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
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
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:
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.
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 →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.
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
Exclusion Criteria:
Crohn's disease patients undergoing ICR treated with TNF inhibitors
Procedure: Ileocolic resection
Ileocolic resection by open or laparoscopic approach
Endoscopic recurrence rate
Defined as the presenc of new mucosal lesions classified \>i2 according to Rutgeerts classification.
Time frame: 6 months after surgery
Resection margins
Pathological examination of resection margins
Time frame: 90 days after surgery
Length of resected specimen
Pathological examination and measure of the lenght of ileon and colon resection
Time frame: 90 days after surgery
Duration of surgery
Operative time
Time frame: 90 days after surgery
Intra-operative blood loss
Intra-operative blood losss
Time frame: 90 days after surgery
Postoperative morbidity rate
Postoperative morbidity according to Clavien Dindo
Time frame: 90 days after surgery
Mortality rate
Death occuring within 90 days after surgery
Time frame: 90 days after surgery
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
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
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Hospital, Montpellier