Search / Trial NCT06236633

Safety & Efficacy of Ischemic Preconditioning by Embolization of the Inferior Mesenteric Artery in Surgery for Tumors of Lower and Middle Rectum

Launched by CENTRE HOSPITALIER UNIVERSITAIRE DE NĪMES · Jan 31, 2024

Trial Information

Current as of October 03, 2024

Recruiting

Keywords

Ischemic Preconditioning Surgery Cancer, Rectal Inferior Mesenteric Artery Embolus

Description

Anastomotic fistulas are the main cause of morbidity and mortality in colorectal surgery. They are responsible for septic complications, leading to increased mortality, local recurrence, repeat surgery and impaired sexual, urinary and digestive function. Fistulas are multifactorial; among the causes, colonic vascularization seems to be a major one. Ligation of the inferior mesenteric artery during rectal surgery has been shown to reduce intraoperative colonic perfusion flow. The left colon is then vascularized only by the colonic border arcade, perfused by the superior mesenteric artery. Is...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • * Patients with cancer of the lower or middle rectum, eligible for surgical treatment requiring ligation at the origin of the inferior mesenteric artery.
  • * Patients with free, informed consent.
  • * Patients affiliated to or benefiting from a health insurance plan.
  • Exclusion Criteria:
  • * Patients with history of abdominal surgery.
  • * Patients with occlusion of the superior mesenteric artery or stenosis of more than 50%, visible on the CT scan performed as part of conventional management during extension workup.
  • * Patients with occlusion of the IMA on the extension scan.
  • * Patients with a systemic disorder responsible for haemostasis (haemophilia, Willebrand's disease, thrombocytopenia) and on anticoagulant therapy.
  • * Patients taking corticosteroids or immunosuppressants leading to an unacceptable surgical risk.
  • * Patients with renal insufficiency with clearance \< 30mL/min.
  • * Patients with an allergy to iodine.
  • * Patients who has had treatment of the abdominal aorta or its branches.
  • * Patients participating in an interventional study.
  • * Patients in an exclusion period determined by another study.
  • * Patients under court protection, guardianship or curatorship.
  • * Patients unable to give consent.
  • * Patients for whom it is impossible to provide informed information.
  • * Pregnant or breast-feeding patients.

About Sponsor

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Montpellier, , France

Montpellier, , France

Nîmes, , France

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0