Evaluation of an Arterial Calcification Score as a Predictive Factor of Anastomotic Leakage in Right Colectomy

NCT ID: NCT04002921

Last Updated: 2025-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

615 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-24

Study Completion Date

2025-11-18

Brief Summary

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Anastomotic leakage is the major postoperative complication in right colectomy. Evaluation of calcification on coeliac trunk and mesenteric arteries on the preoperative CT scan could allow the identification of patient at-risk of postoperative complications.

A monocentric retrospective study performed at CHD Vendée concluded than a calcification score over or equal to 3 was associated with a higher risk of developping an anastomotic leakage.

The aim of this prospective multicentric study is to validate a calcification score based on preoperative CT scan analysis and focussing at coeliac trunk and mesenteric arteries.This study will involve patients operated on with a scheduled right colectomy.

Detailed Description

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Conditions

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Right Colectomy

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Right colectomy

Patient with scheduled right colectomy and with a documented preoperative scan.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 years old
* Scheduled right colectomy with restoration of digestive continuity
* Patient who has had or will have a preoperative abdominal-pelvic CT scan with or without contrast injection
* Patient with the ability to understand the protocol and agree to participate in the study.
* Affiliated with a social security system

Exclusion Criteria

* Patient requiring a right colectomy or ileocaecal resection for chronic inflammatory bowel disease or on long-term corticosteroid therapy
* Patient with a history of colic resection
* Patient under guardianship, curatorship, or deprived of liberty
* Pregnant, postpartum or breastfeeding women
* Minor patients
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Departemental Vendee

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emeric ABET

Role: PRINCIPAL_INVESTIGATOR

CHD Vendée

Locations

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CHU Angers

Angers, , France

Site Status

Hopital privé de Sévigné

Cesson-Sévigné, , France

Site Status

CH de Challans

Challans, , France

Site Status

CH de Cholet 1 rue Marengo

Cholet, , France

Site Status

Centre Hospitalier de Fougères

Fougères, , France

Site Status

CHD Vendée

La Roche-sur-Yon, , France

Site Status

Centre Hospitalier du Mans

Le Mans, , France

Site Status

Clinique Mutualiste de la Porte de l'Orient

Lorient, , France

Site Status

CHU de Nantes

Nantes, , France

Site Status

Centre Hospitalier de Saint Brieuc

Saint-Brieuc, , France

Site Status

Clinique Mutualiste de l'Estuaire

Saint-Nazaire, , France

Site Status

Centre Hospitalier Bretagne Atlantique

Vannes, , France

Site Status

Countries

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France

Other Identifiers

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CHD 086-19

Identifier Type: -

Identifier Source: org_study_id

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