Clinical trial NCT03966430: Damage Control Surgery in Acute Mesenteric Ischemia
Official title: Jinling Hospital, Medical School of Nanjing University
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Damage Control
Keywords: damage control surgery
acute mesenteric ischemia
complication
Lead sponsor: Nanjing PLA General Hospital
Sponsor class: OTHER
First posted: 2019-05-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: a single center prospective cohort study
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Postoperative 30-day mortality
timeFrame: 30 days
measure: Rate of postoperative abdominal sepsis
timeFrame: 30 days
measure: Rate of postoperative re-laparotomy
timeFrame: 30 days
measure: Postoperative short bowel syndrome rate
timeFrame: 30 days
Secondary outcomes:
measure: Rate of abdominal septic complications
timeFrame: 30 days
measure: Rate of non-abdominal septic complications
timeFrame: 30 days
measure: Rate of abdominal non-septic complications
timeFrame: 30 days
measure: Rate of systematic complications
timeFrame: 30 days
measure: Length of preoperative stay
timeFrame: 30 days
measure: Operative information
timeFrame: 30 days
measure: Recovery of intestinal function
timeFrame: 30 days
measure: The amount of nutritional support treatment
timeFrame: 30 days
measure: Catheter condition
timeFrame: 30 days
measure: Postoperative activity time
timeFrame: 30 days
measure: Inflammatory markers
timeFrame: Postoperative day-1, 3, 5, 7
measure: Infectious markers
timeFrame: Postoperative day-1, 3, 5, 7
measure: Coagulation markers
timeFrame: Postoperative day-1, 3, 5, 7
measure: Fibrinolytic markers
timeFrame: Postoperative day-1, 3, 5, 7
measure: Intestinal barrier function markers
timeFrame: Postoperative day-1, 3, 5, 7
measure: General nutritional information measurement
timeFrame: Postoperative day-1, 3, 5, 7
measure: Immunological markers
timeFrame: Preoperative day-1 and postoperative day-1, 3, 5, 7
measure: Re-admission rate 30 days after discharge
timeFrame: 30 days
measure: Postoperative hospital stay
timeFrame: 1 year
measure: Postoperative ICU stay
timeFrame: 1 year
measure: Hospital costs
timeFrame: 1 year
measure: Intraoperative intestinal length
timeFrame: 30 days
measure: Type of intestinal anastomosis
timeFrame: 30 days
measure: Operation time
timeFrame: 30 days
measure: Amount of fluid input and output during operation
timeFrame: 30 days
measure: Embolus size measurement
timeFrame: 30 days
measure: Type of abdominal closure
timeFrame: 30 days
measure: Type of abdominal drainage
timeFrame: 30 days
measure: The time of nutritional support treatment
timeFrame: 30 days
measure: Degree of postoperative activity
timeFrame: 30 days
measure: Serum nutrition marker
timeFrame: Postoperative day-1, 3, 5, 7
measure: Marker of neutrophil extracellular traps markers
timeFrame: Preoperative day-1 and postoperative day-1, 3, 5, 7
measure: The composition of nutritional support treatment
timeFrame: 30 days
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jinling Hospital
state: Jiangsu
Study officials:
References: