Damage Control Surgery in Acute Mesenteric Ischemia

Damage Control Clinical Trial

Official title:

Jinling Hospital, Medical School of Nanjing University

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03966430
• Other study ID #: 2014NZGKJ-020
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2014
• Est. completion date: March 31, 2021

Study information

• Verified date: May 2019
• Source: Nanjing PLA General Hospital
• Contact: Weiwei Ding, Dr
• Phone: 15261897996
• Email: dingwei_nju[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Damage Control
• Mesenteric Ischemia

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Jinling Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Gao Tao

Country where clinical trial is conducted

China, 

Outcome

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