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NCT Number: NCT03846778

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

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.

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Key information

Conditions

Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Ileocolic Resection Inflammatory Bowel Diseases Intestinal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Uhmontpellier

Montpellier, 34295, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patient who reject the study protocol

Treatment and study plan

Primary outcomes

  1. Comprehensive Complication Index

    Time frame: 90 days (after surgery)

    Comprehensive Complication Index (CCI)

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Acronym: RICCI

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 20, 2019
Registry last updated
Dec 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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