Damage Control Surgery in Acute Mesenteric Ischemia

Jinling Hospital, Medical School of Nanjing University

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.

Study Overview

• Status: Unknown
• Conditions: Damage Control
• Intervention / Treatment: Procedure: damage control surgery; Procedure: non-damage control surgery

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Weiwei Ding, Dr; Phone Number: 15261897996; Email: dingwei_nju@hotmail.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210002
      • Recruiting
      • Jinling Hospital
      • Contact: Jieshou Li, MD; Phone Number: 025-80863337; Email: njlijieshou@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: damage control surgery group; 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; 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.
Sham Comparator: non-damage control surgery group; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Gao Tao

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): March 31, 2021

Study Registration Dates

• First Submitted: May 14, 2019
• First Submitted That Met QC Criteria: May 25, 2019
• First Posted (Actual): May 29, 2019

Study Record Updates

• Last Update Posted (Actual): May 29, 2019
• Last Update Submitted That Met QC Criteria: May 25, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: complication; damage control surgery; acute mesenteric ischemia
• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Peritoneal Diseases; Gastrointestinal Diseases; Intestinal Diseases; Mesenteric Ischemia
• Other Study ID Numbers: 2014NZGKJ-020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: IPD can be shared with the consent of the hospital patient information management department and the clinical trial leader.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No