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Completed

NCT Number: NCT04686981

Endovascular thromBectomy of Acute Mesentery Vessels Occlusion Hybrid With Emergent Laparoscopic Surgery

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Tsinghua Chang Gung Hosipital

Beijing, Beijing Municipality, 102218, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. survival rate with preserved bowel function

    Time frame: within 30 days after operations

    Counting data

Secondary outcomes

  1. the incidence of all-cause mortality

    Time frame: within 30 days after operations

    Counting data

  2. vascular patency rate

    Time frame: 180 days after operations

    Counting data

Sponsors and collaborators

Lead sponsor

Beijing Tsinghua Chang Gung Hospital

Other

Registry information

Official study title

Vascular Surgery Department of Beijing Tsinghua Chang Gung Hospital

Acronym: BOWEL

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Dec 29, 2020
Registry last updated
Mar 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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