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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04002921
Recruitment Status : Not yet recruiting
First Posted : July 1, 2019
Last Update Posted : July 5, 2019
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease
Right Colectomy

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Study Type : Observational
Estimated Enrollment : 1100 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Evaluation of an Arterial Calcification Score as a Predictive Factor of Anastomotic Leakage in Right Colectomy
Estimated Study Start Date : July 17, 2019
Estimated Primary Completion Date : September 3, 2022
Estimated Study Completion Date : September 3, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Minerals

Group/Cohort
Right colectomy
Patient with scheduled right colectomy and with a documented preoperative scan.



Primary Outcome Measures :
  1. 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:

    • 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 :
  1. Calcification score of each segment associated with the occurrence of anastomotic leakage [ Time Frame: 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.

  2. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patient admitted for right colectomy in one of the 6 hospitals or clinics.
Criteria

Inclusion Criteria:

  • Age ≥ 18 years old
  • Scheduled right colectomy with restoration of digestive continuity and who have had 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04002921


Contacts
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Contact: Stéphanie MARTIN 02 51 44 64 83 stephanie.martin@chd-vendee.fr

Locations
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France
CH de Challans
Challans, France, 85300
Contact: Marion CHARVIN, PH         
Centre Hospitalier Departemental Vendée
La Roche sur Yon, France, 85925
Contact: Stéphanie MARTIN    02 51 44 64 83    stephanie.martin@chd-vendee.fr   
Principal Investigator: Emeric ABET, PH         
Clinique Mutualiste de la Porte de l'Orient
Lorient, France, 56324
Contact: Guillaume LEROUX, PH         
CHU de Nantes
Nantes, France, 44093
Contact: Emilie DUCHALAIS, PH         
Clinique Mutualiste de l'Estuaire
Saint-Nazaire, France, 44600
Contact: Florent JURCZAK, PH         
Centre Hospitalier Bretagne Atlantique
Vannes, France, 56017
Contact: Thimothée THIEBOT, PH         
Sponsors and Collaborators
Centre Hospitalier Departemental Vendee
Investigators
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Study Director: Emeric ABET CHD Vendée
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Responsible Party: Centre Hospitalier Departemental Vendee
ClinicalTrials.gov Identifier: NCT04002921    
Other Study ID Numbers: CHD 086-19
First Posted: July 1, 2019    Key Record Dates
Last Update Posted: July 5, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Departemental Vendee:
right colectomy
calcification
anastomotic leakage
Additional relevant MeSH terms:
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Calcinosis
Anastomotic Leak
Calcium Metabolism Disorders
Metabolic Diseases
Postoperative Complications
Pathologic Processes