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

July 26, 2023 updated by: Centre Hospitalier Departemental Vendee

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

1100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Angers, France
        • Recruiting
        • CHU Angers
        • Principal Investigator:
          • Stéphanie MUSSI, PH
      • Cesson-Sévigné, France
        • Recruiting
        • Hopital privé de Sévigné
        • Principal Investigator:
          • Christine TISSON, PH
      • Challans, France, 85300
        • Recruiting
        • CH de Challans
        • Principal Investigator:
          • Marion CHARVIN, PH
      • Cholet, France, 49300
        • Recruiting
        • CH de Cholet 1 rue Marengo
        • Principal Investigator:
          • François RADE, PH
      • Fougères, France, 35300
        • Recruiting
        • Centre Hospitalier de Fougères
        • Principal Investigator:
          • Emmanuel NAUDEIX, PH
      • La Roche sur Yon, France, 85925
        • Recruiting
        • CHD Vendee
        • Principal Investigator:
          • Emeric ABET, PH
      • La Rochelle, France
        • Recruiting
        • Centre Hospitalier de La Rochelle
        • Principal Investigator:
          • Pierre-Yves LEFANT, PH
      • Le Mans, France
        • Recruiting
        • Centre Hospitalier du Mans
        • Principal Investigator:
          • Julien BARBIEUX, PH
      • Lorient, France, 56324
        • Recruiting
        • Clinique Mutualiste de la Porte de l'Orient
        • Principal Investigator:
          • Guillaume LEROUX, PH
      • Nantes, France, 44093
        • Recruiting
        • CHU de Nantes
        • Principal Investigator:
          • Emilie DUCHALAIS, PH
      • Plérin, France
        • Recruiting
        • Hopital Privé des Cotes d'Armor
        • Principal Investigator:
          • Corentin DUFAY, PH
      • Rennes, France
        • Recruiting
        • Clinique La Sagesse
        • Principal Investigator:
          • Philippe METZLER, PH
      • Saint-Brieuc, France
        • Recruiting
        • Centre Hospitalier de Saint Brieuc
        • Principal Investigator:
          • Laetitia COURTIN TANGUY, PH
      • Saint-Nazaire, France, 44600
        • Recruiting
        • Clinique Mutualiste de l'Estuaire
        • Principal Investigator:
          • Florent JURCZAK, PH
      • Vannes, France, 56017
        • Recruiting
        • Centre Hospitalier Bretagne Atlantique
        • Principal Investigator:
          • Thimothée THIEBOT, PH
      • Vannes, France
        • Not yet recruiting
        • Hôpital Privé Océane
        • Principal Investigator:
          • Guillaume BOULANGER, PH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patient admitted for right colectomy in one of the 6 hospitals or clinics.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Right colectomy
Patient with scheduled right colectomy and with a documented preoperative scan.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total calcification score associated with the occurrence of anastomotic leakage
Time Frame: 6 weeks after surgery

Sum of the calcification scores of the following 4 segments (≥3) associated with the occurrence of anastomotic leakage within 6 weeks postoperatively.

4 segments:

  • Ostium of celiac artery
  • Ostium of superior mesenteric artery
  • first segment of superior mesenteric artery
  • distal segment of superior mesenteric artery Each segment will be assigned a score between 0 and 2. Total score range : 0-8
6 weeks after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Calcification score of each segment associated with the occurrence of anastomotic leakage
Time Frame: 6 weeks after surgery

4 segments:

  • Ostium of celiac artery
  • Ostium of superior mesenteric artery
  • first segment of superior mesenteric artery
  • distal segment of superior mesenteric artery Each segment will be assigned a score between 0 and 2.
6 weeks after surgery
Morbidities defined according to Clavien-Dindo classification
Time Frame: 6 weeks after surgery
Morbidities defined according to Clavien-Dindo classification occurring at 6 weeks postoperatively
6 weeks after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Emeric ABET, CHD Vendee

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 24, 2019

Primary Completion (Estimated)

November 10, 2025

Study Completion (Estimated)

November 10, 2025

Study Registration Dates

First Submitted

June 27, 2019

First Submitted That Met QC Criteria

June 28, 2019

First Posted (Actual)

July 1, 2019

Study Record Updates

Last Update Posted (Actual)

July 27, 2023

Last Update Submitted That Met QC Criteria

July 26, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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