NCT03628248已完成不适用
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.
Centre Hospitalier Universitaire de Nīmes2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2020年3月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Colonic perfusion in the marginal artery after inferior mesenteric artery ligation between groups
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Colonic perfusion in the marginal artery after inferior mesenteric artery ligation between groups
时间窗: 5 minutes after surgery
Rectal resistance index measured by Doppler
Arterial pressure in the marginal artery after inferior mesenteric artery ligation between groups
时间窗: 5 minutes after surgery
Average (mmHg)
Arterial pressure after inferior mesenteric artery ligation between groups
时间窗: Prior to start of surgery
Average (mmHg)
Oxygen saturation of the colon after inferior mesenteric artery ligation between groups
时间窗: 5 minutes after surgery
Digital oxymeter (%)
次要结局
- Presence of post-embolization complications(Day 5 post-emoblization)
- Presence of post-surgery complications(Hospital discharge (Day 7 after surgery))
研究者
研究点 (2)
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