- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04002921
Evaluation of an Arterial Calcification Score as a Predictive Factor of Anastomotic Leakage in Right Colectomy (RIGHTCOLOCALCI)
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Agnes DORION
- Phone Number: 0251446380
- Email: agnes.dorion@ght85.fr
Study Locations
-
-
-
Angers, France
- Recruiting
- CHU Angers
-
Principal Investigator:
- Stéphanie MUSSI, PH
-
Cesson-Sévigné, France
- Recruiting
- Hopital privé de Sévigné
-
Principal Investigator:
- Christine TISSON, PH
-
Challans, France, 85300
- Recruiting
- CH de Challans
-
Principal Investigator:
- Marion CHARVIN, PH
-
Cholet, France, 49300
- Recruiting
- CH de Cholet 1 rue Marengo
-
Principal Investigator:
- François RADE, PH
-
Fougères, France, 35300
- Recruiting
- Centre Hospitalier de Fougères
-
Principal Investigator:
- Emmanuel NAUDEIX, PH
-
La Roche sur Yon, France, 85925
- Recruiting
- CHD Vendee
-
Principal Investigator:
- Emeric ABET, PH
-
La Rochelle, France
- Recruiting
- Centre Hospitalier de La Rochelle
-
Principal Investigator:
- Pierre-Yves LEFANT, PH
-
Le Mans, France
- Recruiting
- Centre Hospitalier du Mans
-
Principal Investigator:
- Julien BARBIEUX, PH
-
Lorient, France, 56324
- Recruiting
- Clinique Mutualiste de la Porte de l'Orient
-
Principal Investigator:
- Guillaume LEROUX, PH
-
Nantes, France, 44093
- Recruiting
- CHU de Nantes
-
Principal Investigator:
- Emilie DUCHALAIS, PH
-
Plérin, France
- Recruiting
- Hopital Privé des Cotes d'Armor
-
Principal Investigator:
- Corentin DUFAY, PH
-
Rennes, France
- Recruiting
- Clinique La Sagesse
-
Principal Investigator:
- Philippe METZLER, PH
-
Saint-Brieuc, France
- Recruiting
- Centre Hospitalier de Saint Brieuc
-
Principal Investigator:
- Laetitia COURTIN TANGUY, PH
-
Saint-Nazaire, France, 44600
- Recruiting
- Clinique Mutualiste de l'Estuaire
-
Principal Investigator:
- Florent JURCZAK, PH
-
Vannes, France, 56017
- Recruiting
- Centre Hospitalier Bretagne Atlantique
-
Principal Investigator:
- Thimothée THIEBOT, PH
-
Vannes, France
- Not yet recruiting
- Hôpital Privé Océane
-
Principal Investigator:
- Guillaume BOULANGER, PH
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Right colectomy
Patient with scheduled right colectomy and with a documented preoperative scan.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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:
|
6 weeks after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Calcification score of each segment associated with the occurrence of anastomotic leakage
Time Frame: 6 weeks after surgery
|
4 segments:
|
6 weeks after surgery
|
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
|
6 weeks after surgery
|
Collaborators and Investigators
Investigators
- Principal Investigator: Emeric ABET, CHD Vendee
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHD 086-19
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Right Colectomy
-
Federico II UniversityCompleted
-
Distalmotion SARecruitingHysterectomy | Partial Nephrectomy | Right ColectomySwitzerland, France, Germany
-
M.S.T. Medical Surgery Technology LTD.CompletedPatients Scheduled for Hernia Repair, Cholecystectomy, Right Colectomy, Nissen Fundoplication and Sigmoid ResectionIsrael, Netherlands, Italy
-
Haukeland University HospitalIntuitive SurgicalRecruitingRight Colectomy | Lymphadenectomy | Right Sided Colon CancerNorway
-
University Hospital, LimogesTerminatedExtended Ileal Resection Under Laparotomy | Total Proctocolectomy Under Laparotomy | Colectomy Left/Right/Total Under Laparotomy | Rectosigmoidal Resection Under Laparotomy | Anterior Resection of Rectum Under Laparotomy | Abdomino-perineal Amputation Under LaparotomyFrance
-
Mansoura UniversityNot yet recruitingLaparoscopic ColectomyEgypt
-
Duke UniversityPacira Pharmaceuticals, IncCompleted
-
University of Lausanne HospitalsCompletedLaparoscopic ColectomySwitzerland
-
Ethicon Endo-SurgeryCompletedColectomy; Gynecological; ThoracicUnited States, United Kingdom
-
University of MinnesotaColon and Rectal Surgery Associates, Ltd.CompletedColorectal Surgery | Colectomy | IleostomyUnited States