ClinicalTrials.gg
CompletedNCT04002921RIGHTCOLOCALCIUpdated Dec 4, 2025

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

An observational study in Right Colectomy, sponsored by Centre Hospitalier Departemental Vendee. Completed at 12 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-04.

Sponsored by Centre Hospitalier Departemental Vendee · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
615
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Right Colectomy

Keywords

  • right colectomy
  • calcification
  • anastomotic leakage
03

In context

Calcinosis

91 studies on the registry are indexed under Calcinosis; 19 are open to participants now.

This study's enrollment of 615 is above the median of 180 across 31 observational studies indexed under Calcinosis.

Browse Calcinosis studies →

Lead sponsor

Centre Hospitalier Departemental Vendee is the lead sponsor of 83 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Patient requiring a right colectomy or ileocaecal resection for chronic inflammatory bowel disease or on long-term therapy
  • Patient with a history of colic resection
  • Patient under guardianship, curatorship, or deprived of liberty
  • Pregnant, postpartum or breastfeeding women
  • Minor patients
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
615 participants (actual)
Patient registry
No

Groups and cohorts

  • Right colectomy

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

06

What researchers measure

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

    Time frame: 6 weeks after surgery

Secondary outcomes

  1. 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.

    Time frame: 6 weeks after surgery

  2. Morbidities defined according to Clavien-Dindo classification

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

    Time frame: 6 weeks after surgery

07

Study locations

12 sites
  • CHU Angers
    Angers, France
  • Hopital privé de Sévigné
    Cesson-Sévigné, France
  • CH de Challans
    Challans, 85300, France
  • CH de Cholet 1 rue Marengo
    Cholet, 49300, France
  • Centre Hospitalier de Fougères
    Fougères, 35300, France
  • CHD Vendée
    La Roche-sur-Yon, 85925, France
  • Centre Hospitalier du Mans
    Le Mans, France
  • Clinique Mutualiste de la Porte de l'Orient
    Lorient, 56324, France
  • CHU de Nantes
    Nantes, 44093, France
  • Centre Hospitalier de Saint Brieuc
    Saint-Brieuc, France
  • Clinique Mutualiste de l'Estuaire
    Saint-Nazaire, 44600, France
  • Centre Hospitalier Bretagne Atlantique
    Vannes, 56017, France
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2019 to primary completion in Nov 2025, 73 months.

Of 14 observational studies under Calcinosis, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 73. This study's 73 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 27, 2019
First posted
Jul 1, 2019
StartActual
Sep 24, 2019
Primary completionActual
Nov 18, 2025
CompletionActual
Nov 18, 2025
Last update
Dec 4, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04002921
Lead sponsor
Centre Hospitalier Departemental Vendee
Responsible party
Sponsor
First posted
Jul 1, 2019
Start date
Sep 24, 2019
Primary completion
Nov 18, 2025
Completion
Nov 18, 2025
Last update
Dec 4, 2025

Study contacts

Emeric ABET
principal investigator · CHD Vendée

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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