokines.

These new elements have raised the question of a potential benefit of a combined resection of the mesentery during an ileocecal resection in the treatment of Crohn's disease.

CALVIN J Coffrey et al. carried out a study in 2008 comparing a prospective cohort with ileo-caecal resection including the mesentery (mesentery resection group) to a retrospective cohort with classical ileocecal resections (ICR group). The results were very promising in terms of recurrence requiring surgical management with a re-operation rate at 5 years of 40% in the classical ICR group vs 2.9% in the mesenteric resection group. And shows that significant mesenteric disease is an independent risk factor for recurrence with a HR=4.7 (p\<0.007).

Thus, it is necessary to analyse within local patient base: the percentage of endoscopic recurrence at 6 months after surgery in patients treated with anti TNFa as well as the risk factors at the origin of the increase of these recurrences, more particularly the anatomopathological factors which could call into question the surgical practices within the long term a major interest in resection of the mesentery.

Therefore, the investigator carried out a retrospective study in two referral tertiary center, Montpellier University Hospital and Nîmes University Hospital. The investigator prospectively collected data from 2014 to 2022 from Crohn's disease patients treated with TNF inhibitors who have undergone ileocolic resection, to determine the percentage of endoscopic recurrence at 6 months and its risk factors.

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Conditions studied

  • Crohn's Disease

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In context

Crohn Disease

1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.

This study's enrollment of 133 is below the median of 162 across 608 observational studies indexed under Crohn Disease.

Browse Crohn Disease studies →

Lead sponsor

University Hospital, Montpellier is the lead sponsor of 1,244 studies on the registry; 225 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
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

Inclusion criteria

  • 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)

Exclusion criteria

Exclusion Criteria:

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

Observational model
Case-only
Time perspective
Prospective
Enrollment
133 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Crohn's disease patients undergoing ICR

    Crohn's disease patients undergoing ICR treated with TNF inhibitors

    Procedure: Ileocolic resection

Interventions

  • ProcedureIleocolic resection

    Ileocolic resection by open or laparoscopic approach

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What researchers measure

Primary outcomes

  1. Endoscopic recurrence rate

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

    Time frame: 6 months after surgery

Secondary outcomes

  1. Resection margins

    Pathological examination of resection margins

    Time frame: 90 days after surgery

  2. Length of resected specimen

    Pathological examination and measure of the lenght of ileon and colon resection

    Time frame: 90 days after surgery

  3. Duration of surgery

    Operative time

    Time frame: 90 days after surgery

  4. Intra-operative blood loss

    Intra-operative blood losss

    Time frame: 90 days after surgery

  5. Postoperative morbidity rate

    Postoperative morbidity according to Clavien Dindo

    Time frame: 90 days after surgery

  6. Mortality rate

    Death occuring within 90 days after surgery

    Time frame: 90 days after surgery

  7. Myenteric plexitis

    Myenteric plexitis defined as the presence of \> 3 inflammatory cells in myenteric plexuses of the proximal resection margin

    Time frame: 90 days after surgery

  8. Number of inflammatory cells in myenteric plexuses

    Number of inflammatory cells in myenteric plexuses of inflammatory cells in myenteric plexuses

    Time frame: 90 days after surgery

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Study locations

1 site
  • Montpellier University Hospital
    Montpellier, 34295, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06299631
Lead sponsor
University Hospital, Montpellier
Collaborators
Carémeau University Hospital, Nîmes
Responsible party
Sponsor
First posted
Mar 8, 2024
Start date
Jan 2015
Primary completion
Jun 2023
Completion
Dec 2023
Last update
Mar 8, 2024

Study contacts

Thomas BARDOL, MD, MSc
principal investigator · Montpellier University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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