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

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: Completed
• Conditions: Right Colectomy

• Study Type: Observational
• Enrollment (Actual): 615

Contacts and Locations

Study Locations

• France
  • Angers, France
    • CHU Angers
  • Cesson-Sévigné, France
    • Hôpital Privé de Sévigné
  • Challans, France, 85300
    • CH de Challans
  • Cholet, France, 49300
    • CH de Cholet 1 rue Marengo
  • Fougères, France, 35300
    • Centre Hospitalier de Fougères
  • La Roche-sur-Yon, France, 85925
    • CHD Vendée
  • Le Mans, France
    • Centre Hospitalier du Mans
  • Lorient, France, 56324
    • Clinique Mutualiste de la Porte de l'Orient
  • Nantes, France, 44093
    • CHU de Nantes
  • Saint-Brieuc, France
    • Centre Hospitalier de Saint Brieuc
  • Saint-Nazaire, France, 44600
    • Clinique mutualiste de l'Estuaire
  • Vannes, France, 56017
    • Centre Hospitalier Bretagne Atlantique

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

1

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	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	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	Morbidities defined according to Clavien-Dindo classification occurring at 6 weeks postoperatively	6 weeks after surgery

Collaborators and Investigators

• Sponsor: Centre Hospitalier Departemental Vendee
• Investigators: Principal Investigator: Emeric ABET, CHD Vendée

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2019
• Primary Completion (Actual): November 18, 2025
• Study Completion (Actual): November 18, 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 (Estimated): December 4, 2025
• Last Update Submitted That Met QC Criteria: November 27, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: calcification; anastomotic leakage; right colectomy
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Metabolic Diseases; Calcium Metabolism Disorders; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Anastomotic Leak; Calcinosis
• Other Study ID Numbers: CHD 086-19

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No