Damage Control Surgery in Acute Mesenteric Ischemia

Gao Tao

Status: Unknown

Conditions: Damage Control

Treatments: Procedure: non-damage control surgery; Procedure: damage control surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT03966430

2014NZGKJ-020

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

damage control surgery group

Experimental group

Description:

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.

Treatment:

Procedure: damage control surgery

non-damage control surgery group

Sham Comparator group

Description:

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.

Treatment:

Procedure: non-damage control surgery