Clinical trial NCT04002921: Evaluation of an Arterial Calcification Score as a Predictive Factor of Anastomotic Leakage in Right Colectomy
Official title: Evaluation of an Arterial Calcification Score as a Predictive Factor of Anastomotic Leakage in Right Colectomy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Right Colectomy
Keywords: right colectomy
calcification
anastomotic leakage
Lead sponsor: Centre Hospitalier Departemental Vendee
Sponsor class: OTHER
First posted: 2019-07-01
Enrollment: 1100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient admitted for right colectomy in one of the 6 hospitals or clinics.

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.


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

Primary outcomes:
measure: Total calcification score associated with the occurrence of anastomotic leakage
timeFrame: 6 weeks after surgery
Secondary outcomes:
measure: Calcification score of each segment associated with the occurrence of anastomotic leakage
timeFrame: 6 weeks after surgery
measure: Morbidities defined according to Clavien-Dindo classification
timeFrame: 6 weeks after surgery
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
city: Cesson-Sévigné
country: France
facility: Hopital privé de Sévigné
city: Challans
country: France
facility: CH de Challans
city: Cholet
country: France
facility: CH de Cholet 1 rue Marengo
city: Fougères
country: France
facility: Centre Hospitalier de Fougères
city: La Roche sur Yon
country: France
facility: CHD Vendée
city: La Rochelle
country: France
facility: Centre Hospitalier de la Rochelle
city: Le Mans
country: France
facility: Centre Hospitalier du Mans
city: Lorient
country: France
facility: Clinique Mutualiste de la Porte de l'Orient
city: Nantes
country: France
facility: CHU de Nantes
city: Plérin
country: France
facility: Hopital privé des Cotes d'Armor
city: Rennes
country: France
facility: Clinique La Sagesse
city: Saint-Brieuc
country: France
facility: Centre Hospitalier de Saint Brieuc
city: Saint-Nazaire
country: France
facility: Clinique Mutualiste de l'Estuaire
city: Vannes
country: France
facility: Centre Hospitalier Bretagne Atlantique
city: Vannes
country: France
facility: Hôpital privé Océane
Study officials:
affiliation: CHD Vendée
name: Emeric ABET
role: PRINCIPAL_INVESTIGATOR
References: