NCT04002921

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
615

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2019

Longer than P75 for all trials

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 1, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

September 24, 2019

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 18, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 18, 2025

Completed
Last Updated

December 4, 2025

Status Verified

November 1, 2025

Enrollment Period

6.2 years

First QC Date

June 27, 2019

Last Update Submit

November 27, 2025

Conditions

Right Colectomy

Keywords

right colectomycalcificationanastomotic leakage

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Calcification score of each segment associated with the occurrence of anastomotic leakage

    6 weeks after surgery

  • Morbidities defined according to Clavien-Dindo classification

    6 weeks after surgery

Study Arms (1)

Right colectomy

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

CHU Angers

Angers, France

Location

Hopital privé de Sévigné

Cesson-Sévigné, France

Location

CH de Challans

Challans, 85300, France

Location

CH de Cholet 1 rue Marengo

Cholet, 49300, France

Location

Centre Hospitalier de Fougères

Fougères, 35300, France

Location

CHD Vendée

La Roche-sur-Yon, 85925, France

Location

Centre Hospitalier du Mans

Le Mans, France

Location

Clinique Mutualiste de la Porte de l'Orient

Lorient, 56324, France

Location

CHU de Nantes

Nantes, 44093, France

Location

Centre Hospitalier de Saint Brieuc

Saint-Brieuc, France

Location

Clinique Mutualiste de l'Estuaire

Saint-Nazaire, 44600, France

Location

Centre Hospitalier Bretagne Atlantique

Vannes, 56017, France

Location

MeSH Terms

Conditions

CalcinosisAnastomotic Leak

Condition Hierarchy (Ancestors)

Calcium Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Emeric ABET

    CHD Vendée

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2019

First Posted

July 1, 2019

Study Start

September 24, 2019

Primary Completion

November 18, 2025

Study Completion

November 18, 2025

Last Updated

December 4, 2025

Record last verified: 2025-11

Locations

FR(12)