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Completed

NCT Number: NCT06299631

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

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

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Montpellier University Hospital

Montpellier, 34295, France

About this study

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.

Who can participate

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

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

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

Treatment and study plan

ileocolic resection

Procedure

Ileocolic resection by open or laparoscopic approach

Primary outcomes

  1. Endoscopic recurrence rate

    Time frame: 6 months after surgery

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

Secondary outcomes

  1. Resection margins

    Time frame: 90 days after surgery

    Pathological examination of resection margins

  2. Length of resected specimen

    Time frame: 90 days after surgery

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

  3. Duration of surgery

    Time frame: 90 days after surgery

    Operative time

  4. Intra-operative blood loss

    Time frame: 90 days after surgery

    Intra-operative blood losss

  5. Postoperative morbidity rate

    Time frame: 90 days after surgery

    Postoperative morbidity according to Clavien Dindo

  6. Mortality rate

    Time frame: 90 days after surgery

    Death occuring within 90 days after surgery

  7. Myenteric plexitis

    Time frame: 90 days after surgery

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

  8. Number of inflammatory cells in myenteric plexuses

    Time frame: 90 days after surgery

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

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Collaborators

  • Carémeau University Hospital, Nîmes

Registry information

Official study title

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

Acronym: RIC-1

Important dates

Study start
2015
Primary completion
2023
Study completion
2023
First posted
Mar 8, 2024
Registry last updated
Mar 8, 2024

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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