Evaluation of an Arterial Calcification Score as a Predictive Factor of Anastomotic Leakage in Right Colectomy
- Conditions
- Right Colectomy
- Registration Number
- NCT04002921
- Lead Sponsor
- Centre Hospitalier Departemental Vendee
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1100
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Total calcification score associated with the occurrence of anastomotic leakage 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 Outcome Measures
Name Time Method Morbidities defined according to Clavien-Dindo classification 6 weeks after surgery Morbidities defined according to Clavien-Dindo classification occurring at 6 weeks postoperatively
Calcification score of each segment associated with the occurrence of anastomotic leakage 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.
Trial Locations
- Locations (16)
Hopital privé de Sévigné
🇫🇷Cesson-Sévigné, France
CHU Angers
🇫🇷Angers, France
Centre Hospitalier de Fougères
🇫🇷Fougères, France
CH de Cholet 1 rue Marengo
🇫🇷Cholet, France
CH de Challans
🇫🇷Challans, France
CHD Vendée
🇫🇷La Roche sur Yon, France
Centre Hospitalier de la Rochelle
🇫🇷La Rochelle, France
Centre Hospitalier du Mans
🇫🇷Le Mans, France
Hopital privé des Cotes d'Armor
🇫🇷Plérin, France
Clinique Mutualiste de la Porte de l'Orient
🇫🇷Lorient, France
CHU de Nantes
🇫🇷Nantes, France
Clinique La Sagesse
🇫🇷Rennes, France
Centre Hospitalier de Saint Brieuc
🇫🇷Saint-Brieuc, France
Clinique Mutualiste de l'Estuaire
🇫🇷Saint-Nazaire, France
Hôpital privé Océane
🇫🇷Vannes, France
Centre Hospitalier Bretagne Atlantique
🇫🇷Vannes, France