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

Right Colectomy Clinical Trial

— RIGHTCOLOCALCI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04002921
• Other study ID #: CHD 086-19
• Status: Recruiting
• Start date: September 24, 2019
• Est. completion date: November 10, 2025

Study information

• Verified date: July 2023
• Source: Centre Hospitalier Departemental Vendee
• Contact: Agnes DORION
• Phone: 0251446380
• Email: agnes.dorion[@]ght85.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1100
• Est. completion date: November 10, 2025
• Est. primary completion date: November 10, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anastomotic Leak
• Calcinosis
• Right Colectomy

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Departemental Vendee

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	6 weeks after surgery
Secondary	Morbidities defined according to Clavien-Dindo classification	Morbidities defined according to Clavien-Dindo classification occurring at 6 weeks postoperatively	6 weeks after surgery