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

• ClinicalTrials.gov Identifier: NCT03846778
• Recruitment Status: Completed
• First Posted: February 20, 2019
• Last Update Posted: December 29, 2020
• Sponsor: University Hospital, Montpellier
• Information provided by (Responsible Party): University Hospital, Montpellier

Study Description

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.

Condition or disease
Crohn Disease; Ileocolic Resection

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 200 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Risk Factors of Complications After Ileocolic Resection for Crohn Disease According to the Comprehensive Complication Index - RICCI
• Actual Study Start Date: January 1, 2019
• Actual Primary Completion Date: March 1, 2020
• Actual Study Completion Date: September 1, 2020

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. Comprehensive Complication Index [ Time Frame: 90 days (after surgery) ]
   Comprehensive Complication Index (CCI)

Secondary Outcome Measures :

1. Morbidity according to the Clavien Dindo Classification [ Time Frame: 90 days (after surgery) ]
   Morbidity according to the Clavien Dindo Classification
2. Mortality [ Time Frame: 90 days (after surgery) ]
   Mortality
3. Reoperation rate [ Time Frame: 90 days (after surgery) ]
   Reoperation rate
4. Readmission rate [ Time Frame: 90 days (after surgery) ]
   Readmission rate

Biospecimen Retention:   None Retained

Cytolyt Samples:

Liquid conservation samples from patients who underwent endoscopic ultrasound with fine needle aspiration/biopsy for suspicious pancreatic mass at the CHU de Montpellier were conserved at +4°c.

Cytolyt samples do not contain any cell or tissue from patient, this liquid is systematically trashed in current practice. No genetics analysis will be performed from these particular samples in the present study.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

patients requiring an ileocolic resection for Crohn disease

Criteria

Inclusion criteria:

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

Exclusion Criteria:

- Patient who reject the study protocol

Contacts and Locations

Locations

France

Uhmontpellier

Montpellier, France, 34295

Sponsors and Collaborators

University Hospital, Montpellier

Investigators

• Study Director: REGIS SOUCHE; University Hospital, Montpellier

More Information

• Responsible Party: University Hospital, Montpellier
• ClinicalTrials.gov Identifier: NCT03846778
• Other Study ID Numbers: RECHMPL19_0050
• First Posted: February 20, 2019
• Last Update Posted: December 29, 2020
• Last Verified: December 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Montpellier:

Postoperative outcomes; Laparoscopy; Comprehensive complication index; Postoperative complications

Additional relevant MeSH terms:

Crohn Disease; Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases