Damage Control Surgery in Acute Mesenteric Ischemia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Jinling Hospital, Medical School of Nanjing University

Conditions
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Damage Control

Intervention / Treatment
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* Procedure: damage control surgery
* Procedure: non-damage control surgery


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: a single center prospective cohort study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: damage control surgery group<br>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. | Procedure: damage control surgery<br>* Emergency surgery stage, (a) the hybrid operating room restores mesenteric vascular patency. (b) excision of the necrotic intestine (c) retention of suspicious intestinal ducts, double stoma (d) establishment of catheter thrombolysis pathway (e) apply TAC to maintain open abdominal. ICU phase, including (a) fluid resuscitation; (b) anti-infective and organ function support therapy; (c) continued local anticoagulation, thrombolysis (d) arrange planned re-laparotomy (e) early EN. Definitive surgical procedures, including (a) Deterministic fascia closure or further removal of the necrotic intestine. (b) Intestinal stoma care and enteral nutrition support treatment. (c) An enterostomy was performed about 6 months after the first operation.<br>|
| Sham Comparator: non-damage control surgery group<br>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. | Procedure: non-damage control surgery<br>* The patients are diagnosed with AMI and treated for mesenteric thrombosis and ischemic bowel. The patient retains the endoluminal catheter after the DSA was diagnosed as AMI. After diagnosis, the operation is performed in the general operating room, and the intestinal fistula double or the anastomosis is performed according to the judgment of the surgeon. After the operation, re-laparotomy is performed on demand.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative 30-day mortality | All cause mortality within 30 days | 30 days | 
| Rate of postoperative abdominal sepsis | All cause postoperative abdominal infection | 30 days | 
| Rate of postoperative re-laparotomy | All cause postoperative re-laparotomy | 30 days | 
| Postoperative short bowel syndrome rate | All cause postoperative short bowel syndrome | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of abdominal septic complications | Including wound infections, anastomotic leakage/anastomotic fistula, and intra-abdominal abscess | 30 days | 
| Rate of non-abdominal septic complications | Including thromboembolic complications | 30 days | 
| Rate of abdominal non-septic complications | including pneumonia and urinary tract infections | 30 days | 
| Rate of systematic complications | including thromboembolic complications | 30 days | 
| Length of preoperative stay | Number of days from admission to operation | 30 days | 
| Operative information | Including postoperative diagnosis, surgical name, surgical procedure (laparoscopic, open) | 30 days | 
| Recovery of intestinal function | first ventilation time after surgery (length in days), first defecation time (length in days), first recovery of semi-flow diet time (length in days); | 30 days | 
| The amount of nutritional support treatment | The amount (ml) of nutritional support daily | 30 days | 
| Catheter condition | whether to indwell the stomach tube (yes, no) with its extraction time (day) | 30 days | 
| Postoperative activity time | Time (hour) of getting out of bed every day after surgery; | 30 days | 
| Inflammatory markers | Serum IL-6 and CRP levels in preoperative and postoperative patients | Postoperative day-1, 3, 5, 7 | 
| Infectious markers | Pre- and post-operative patients with procalcitonin levels | Postoperative day-1, 3, 5, 7 | 
| Coagulation markers | Blood PT, APTT, INR levels before and after surgery | Postoperative day-1, 3, 5, 7 | 
| Fibrinolytic markers | Blood D-dimer, FDP levels before and after surgery | Postoperative day-1, 3, 5, 7 | 
| Intestinal barrier function markers | Urinary citrulline and I-FABP in preoperative and postoperative patients | Postoperative day-1, 3, 5, 7 | 
| General nutritional information measurement | Preoperative and postoperative patient weight (kg) and weight change (kg); | Postoperative day-1, 3, 5, 7 | 
| Immunological markers | Levels of blood T cell subsets (including CD3+ (%), CD4+ (%), and CD4+/CD8+); | Preoperative day-1 and postoperative day-1, 3, 5, 7 | 
| Re-admission rate 30 days after discharge | Re-admission time (day), cause; | 30 days | 
| Postoperative hospital stay | Number of days in hospital (day) | 1 year | 
| Postoperative ICU stay | Number of days in ICU (day) | 1 year | 
| Hospital costs | Cost from the hospital's financial system statistics (RMB) | 1 year | 
| Intraoperative intestinal length | length of intestine (length in centimetre), length of remaining intestine (length in centimetre) | 30 days | 
| Type of intestinal anastomosis | whether one-stage anastomosis (yes, no) | 30 days | 
| Operation time | operation time (hour) | 30 days | 
| Amount of fluid input and output during operation | intraoperative blood loss (ml), surgery Middle infusion volume (ml), intraoperative blood transfusion volume (ml) | 30 days | 
| Embolus size measurement | embolus size (cm) | 30 days | 
| Type of abdominal closure | (normal, temporary abdominal closure) | 30 days | 
| Type of abdominal drainage | abdominal drainage tube (yes, no) with an extraction time (day) | 30 days | 
| The time of nutritional support treatment | The start and end time of parenteral nutrition and enteral nutrition (days); | 30 days | 
| Degree of postoperative activity | Distance (m) of getting out of bed every day after surgery; | 30 days | 
| Serum nutrition marker | 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); | Postoperative day-1, 3, 5, 7 | 
| Marker of neutrophil extracellular traps markers | Levels of blood neutrophil extracellular traps markers (including CitH3 (IU/mL), cf-DNA (ng/mL), MPO-DNA (Abs405)) levels | Preoperative day-1 and postoperative day-1, 3, 5, 7 | 
| The composition of nutritional support treatment | Composition of enteral nutrition daily (%) | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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damage control surgery, acute mesenteric ischemia, complication