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Crohn's DiseaseRIC-1NCT06299631

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

An observational study of Crohn's Disease, run by University Hospital, Montpellier at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Crohn's Disease
What is being tested?
Ileocolic resection
Type of treatment
Surgery or procedure
How many people
133 participants
Where
1 siteFrance
Study dates
Jan 2015to Dec 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • Adult, Older adult

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

Who may be able to join

  • 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)

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

France1 site
  • Montpellier University Hospital

    Montpellier, 34295

Other trials in France

About this study

Official title: Endoscopic Relapse Risk Factors After Ileocolic Resection on Crohn's Disease Patients in the Biologic Era

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.

Conditions
Crohn's Disease
Being tested
Ileocolic resection
Medical subject headings
Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ileocolic resectionProcedure or surgery

    Ileocolic resection by open or laparoscopic approach

Study groups in NCT06299631
Study groupRoleWhat they receive
Crohn's disease patients undergoing ICRCrohn's disease patients undergoing ICR treated with TNF inhibitors
Receives: Procedure: Ileocolic resection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Endoscopic recurrence rate

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

    Measured: 6 months after surgery

Secondary outcomes (8)
  1. Resection margins

    Pathological examination of resection margins

    Measured: 90 days after surgery

  2. Length of resected specimen

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

    Measured: 90 days after surgery

  3. Duration of surgery

    Operative time

    Measured: 90 days after surgery

  4. Intra-operative blood loss

    Intra-operative blood losss

    Measured: 90 days after surgery

  5. Postoperative morbidity rate

    Postoperative morbidity according to Clavien Dindo

    Measured: 90 days after surgery

  6. Mortality rate

    Death occuring within 90 days after surgery

    Measured: 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

    Measured: 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

    Measured: 90 days after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Mar 2024
  2. Study startJan 2015
  3. Primary completionJun 2023
  4. Study completionDec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
133 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06299631
Sponsor's protocol ID
RECHMPL23_0187
Acronym
RIC-1
Status last verified
Nov 2023
First submitted
29 Nov 2023
Last updated
8 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Crohn's Disease, run by University Hospital, Montpellier at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Endoscopic recurrence rate (time frame: 6 months after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2024; AzTrials last refreshed its copy on 1 Nov 2026.

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