Effect of Endovascular Inferior Mesenteric Artery Embolization on Colonic Perfusion Prior to Rect… (NCT03628248) | Clinical Trial Compass
CompletedNot Applicable
Effect of Endovascular Inferior Mesenteric Artery Embolization on Colonic Perfusion Prior to Rectal Surgery for Rectal Tumor or Sigmoid Colon Surgery
France10 participantsStarted 2020-03-10
Plain-language summary
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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Oxygen saturation of the colon after inferior mesenteric artery ligation between groups
Timeframe: Prior to start of surgery
2
Arterial pressure after inferior mesenteric artery ligation between groups
Timeframe: Prior to start of surgery
3
Colonic perfusion in the marginal artery after inferior mesenteric artery ligation between groups
Timeframe: Prior to start of surgery
4
Oxygen saturation of the colon after inferior mesenteric artery ligation between groups
Timeframe: 60 seconds after surgery
5
Oxygen saturation of the colon after inferior mesenteric artery ligation between groups
Timeframe: 5 minutes after surgery
6
Arterial pressure in the marginal artery after inferior mesenteric artery ligation between groups
Timeframe: 60 seconds after surgery
7
Arterial pressure in the marginal artery after inferior mesenteric artery ligation between groups