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 December 21, 2024

Recruiting

Keywords

Ischemic Preconditioning Surgery Cancer, Rectal Inferior Mesenteric Artery Embolus

ClinConnect Summary

This clinical trial is studying a procedure called inferior mesenteric artery embolization, which is done before surgery for patients with tumors in the lower or middle part of the rectum. The goal is to find out if this procedure is safe and to see if it can help reduce complications after surgery, such as the formation of fistulas (abnormal connections between organs). Researchers believe that this method may improve blood flow to the colon after three weeks, leading to better healing and fewer issues during recovery.

To participate in the trial, patients must have rectal cancer that requires surgery and be able to provide informed consent. They should not have had previous abdominal surgeries or certain health conditions that could complicate the procedure. Participants will be closely monitored throughout the trial to ensure their safety and to gather important information about the effects of the treatment. Overall, this study aims to improve surgical outcomes for patients undergoing treatment for rectal cancer.

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 Centre Hospitalier Universitaire De Nīmes

The Centre Hospitalier Universitaire de Nîmes (CHU Nîmes) is a leading academic medical center located in Nîmes, France, dedicated to advancing healthcare through innovative clinical research and patient care. As a prominent sponsor of clinical trials, CHU Nîmes collaborates with a multidisciplinary team of healthcare professionals and researchers to conduct rigorous studies aimed at improving treatment outcomes and enhancing medical knowledge across various specialties. With a strong commitment to ethical standards and patient safety, CHU Nîmes fosters a research environment that encourages scientific excellence and contributes to the development of new therapies and healthcare solutions.

Locations

Montpellier, , France

Montpellier, , France

Nîmes, , France

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0