- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03966430
Damage Control Surgery in Acute Mesenteric Ischemia
Jinling Hospital, Medical School of Nanjing University
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Weiwei Ding, Dr
- Phone Number: 15261897996
- Email: dingwei_nju@hotmail.com
Study Locations
-
-
Jiangsu
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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
Accepts Healthy Volunteers
Genders Eligible for Study
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)
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.
|
|
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.
|
The patients are diagnosed with AMI and treated for mesenteric thrombosis and ischemic bowel.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative 30-day mortality
Time Frame: 30 days
|
All cause mortality within 30 days
|
30 days
|
Rate of postoperative abdominal sepsis
Time Frame: 30 days
|
All cause postoperative abdominal infection
|
30 days
|
Rate of postoperative re-laparotomy
Time Frame: 30 days
|
All cause postoperative re-laparotomy
|
30 days
|
Postoperative short bowel syndrome rate
Time Frame: 30 days
|
All cause postoperative short bowel syndrome
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of abdominal septic complications
Time Frame: 30 days
|
Including wound infections, anastomotic leakage/anastomotic fistula, and intra-abdominal abscess
|
30 days
|
Rate of non-abdominal septic complications
Time Frame: 30 days
|
Including thromboembolic complications
|
30 days
|
Rate of abdominal non-septic complications
Time Frame: 30 days
|
including pneumonia and urinary tract infections
|
30 days
|
Rate of systematic complications
Time Frame: 30 days
|
including thromboembolic complications
|
30 days
|
Length of preoperative stay
Time Frame: 30 days
|
Number of days from admission to operation
|
30 days
|
Operative information
Time Frame: 30 days
|
Including postoperative diagnosis, surgical name, surgical procedure (laparoscopic, open)
|
30 days
|
Recovery of intestinal function
Time Frame: 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);
|
30 days
|
The amount of nutritional support treatment
Time Frame: 30 days
|
The amount (ml) of nutritional support daily
|
30 days
|
Catheter condition
Time Frame: 30 days
|
whether to indwell the stomach tube (yes, no) with its extraction time (day)
|
30 days
|
Postoperative activity time
Time Frame: 30 days
|
Time (hour) of getting out of bed every day after surgery;
|
30 days
|
Inflammatory markers
Time Frame: Postoperative day-1, 3, 5, 7
|
Serum IL-6 and CRP levels in preoperative and postoperative patients
|
Postoperative day-1, 3, 5, 7
|
Infectious markers
Time Frame: Postoperative day-1, 3, 5, 7
|
Pre- and post-operative patients with procalcitonin levels
|
Postoperative day-1, 3, 5, 7
|
Coagulation markers
Time Frame: Postoperative day-1, 3, 5, 7
|
Blood PT, APTT, INR levels before and after surgery
|
Postoperative day-1, 3, 5, 7
|
Fibrinolytic markers
Time Frame: Postoperative day-1, 3, 5, 7
|
Blood D-dimer, FDP levels before and after surgery
|
Postoperative day-1, 3, 5, 7
|
Intestinal barrier function markers
Time Frame: Postoperative day-1, 3, 5, 7
|
Urinary citrulline and I-FABP in preoperative and postoperative patients
|
Postoperative day-1, 3, 5, 7
|
General nutritional information measurement
Time Frame: Postoperative day-1, 3, 5, 7
|
Preoperative and postoperative patient weight (kg) and weight change (kg);
|
Postoperative day-1, 3, 5, 7
|
Immunological markers
Time Frame: Preoperative day-1 and postoperative day-1, 3, 5, 7
|
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
Time Frame: 30 days
|
Re-admission time (day), cause;
|
30 days
|
Postoperative hospital stay
Time Frame: 1 year
|
Number of days in hospital (day)
|
1 year
|
Postoperative ICU stay
Time Frame: 1 year
|
Number of days in ICU (day)
|
1 year
|
Hospital costs
Time Frame: 1 year
|
Cost from the hospital's financial system statistics (RMB)
|
1 year
|
Intraoperative intestinal length
Time Frame: 30 days
|
length of intestine (length in centimetre), length of remaining intestine (length in centimetre)
|
30 days
|
Type of intestinal anastomosis
Time Frame: 30 days
|
whether one-stage anastomosis (yes, no)
|
30 days
|
Operation time
Time Frame: 30 days
|
operation time (hour)
|
30 days
|
Amount of fluid input and output during operation
Time Frame: 30 days
|
intraoperative blood loss (ml), surgery Middle infusion volume (ml), intraoperative blood transfusion volume (ml)
|
30 days
|
Embolus size measurement
Time Frame: 30 days
|
embolus size (cm)
|
30 days
|
Type of abdominal closure
Time Frame: 30 days
|
(normal, temporary abdominal closure)
|
30 days
|
Type of abdominal drainage
Time Frame: 30 days
|
abdominal drainage tube (yes, no) with an extraction time (day)
|
30 days
|
The time of nutritional support treatment
Time Frame: 30 days
|
The start and end time of parenteral nutrition and enteral nutrition (days);
|
30 days
|
Degree of postoperative activity
Time Frame: 30 days
|
Distance (m) of getting out of bed every day after surgery;
|
30 days
|
Serum nutrition marker
Time Frame: 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);
|
Postoperative day-1, 3, 5, 7
|
Marker of neutrophil extracellular traps markers
Time Frame: 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
|
Preoperative day-1 and postoperative day-1, 3, 5, 7
|
The composition of nutritional support treatment
Time Frame: 30 days
|
Composition of enteral nutrition daily (%)
|
30 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014NZGKJ-020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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