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OpenTrials
Completed

NCT Number: NCT04002921

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Angers, Angers, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.
  2. 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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Departemental Vendee

Other

Registry information

Acronym: RIGHTCOLOCALCI

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Jul 1, 2019
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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