Clinical trial NCT03846778: Risk Factors of Complications After Ileocolic Resection for Crohn Disease According to the Comprehensive Complication Index
Official title: Risk Factors of Complications After Ileocolic Resection for Crohn Disease According to the Comprehensive Complication Index - RICCI
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn Disease
Ileocolic Resection
Keywords: Postoperative outcomes
Laparoscopy
Comprehensive complication index
Postoperative complications
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2019-02-20
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients requiring an ileocolic resection for Crohn disease

Brief summary: Aim: The aim of this study was to investigate the risks factors of complications after ileocolic resection for Crohn disease according to the comprenhensive complication index.

Methods: Data collected between January 2010 and March 2020 will be analyzed. Informations about preoperative, peroperative and post operative will be collected. The outcome after surgery will be analysed according to the comprehensive complication index.

Detailed description: There are several risk factors reported for postoperative complication after ileocolic resection for Crohn disease. With recent new therapeutics (anti TNF, monoclonal antibodies), these criteria are questioned.

According to the ECCO 2010 Consensus Conference, five post-operative risk factors for recurrence of Crohn disease were described: smoking, extensive small bowel resection (\> 50cm), repeat bowel resection, presence of ano-perineal lesions, and penetrating disease (type B3). However, postoperative complication risk factors after ileocolic resection remain debated. Currently the place of a pre-operative treatment with anti-TNF seems to be a post-operative complication risk factor according to the last ECCO 2017 consensus conference, as well as preoperative parenteral nutrition and emergency versus planned surgery. In addition, a recent GETAID study seems to challenge the penetrating phenotype as a risk factor of postoperative complication. A current study could provide new data on the various known or suspected complication risk factors in the anti-TNF/monoclonal antibodies era.

The classification of Clavien Dindo does not necessarily take into account the respective severities of each complication in a patients. The new classification (Comprehensive Complication Index (CCI)) could be usefull to take into account all the complications and their importance, without focusing only on the most important. To our knowledge, there is no study specifically evaluating CCI after ileocolic resection for Crohn disease. We believe that the CCI can provide a more refined analysis of risk factors for postoperative complications after this procedure.

The aim of this study is to analyze the different complication risk factors after ileocecal resection according to the recent Comprehensive Complication Index, tools potentially more sensitive than Clavien Dindo classification to highlight differences in postoperative morbidity.

Eligibility criteria: Inclusion criteria:

* Patients who underwent an ileocolic resection for Crohn disease
* Patient ≥18 years old

Exclusion Criteria:

- Patient who reject the study protocol

Primary outcomes:
measure: Comprehensive Complication Index
timeFrame: 90 days (after surgery)
Secondary outcomes:
measure: Morbidity according to the Clavien Dindo Classification
timeFrame: 90 days (after surgery)
measure: Mortality
timeFrame: 90 days (after surgery)
measure: Reoperation rate
timeFrame: 90 days (after surgery)
measure: Readmission rate
timeFrame: 90 days (after surgery)
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: REGIS SOUCHE
role: STUDY_DIRECTOR
References: