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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Cancer, Sigmoid, Cancer, Rectum

Intervention / Treatment
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* Procedure: embolization of the inferior mesenteric artery
* Procedure: Inferior mesenteric artery ligation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: embolization<br> | Procedure: embolization of the inferior mesenteric artery<br>* proximal occlusion of the inferior mesenteric artery, before its divisional branches, by coils or plug 3-4 weeks prior to surgery.<br>Procedure: Inferior mesenteric artery ligation<br>* Endovascular ligation of Inferior mesenteric artery<br>|
| Other: No embolization<br> | Procedure: Inferior mesenteric artery ligation<br>* Endovascular ligation of Inferior mesenteric artery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygen saturation of the colon after inferior mesenteric artery ligation between groups | Digital oxymeter (%) | Prior to start of surgery | 
| Arterial pressure after inferior mesenteric artery ligation between groups | Average (mmHg) | Prior to start of surgery | 
| Colonic perfusion in the marginal artery after inferior mesenteric artery ligation between groups | Rectal resistance index measured by Doppler | Prior to start of surgery | 
| Oxygen saturation of the colon after inferior mesenteric artery ligation between groups | Digital oxymeter (%) | 60 seconds after surgery | 
| Oxygen saturation of the colon after inferior mesenteric artery ligation between groups | Digital oxymeter (%) | 5 minutes after surgery | 
| Arterial pressure in the marginal artery after inferior mesenteric artery ligation between groups | Average (mmHg) | 60 seconds after surgery | 
| Arterial pressure in the marginal artery after inferior mesenteric artery ligation between groups | Average (mmHg) | 5 minutes after surgery | 
| Colonic perfusion in the marginal artery after inferior mesenteric artery ligation between groups | Rectal resistance index measured by Doppler | 60 seconds after surgery | 
| Colonic perfusion in the marginal artery after inferior mesenteric artery ligation between groups | Rectal resistance index measured by Doppler | 5 minutes after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of post-embolization complications | Yes/No | Day 5 post-emoblization | 
| Presence of post-surgery complications | Yes/No | Hospital discharge (Day 7 after surgery) |