Damage Control Surgery in Acute Mesenteric Ischemia
Primary Purpose
Damage Control
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
damage control surgery
non-damage control surgery
Sponsored by
About this trial
This is an interventional treatment trial for Damage Control focused on measuring damage control surgery, acute mesenteric ischemia, complication
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.
Sites / Locations
- Jinling HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
damage control surgery group
non-damage control surgery group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Postoperative 30-day mortality
All cause mortality within 30 days
Rate of postoperative abdominal sepsis
All cause postoperative abdominal infection
Rate of postoperative re-laparotomy
All cause postoperative re-laparotomy
Postoperative short bowel syndrome rate
All cause postoperative short bowel syndrome
Secondary Outcome Measures
Rate of abdominal septic complications
Including wound infections, anastomotic leakage/anastomotic fistula, and intra-abdominal abscess
Rate of non-abdominal septic complications
Including thromboembolic complications
Rate of abdominal non-septic complications
including pneumonia and urinary tract infections
Rate of systematic complications
including thromboembolic complications
Length of preoperative stay
Number of days from admission to operation
Operative information
Including postoperative diagnosis, surgical name, surgical procedure (laparoscopic, open)
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);
The amount of nutritional support treatment
The amount (ml) of nutritional support daily
Catheter condition
whether to indwell the stomach tube (yes, no) with its extraction time (day)
Postoperative activity time
Time (hour) of getting out of bed every day after surgery;
Inflammatory markers
Serum IL-6 and CRP levels in preoperative and postoperative patients
Infectious markers
Pre- and post-operative patients with procalcitonin levels
Coagulation markers
Blood PT, APTT, INR levels before and after surgery
Fibrinolytic markers
Blood D-dimer, FDP levels before and after surgery
Intestinal barrier function markers
Urinary citrulline and I-FABP in preoperative and postoperative patients
General nutritional information measurement
Preoperative and postoperative patient weight (kg) and weight change (kg);
Immunological markers
Levels of blood T cell subsets (including CD3+ (%), CD4+ (%), and CD4+/CD8+);
Re-admission rate 30 days after discharge
Re-admission time (day), cause;
Postoperative hospital stay
Number of days in hospital (day)
Postoperative ICU stay
Number of days in ICU (day)
Hospital costs
Cost from the hospital's financial system statistics (RMB)
Intraoperative intestinal length
length of intestine (length in centimetre), length of remaining intestine (length in centimetre)
Type of intestinal anastomosis
whether one-stage anastomosis (yes, no)
Operation time
operation time (hour)
Amount of fluid input and output during operation
intraoperative blood loss (ml), surgery Middle infusion volume (ml), intraoperative blood transfusion volume (ml)
Embolus size measurement
embolus size (cm)
Type of abdominal closure
(normal, temporary abdominal closure)
Type of abdominal drainage
abdominal drainage tube (yes, no) with an extraction time (day)
The time of nutritional support treatment
The start and end time of parenteral nutrition and enteral nutrition (days);
Degree of postoperative activity
Distance (m) of getting out of bed every day after surgery;
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);
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
The composition of nutritional support treatment
Composition of enteral nutrition daily (%)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03966430
Brief Title
Damage Control Surgery in Acute Mesenteric Ischemia
Official Title
Jinling Hospital, Medical School of Nanjing University
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2014 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
March 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Gao Tao
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Damage Control
Keywords
damage control surgery, acute mesenteric ischemia, complication
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
a single center prospective cohort study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
damage control surgery group
Arm Type
Experimental
Arm Description
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.
Arm Title
non-damage control surgery group
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
damage control surgery
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
non-damage control surgery
Intervention Description
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.
Primary Outcome Measure Information:
Title
Postoperative 30-day mortality
Description
All cause mortality within 30 days
Time Frame
30 days
Title
Rate of postoperative abdominal sepsis
Description
All cause postoperative abdominal infection
Time Frame
30 days
Title
Rate of postoperative re-laparotomy
Description
All cause postoperative re-laparotomy
Time Frame
30 days
Title
Postoperative short bowel syndrome rate
Description
All cause postoperative short bowel syndrome
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Rate of abdominal septic complications
Description
Including wound infections, anastomotic leakage/anastomotic fistula, and intra-abdominal abscess
Time Frame
30 days
Title
Rate of non-abdominal septic complications
Description
Including thromboembolic complications
Time Frame
30 days
Title
Rate of abdominal non-septic complications
Description
including pneumonia and urinary tract infections
Time Frame
30 days
Title
Rate of systematic complications
Description
including thromboembolic complications
Time Frame
30 days
Title
Length of preoperative stay
Description
Number of days from admission to operation
Time Frame
30 days
Title
Operative information
Description
Including postoperative diagnosis, surgical name, surgical procedure (laparoscopic, open)
Time Frame
30 days
Title
Recovery of intestinal function
Description
first ventilation time after surgery (length in days), first defecation time (length in days), first recovery of semi-flow diet time (length in days);
Time Frame
30 days
Title
The amount of nutritional support treatment
Description
The amount (ml) of nutritional support daily
Time Frame
30 days
Title
Catheter condition
Description
whether to indwell the stomach tube (yes, no) with its extraction time (day)
Time Frame
30 days
Title
Postoperative activity time
Description
Time (hour) of getting out of bed every day after surgery;
Time Frame
30 days
Title
Inflammatory markers
Description
Serum IL-6 and CRP levels in preoperative and postoperative patients
Time Frame
Postoperative day-1, 3, 5, 7
Title
Infectious markers
Description
Pre- and post-operative patients with procalcitonin levels
Time Frame
Postoperative day-1, 3, 5, 7
Title
Coagulation markers
Description
Blood PT, APTT, INR levels before and after surgery
Time Frame
Postoperative day-1, 3, 5, 7
Title
Fibrinolytic markers
Description
Blood D-dimer, FDP levels before and after surgery
Time Frame
Postoperative day-1, 3, 5, 7
Title
Intestinal barrier function markers
Description
Urinary citrulline and I-FABP in preoperative and postoperative patients
Time Frame
Postoperative day-1, 3, 5, 7
Title
General nutritional information measurement
Description
Preoperative and postoperative patient weight (kg) and weight change (kg);
Time Frame
Postoperative day-1, 3, 5, 7
Title
Immunological markers
Description
Levels of blood T cell subsets (including CD3+ (%), CD4+ (%), and CD4+/CD8+);
Time Frame
Preoperative day-1 and postoperative day-1, 3, 5, 7
Title
Re-admission rate 30 days after discharge
Description
Re-admission time (day), cause;
Time Frame
30 days
Title
Postoperative hospital stay
Description
Number of days in hospital (day)
Time Frame
1 year
Title
Postoperative ICU stay
Description
Number of days in ICU (day)
Time Frame
1 year
Title
Hospital costs
Description
Cost from the hospital's financial system statistics (RMB)
Time Frame
1 year
Title
Intraoperative intestinal length
Description
length of intestine (length in centimetre), length of remaining intestine (length in centimetre)
Time Frame
30 days
Title
Type of intestinal anastomosis
Description
whether one-stage anastomosis (yes, no)
Time Frame
30 days
Title
Operation time
Description
operation time (hour)
Time Frame
30 days
Title
Amount of fluid input and output during operation
Description
intraoperative blood loss (ml), surgery Middle infusion volume (ml), intraoperative blood transfusion volume (ml)
Time Frame
30 days
Title
Embolus size measurement
Description
embolus size (cm)
Time Frame
30 days
Title
Type of abdominal closure
Description
(normal, temporary abdominal closure)
Time Frame
30 days
Title
Type of abdominal drainage
Description
abdominal drainage tube (yes, no) with an extraction time (day)
Time Frame
30 days
Title
The time of nutritional support treatment
Description
The start and end time of parenteral nutrition and enteral nutrition (days);
Time Frame
30 days
Title
Degree of postoperative activity
Description
Distance (m) of getting out of bed every day after surgery;
Time Frame
30 days
Title
Serum nutrition marker
Description
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);
Time Frame
Postoperative day-1, 3, 5, 7
Title
Marker of neutrophil extracellular traps markers
Description
Levels of blood neutrophil extracellular traps markers (including CitH3 (IU/mL), cf-DNA (ng/mL), MPO-DNA (Abs405)) levels
Time Frame
Preoperative day-1 and postoperative day-1, 3, 5, 7
Title
The composition of nutritional support treatment
Description
Composition of enteral nutrition daily (%)
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weiwei Ding, Dr
Phone
15261897996
Email
dingwei_nju@hotmail.com
Facility Information:
Facility Name
Jinling Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jieshou Li, MD
Phone
025-80863337
Email
njlijieshou@126.com
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
IPD can be shared with the consent of the hospital patient information management department and the clinical trial leader.
Learn more about this trial
Damage Control Surgery in Acute Mesenteric Ischemia
We'll reach out to this number within 24 hrs