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OpenTrials
Completed

NCT Number: NCT03628248

Effect of Endovascular Inferior Mesenteric Artery Embolization on Colonic Perfusion Prior to Rectal Surgery for Rectal Tumor or Sigmoid Colon Surgery

The investigators hypothesize that a primary embolization, 3-4 weeks before surgery, would allow development of vascular collaterality, in particular for the marginal artery which will ensure a better colonic perfusion.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The patient must have given their free and informed consent and signed the consent form
  • The patient must be a member or beneficiary of a health insurance plan
  • The patient is at least 18 years old and less than 80 years old
  • Patient has rectal cancer or sigmoid colon cancer requiring surgical treatment

Exclusion criteria

  • The subject is participating in another study, or is in a period of exclusion determined by a previous study
  • The subject refuses to sign the consent
  • It is impossible to give the subject informed information
  • The patient is under safeguard of justice or state guardianship
  • Patient has a history of abdominal surgery
  • Patient suffers from a hemostasis disorder (hemophilia, von Willebrand disease, thrombocytopenia) and is on anticoagulant therapy.
  • Patient whose general condition appears too precarious or is taking corticosteroids or immunosuppressants leading to an unacceptable surgical risk.
  • Renal insufficiency with clearance <45ml / min
  • Known allergy to contrast media
  • Patient who had treatment of the abdominal aorta or its branches Reported pregnancy (the existence of effective contraception will be verified for women of childbearing age).
  • Anatomical variant at risk or absence of marginal artery highlighted at the time of arteriography.
  • Abnormality of the superior mesenteric artery
  • Historic occlusion of the inferior mesenteric artery

Treatment and study plan

embolization of the inferior mesenteric artery

Procedure

proximal occlusion of the inferior mesenteric artery, before its divisional branches, by coils or plug 3-4 weeks prior to surgery.

Inferior Mesenteric Artery Ligation

Procedure

Endovascular ligation of Inferior mesenteric artery

Primary outcomes

  1. Oxygen saturation of the colon after inferior mesenteric artery ligation between groups

    Time frame: Prior to start of surgery

    Digital oxymeter (%)

  2. Arterial pressure after inferior mesenteric artery ligation between groups

    Time frame: Prior to start of surgery

    Average (mmHg)

  3. Colonic perfusion in the marginal artery after inferior mesenteric artery ligation between groups

    Time frame: Prior to start of surgery

    Rectal resistance index measured by Doppler

  4. Oxygen saturation of the colon after inferior mesenteric artery ligation between groups

    Time frame: 60 seconds after surgery

    Digital oxymeter (%)

  5. Oxygen saturation of the colon after inferior mesenteric artery ligation between groups

    Time frame: 5 minutes after surgery

    Digital oxymeter (%)

  6. Arterial pressure in the marginal artery after inferior mesenteric artery ligation between groups

    Time frame: 60 seconds after surgery

    Average (mmHg)

  7. Arterial pressure in the marginal artery after inferior mesenteric artery ligation between groups

    Time frame: 5 minutes after surgery

    Average (mmHg)

  8. Colonic perfusion in the marginal artery after inferior mesenteric artery ligation between groups

    Time frame: 60 seconds after surgery

    Rectal resistance index measured by Doppler

  9. Colonic perfusion in the marginal artery after inferior mesenteric artery ligation between groups

    Time frame: 5 minutes after surgery

    Rectal resistance index measured by Doppler

Secondary outcomes

  1. Presence of post-embolization complications

    Time frame: Day 5 post-emoblization

    Yes/No

  2. Presence of post-surgery complications

    Time frame: Hospital discharge (Day 7 after surgery)

    Yes/No

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

Effect of Endovascular Inferior Mesenteric Artery Embolization on Colonic Perfusion Prior to Rectal Surgery for Rectal Tumor or Sigmoid Colon Surgery - A Single-center Feasibility Pilot Study.

Acronym: AMIREMBOL

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 14, 2018
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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