Risk Factors of Complications After Ileocolic Resection for Crohn Disease According to the Comprehensive Complication Index

Crohn Disease Clinical Trial

— RICCI  

Official title:

Risk Factors of Complications After Ileocolic Resection for Crohn Disease According to the Comprehensive Complication Index - RICCI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03846778
• Other study ID #: RECHMPL19_0050
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: September 1, 2020

Study information

• Verified date: December 2020
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Patients who underwent an ileocolic resection for Crohn disease
• Patient =18 years old

Exclusion Criteria:

• Patient who reject the study protocol

Related Conditions & MeSH terms

• Crohn Disease
• Ileocolic Resection

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comprehensive Complication Index	Comprehensive Complication Index (CCI)	90 days (after surgery)
Secondary	Morbidity according to the Clavien Dindo Classification	Morbidity according to the Clavien Dindo Classification	90 days (after surgery)
Secondary	Mortality	Mortality	90 days (after surgery)
Secondary	Reoperation rate	Reoperation rate	90 days (after surgery)
Secondary	Readmission rate	Readmission rate	90 days (after surgery)