Damage Control Surgery in Acute Mesenteric Ischemia
- Conditions
- Damage Control
- Interventions
- Procedure: damage control surgeryProcedure: non-damage control surgery
- Registration Number
- NCT03966430
- Lead Sponsor
- Gao Tao
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description damage control surgery group damage control surgery 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. non-damage control surgery group non-damage control surgery 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.
- Primary Outcome Measures
Name Time Method Rate of postoperative abdominal sepsis 30 days All cause postoperative abdominal infection
Postoperative short bowel syndrome rate 30 days All cause postoperative short bowel syndrome
Postoperative 30-day mortality 30 days All cause mortality within 30 days
Rate of postoperative re-laparotomy 30 days All cause postoperative re-laparotomy
- Secondary Outcome Measures
Name Time Method Recovery of intestinal function 30 days first ventilation time after surgery (length in days), first defecation time (length in days), first recovery of semi-flow diet time (length in days);
Postoperative activity time 30 days Time (hour) of getting out of bed every day after surgery;
Coagulation markers Postoperative day-1, 3, 5, 7 Blood PT, APTT, INR levels before and after surgery
Rate of abdominal septic complications 30 days Including wound infections, anastomotic leakage/anastomotic fistula, and intra-abdominal abscess
Rate of non-abdominal septic complications 30 days Including thromboembolic complications
Infectious markers Postoperative day-1, 3, 5, 7 Pre- and post-operative patients with procalcitonin levels
Rate of abdominal non-septic complications 30 days including pneumonia and urinary tract infections
Rate of systematic complications 30 days including thromboembolic complications
Length of preoperative stay 30 days Number of days from admission to operation
Operative information 30 days Including postoperative diagnosis, surgical name, surgical procedure (laparoscopic, open)
General nutritional information measurement Postoperative day-1, 3, 5, 7 Preoperative and postoperative patient weight (kg) and weight change (kg);
Immunological markers Preoperative day-1 and postoperative day-1, 3, 5, 7 Levels of blood T cell subsets (including CD3+ (%), CD4+ (%), and CD4+/CD8+);
Hospital costs 1 year Cost from the hospital's financial system statistics (RMB)
Intraoperative intestinal length 30 days length of intestine (length in centimetre), length of remaining intestine (length in centimetre)
Re-admission rate 30 days after discharge 30 days Re-admission time (day), cause;
Postoperative hospital stay 1 year Number of days in hospital (day)
Type of intestinal anastomosis 30 days whether one-stage anastomosis (yes, no)
The amount of nutritional support treatment 30 days The amount (ml) of nutritional support daily
Catheter condition 30 days whether to indwell the stomach tube (yes, no) with its extraction time (day)
Inflammatory markers Postoperative day-1, 3, 5, 7 Serum IL-6 and CRP levels in preoperative and postoperative patients
Amount of fluid input and output during operation 30 days intraoperative blood loss (ml), surgery Middle infusion volume (ml), intraoperative blood transfusion volume (ml)
Degree of postoperative activity 30 days Distance (m) of getting out of bed every day after surgery;
Serum nutrition marker Postoperative day-1, 3, 5, 7 Preoperative and postoperative serum albumin (g/L), prealbumin (mg/L), transferrin (g/L), hemoglobin (g/L), white blood cell count (10\^9/L), platelet count (10\^9/L), and hematocrit (L/L);
Fibrinolytic markers Postoperative day-1, 3, 5, 7 Blood D-dimer, FDP levels before and after surgery
Type of abdominal drainage 30 days abdominal drainage tube (yes, no) with an extraction time (day)
The composition of nutritional support treatment 30 days Composition of enteral nutrition daily (%)
Intestinal barrier function markers Postoperative day-1, 3, 5, 7 Urinary citrulline and I-FABP in preoperative and postoperative patients
Postoperative ICU stay 1 year Number of days in ICU (day)
Operation time 30 days operation time (hour)
Embolus size measurement 30 days embolus size (cm)
The time of nutritional support treatment 30 days The start and end time of parenteral nutrition and enteral nutrition (days);
Type of abdominal closure 30 days (normal, temporary abdominal closure)
Marker of neutrophil extracellular traps markers Preoperative day-1 and postoperative day-1, 3, 5, 7 Levels of blood neutrophil extracellular traps markers (including CitH3 (IU/mL), cf-DNA (ng/mL), MPO-DNA (Abs405)) levels
Trial Locations
- Locations (1)
Jinling Hospital
🇨🇳Nanjing, Jiangsu, China