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临床试验/NCT04686981
NCT04686981已完成不适用

Vascular Surgery Department of Beijing Tsinghua Chang Gung Hospital

Beijing Tsinghua Chang Gung Hospital1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2020年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
42
试验地点
1
主要终点
survival rate with preserved bowel function

研究概览

简要总结

Acute mesenteric artery thromboembolism(AMT) is one of the important causes of acute abdomen and intestinal necrosis. If the intestinal blood supply is not restore in time, the prognosis of the disease is often poor and even endangers the life of the patient. Through laparoscopic surgery combined with modern minimally invasive endovascular technology, the blood supply of patients' intestine is restored. Observe the perioperative vascular patency rate, all-cause mortality, and the probability of short bowel syndrome. Through the hybrid operating room, we want to seek a multidisciplinary collaborative treatment mode to improve the long-term survival rate of such patients with enough intestines and completely free from TPN, and improve the prognosis of these patients.

详细描述

This study is a clinical cohort study; consecutively registered 30 patients with acute intestinal ischemia caused by superior mesenteric artery thromboembolism.

If all the radiography, physical signs, and laboratory markers hint at intestinal necrosis, exploratory laparotomy followed by enterectomy and thrombectomy is the first choice. If none of them hint at intestinal necrosis, endovascular therapy is superior. Laparoscopic exploration followed by endovascular therapy was performed for other patients, after that the intestinal blood supply was evaluated again by laparoscopy.

The main endpoints are the survival rate of bowel function preserved at 30 days, and the secondary endpoints are 30-day mortality, in-hospital mortality, symptoms-free survival rate, and rate of transition to laparotomy.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with intestinal ischemia and acute abdomen pain caused by superior mesenteric artery thromboembolism

排除标准

  • Those who have acute large-area myocardial infarction, large-area cerebral infarction, or have serious heart failure or sequelae of cerebral infarction within 1 month;
  • Combined with portal hypertension, gastrointestinal hemorrhage, portal and mesenteric venous reflux obstruction diseases;
  • Contrast agent allergy, severe renal insufficiency, and inability to perform intravascular surgery;
  • Past medical history contains superior mesenteric artery thromboembolism.
  • Patients diagnosed with intestinal necrosis and peritonitis before surgery based on physical signs and imaging studies who directly undergo laparotomy and incision for thrombectomy.
  • Patients without intestinal necrosis or peritonitis based on physical signs and imaging studies, who are treated by endovascular intervention therapy directly.

结局指标

主要结局

survival rate with preserved bowel function

时间窗: within 30 days after operations

Counting data

次要结局

  • the incidence of all-cause mortality(within 30 days after operations)
  • vascular patency rate(180 days after operations)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Weiwei Wu

Department director

Beijing Tsinghua Chang Gung Hospital

研究点 (1)

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