跳至主要内容
临床试验/NCT03966430
NCT03966430Unknown不适用

Jinling Hospital, Medical School of Nanjing University

Gao Tao1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2014年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
1
主要终点
Rate of postoperative abdominal sepsis

研究概览

简要总结

Acute mesenteric ischemia (AMI) is a rare but catastrophic abdominal vascular emergency associated with daunting mortality comparable to myocardial infarction or cerebral stroke. Damage control surgery has been extensively used in severe traumatic patients. Very urgent, there was no large-scale in-depth study when extended to a nontrauma setting, especially in the intestinal stroke center. Recently, the liberal use of OA as a damage control surgery adjunct has been proved to improve the clinical outcome in acute superior mesenteric artery occlusion patients. However, there was little information when extended to a prospective study. The purpose of this prospective cohort study was to evaluate whether the application of damage control surgery concept in AMI was related to avoiding postoperative abdominal infection, reduced secondary laparotomy, reduced mortality and improved the clinical outcomes in short bowel syndrome.

详细描述

Acute mesenteric ischemia (AMI) is a rare but catastrophic abdominal vascular emergency associated with daunting mortality comparable to myocardial infarction or cerebral stroke. Computed tomographic angiography is the initial diagnostic examination of choice for patients in whom AMI is a consideration. Computed tomographic angiography can be performed rapidly and can be used to identify critical arterial stenosis or occlusion as well as providing information concerning the presence of bowel infarction. An uncommon cause of presentation to emergency rooms, lack of clinical suspicion often leads to delayed presentation, development of peritoneal signs, and subsequent staggeringly high mortality rates.

Now in use for over 2 decades, the concept of damage control surgery (DCS) has become an accepted, proven surgical strategy with wide applicability and success in severe trauma patients. The concept has been mostly used in the massively injured, exsanguinating patients with multiple competing surgical priorities. With growing experiences in the application, the strategy continues to evolve into a nontrauma setting, especially in AMI.

Although an increasing development of endovascular techniques, AMI remains a morbid condition with a poor short-term and long-term survival rate. Some authors advocated that laparotomy after mesenteric revascularization serves to evaluate the possible damage to the visceral organs. Bowel resection as a result of transmural necrosis is carried out according to the principles of DCS. Bowel resections are performed with staples, leaving the creation of stomas until the second-look laparotomy. The abdominal wall can be left unsutured and temporary abdominal closure (TAC) was applied. However, the use of DCS in the setting of AMI was limited in case series and mostly confined in large university teaching hospitals. The timing and details of how the DCS incorporated into the treatment algorithm of AMI deserved further investigations.

An integrated intestinal stroke center (ISC) was established in our department, a national cutting-edge referral center for intestinal failure, to build up ideal coordination among gastroenterology physician, gastrointestinal and vascular surgeon, and intervention radiologist for this therapeutic challenge. DCS was liberally used since ISC was established in 2010.

In this prospective cohort study, we aimed to compare the clinical outcomes of patients receiving DCS and non-DCS in the devastating conditions in our single center.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects and their families voluntarily and sign the informed consent form for this trial;
  • Age is greater than or equal to 18 years old, less than or equal to 75 years old;
  • Patients diagnosed with AMI;
  • Subjects can objectively describe the symptoms and follow the follow-up plan.

排除标准

  • Those who are judged by the physician to be unfit to participate in the test;
  • non-obstructive mesenteric ischemia;
  • Aortic dissection complicated with visceral ischemia;
  • Intestinal ischemia secondary to other causes (such as volvulus, intestinal adhesion, strangulation);
  • There is irreversible heart failure, liver failure or renal failure before diagnosis;
  • History of intestinal ischemia surgery or complex abdominal surgery;
  • Patients who are unable to perform surgical treatment for injury control or have surgical contraindications for significant injury control;
  • Pregnancy, lactating women, subjects with a pregnancy plan within 1 month after the test (including male subjects);
  • Participate in other clinical trials within 3 months before the trial;
  • Transfer to the hospital within 1 week or discharge automatically;
  • Sponsors or researchers or their family members who are directly involved in the trial.

研究组 & 干预措施

damage control surgery group

Experimental

According to the discussion between the patient and the doctor, the patient signed the consent form and voluntarily enrolled and subsequently the patient was included in the damage control surgery group.

干预措施: damage control surgery (Procedure)

non-damage control surgery group

Sham Comparator

According to the discussion between the patient and the doctor, the patient signed the consent form and voluntarily enrolled and subsequently the patient was included in the non-damage control surgery group.

干预措施: non-damage control surgery (Procedure)

结局指标

主要结局

Rate of postoperative abdominal sepsis

时间窗: 30 days

All cause postoperative abdominal infection

Postoperative short bowel syndrome rate

时间窗: 30 days

All cause postoperative short bowel syndrome

Postoperative 30-day mortality

时间窗: 30 days

All cause mortality within 30 days

Rate of postoperative re-laparotomy

时间窗: 30 days

All cause postoperative re-laparotomy

次要结局

  • Recovery of intestinal function(30 days)
  • Postoperative activity time(30 days)
  • Coagulation markers(Postoperative day-1, 3, 5, 7)
  • Rate of abdominal septic complications(30 days)
  • Rate of non-abdominal septic complications(30 days)
  • Infectious markers(Postoperative day-1, 3, 5, 7)
  • Rate of abdominal non-septic complications(30 days)
  • Rate of systematic complications(30 days)
  • Length of preoperative stay(30 days)
  • Operative information(30 days)
  • General nutritional information measurement(Postoperative day-1, 3, 5, 7)
  • Immunological markers(Preoperative day-1 and postoperative day-1, 3, 5, 7)
  • Hospital costs(1 year)
  • Intraoperative intestinal length(30 days)
  • Re-admission rate 30 days after discharge(30 days)
  • Postoperative hospital stay(1 year)
  • Type of intestinal anastomosis(30 days)
  • The amount of nutritional support treatment(30 days)
  • Catheter condition(30 days)
  • Inflammatory markers(Postoperative day-1, 3, 5, 7)
  • Amount of fluid input and output during operation(30 days)
  • Degree of postoperative activity(30 days)
  • Serum nutrition marker(Postoperative day-1, 3, 5, 7)
  • Fibrinolytic markers(Postoperative day-1, 3, 5, 7)
  • Type of abdominal drainage(30 days)
  • The composition of nutritional support treatment(30 days)
  • Intestinal barrier function markers(Postoperative day-1, 3, 5, 7)
  • Postoperative ICU stay(1 year)
  • Operation time(30 days)
  • Embolus size measurement(30 days)
  • The time of nutritional support treatment(30 days)
  • Type of abdominal closure(30 days)
  • Marker of neutrophil extracellular traps markers(Preoperative day-1 and postoperative day-1, 3, 5, 7)

研究者

发起方
Gao Tao
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Gao Tao

Clinical Professor

Nanjing PLA General Hospital

研究点 (1)

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