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

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

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.

Study Overview

• Status: Completed
• Conditions: 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 Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • Uhmontpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients requiring an ileocolic resection for Crohn disease

Description

Inclusion criteria:

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

Exclusion Criteria:

- Patient who reject the study protocol

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comprehensive Complication Index	Comprehensive Complication Index (CCI)	90 days (after surgery)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morbidity according to the Clavien Dindo Classification	Morbidity according to the Clavien Dindo Classification	90 days (after surgery)
Mortality	Mortality	90 days (after surgery)
Reoperation rate	Reoperation rate	90 days (after surgery)
Readmission rate	Readmission rate	90 days (after surgery)

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): March 1, 2020
• Study Completion (Actual): September 1, 2020

Study Registration Dates

• First Submitted: February 15, 2019
• First Submitted That Met QC Criteria: February 15, 2019
• First Posted (Actual): February 20, 2019

Study Record Updates

• Last Update Posted (Actual): December 29, 2020
• Last Update Submitted That Met QC Criteria: December 28, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Postoperative complications; Laparoscopy; Postoperative outcomes; Comprehensive complication index
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: RECHMPL19_0050

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No