Cancer, Rectum, Cancer, Sigmoid
Conditions
Brief 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.
Interventions
proximal occlusion of the inferior mesenteric artery, before its divisional branches, by coils or plug 3-4 weeks prior to surgery.
PROCEDUREInferior mesenteric artery ligation
Endovascular ligation of Inferior mesenteric artery
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oxygen saturation of the colon after inferior mesenteric artery ligation between groups | Prior to start of surgery | Digital oxymeter (%) |
| Arterial pressure after inferior mesenteric artery ligation between groups | Prior to start of surgery | Average (mmHg) |
| Colonic perfusion in the marginal artery after inferior mesenteric artery ligation between groups | Prior to start of surgery | Rectal resistance index measured by Doppler |
| Arterial pressure in the marginal artery after inferior mesenteric artery ligation between groups | 60 seconds after surgery | Average (mmHg) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Presence of post-embolization complications | Day 5 post-emoblization | Yes/No |
| Presence of post-surgery complications | Hospital discharge (Day 7 after surgery) | Yes/No |
Countries
France
Outcome results
None listed