Risk Factors of Complications After Ileocolic Resection f... | NCT03846778

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

NCT03846778

Sponsor

University Hospital, Montpellier

Status

Completed

Last Update Posted

Dec 29, 2020Actual

Enrollment

200Actual

Phase

Not provided

Conditions

Crohn Disease
Ileocolic Resection

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2019Actual

Primary Completion Date

Mar 1, 2020Actual

Completion Date

Sep 1, 2020Actual

First Submitted Date

Feb 15, 2019

First Submission Date that Met QC Criteria

Feb 15, 2019

First Posted Date

Feb 20, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 28, 2020

Last Update Posted Date

Dec 29, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

200Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients requiring an ileocolic resection for Crohn disease

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
REGIS SOUCHE	University Hospital, Montpellier	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Uhmontpellier		Montpellier		34295	France

Condition Browse Module

MeSH Terms

ID	Term
D003424	Crohn Disease
D011183	Postoperative Complications

Ancestor Terms

ID	Term
D015212	Inflammatory Bowel Diseases
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Description

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.