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

Not Applicable

Completed

• Conditions: Cancer, Rectum; Cancer, Sigmoid
• Interventions: Procedure: Inferior mesenteric artery ligation; Procedure: embolization of the inferior mesenteric artery

• Registration Number: NCT03628248
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-09
• Study First Submitted QC: 2018-08-09
• Study First Posted: 2018-08-14
• Study Start: 2020-03-10
• Primary Completion: 2021-06-24
• Study Completion: 2021-06-24
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-03
• Last Update Posted: 2021-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No embolization	Inferior mesenteric artery ligation	-
embolization	embolization of the inferior mesenteric artery	-
embolization	Inferior mesenteric artery ligation	-

Primary Outcome Measures

Name	Time	Method
Colonic perfusion in the marginal artery after inferior mesenteric artery ligation between groups	5 minutes after surgery	Rectal resistance index measured by Doppler
Arterial pressure in the marginal artery after inferior mesenteric artery ligation between groups	5 minutes after surgery	Average (mmHg)
Arterial pressure after inferior mesenteric artery ligation between groups	Prior to start of surgery	Average (mmHg)
Oxygen saturation of the colon after inferior mesenteric artery ligation between groups	5 minutes after surgery	Digital oxymeter (%)

Secondary Outcome Measures

Name	Time	Method
Presence of post-embolization complications	Day 5 post-emoblization	Yes/No
Presence of post-surgery complications	Hospital discharge (Day 7 after surgery)	Yes/No

Trial Locations

Locations (1)

CHU Nimes; 🇫🇷 Nimes, France