Evaluating arterial calcification to predict complications after right colectomy

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

This study is testing if a score based on artery calcification from CT scans can help predict the risk of complications after surgery for people having their right colon removed.

Quick facts

• Study type: Observational
• Enrollment: 1100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Centre Hospitalier Departemental Vendee (other)
• Locations: 16 sites (Angers and 15 other locations)
• Trial ID: NCT04002921 on ClinicalTrials.gov

What this trial studies

This observational study aims to validate a calcification score derived from preoperative CT scans of the coeliac trunk and mesenteric arteries to predict the risk of anastomotic leakage in patients undergoing right colectomy. The study builds on previous findings that indicated a calcification score of 3 or higher is associated with increased risk of postoperative complications. By analyzing data from multiple centers, the study seeks to enhance preoperative assessments and improve patient outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older scheduled for right colectomy with a preoperative abdominal-pelvic CT scan.

Not a fit: Patients with chronic inflammatory bowel disease requiring surgery, those with a history of colic resection, or individuals under guardianship will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could help identify patients at higher risk for anastomotic leakage, allowing for better preoperative planning and management.

How similar studies have performed: Previous studies have indicated a correlation between calcification scores and postoperative complications, suggesting this approach has potential based on earlier findings.

Eligibility criteria

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

Where this trial is running

Angers and 15 other locations

• CHU Angers — Angers, France (RECRUITING)
• Hopital privé de Sévigné — Cesson-Sévigné, France (RECRUITING)
• CH de Challans — Challans, France (RECRUITING)
• CH de Cholet 1 rue Marengo — Cholet, France (RECRUITING)
• Centre Hospitalier de Fougères — Fougères, France (RECRUITING)
• CHD Vendée — La Roche sur Yon, France (RECRUITING)
• Centre Hospitalier de la Rochelle — La Rochelle, France (RECRUITING)
• Centre Hospitalier du Mans — Le Mans, France (RECRUITING)
• Clinique Mutualiste de la Porte de l'Orient — Lorient, France (RECRUITING)
• CHU de Nantes — Nantes, France (RECRUITING)
• Hopital privé des Cotes d'Armor — Plérin, France (RECRUITING)
• Clinique La Sagesse — Rennes, France (RECRUITING)
• Centre Hospitalier de Saint Brieuc — Saint-Brieuc, France (RECRUITING)
• Clinique Mutualiste de l'Estuaire — Saint-Nazaire, France (RECRUITING)
• Centre Hospitalier Bretagne Atlantique — Vannes, France (RECRUITING)
• Hôpital privé Océane — Vannes, France (NOT_YET_RECRUITING)

Study contacts

• Principal investigator: Emeric ABET — CHD Vendée
• Study coordinator: Agnes DORION

Conditions: Right Colectomy, right colectomy, calcification, anastomotic leakage