Damage ControlNCT03966430
Damage Control Surgery in Acute Mesenteric Ischemia
A study of Damage Control, run by Gao Tao at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Damage Control
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2014to 31 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jinling Hospital
Nanjing, Jiangsu, 210002
Jieshou Li, MD, 025-80863337, njlijieshou@126.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Damage Control
- Being tested
- damage control surgery, non-damage control surgery
- Keywords
- damage control surgery, acute mesenteric ischemia, complication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
damage control surgeryProcedure or 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 surgeryProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| damage control surgery group | Experimental | 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. Receives: Procedure: damage control surgery |
| non-damage control surgery group | Sham comparator | 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. Receives: Procedure: non-damage control surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative 30-day mortality
All cause mortality within 30 days
Measured: 30 days
Rate of postoperative abdominal sepsis
All cause postoperative abdominal infection
Measured: 30 days
Rate of postoperative re-laparotomy
All cause postoperative re-laparotomy
Measured: 30 days
Postoperative short bowel syndrome rate
All cause postoperative short bowel syndrome
Measured: 30 days
Secondary outcomes (33)
Rate of abdominal septic complications
Including wound infections, anastomotic leakage/anastomotic fistula, and intra-abdominal abscess
Measured: 30 days
Rate of non-abdominal septic complications
Including thromboembolic complications
Measured: 30 days
Rate of abdominal non-septic complications
including pneumonia and urinary tract infections
Measured: 30 days
Rate of systematic complications
including thromboembolic complications
Measured: 30 days
Length of preoperative stay
Number of days from admission to operation
Measured: 30 days
Operative information
Including postoperative diagnosis, surgical name, surgical procedure (laparoscopic, open)
Measured: 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);
Measured: 30 days
The amount of nutritional support treatment
The amount (ml) of nutritional support daily
Measured: 30 days
Catheter condition
whether to indwell the stomach tube (yes, no) with its extraction time (day)
Measured: 30 days
Postoperative activity time
Time (hour) of getting out of bed every day after surgery;
Measured: 30 days
Inflammatory markers
Serum IL-6 and CRP levels in preoperative and postoperative patients
Measured: Postoperative day-1, 3, 5, 7
Infectious markers
Pre- and post-operative patients with procalcitonin levels
Measured: Postoperative day-1, 3, 5, 7
Coagulation markers
Blood PT, APTT, INR levels before and after surgery
Measured: Postoperative day-1, 3, 5, 7
Fibrinolytic markers
Blood D-dimer, FDP levels before and after surgery
Measured: Postoperative day-1, 3, 5, 7
Intestinal barrier function markers
Urinary citrulline and I-FABP in preoperative and postoperative patients
Measured: Postoperative day-1, 3, 5, 7
General nutritional information measurement
Preoperative and postoperative patient weight (kg) and weight change (kg);
Measured: Postoperative day-1, 3, 5, 7
Immunological markers
Levels of blood T cell subsets (including CD3+ (%), CD4+ (%), and CD4+/CD8+);
Measured: Preoperative day-1 and postoperative day-1, 3, 5, 7
Re-admission rate 30 days after discharge
Re-admission time (day), cause;
Measured: 30 days
Postoperative hospital stay
Number of days in hospital (day)
Measured: 1 year
Postoperative ICU stay
Number of days in ICU (day)
Measured: 1 year
Hospital costs
Cost from the hospital's financial system statistics (RMB)
Measured: 1 year
Intraoperative intestinal length
length of intestine (length in centimetre), length of remaining intestine (length in centimetre)
Measured: 30 days
Type of intestinal anastomosis
whether one-stage anastomosis (yes, no)
Measured: 30 days
Operation time
operation time (hour)
Measured: 30 days
Amount of fluid input and output during operation
intraoperative blood loss (ml), surgery Middle infusion volume (ml), intraoperative blood transfusion volume (ml)
Measured: 30 days
Embolus size measurement
embolus size (cm)
Measured: 30 days
Type of abdominal closure
(normal, temporary abdominal closure)
Measured: 30 days
Type of abdominal drainage
abdominal drainage tube (yes, no) with an extraction time (day)
Measured: 30 days
The time of nutritional support treatment
The start and end time of parenteral nutrition and enteral nutrition (days);
Measured: 30 days
Degree of postoperative activity
Distance (m) of getting out of bed every day after surgery;
Measured: 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);
Measured: 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
Measured: Preoperative day-1 and postoperative day-1, 3, 5, 7
The composition of nutritional support treatment
Composition of enteral nutrition daily (%)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2019
- Study start1 Jan 2014
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Damage ControlStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- a single center prospective cohort study
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gao Tao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gao Tao, Nanjing PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03966430
- Sponsor's protocol ID
- 2014NZGKJ-020
- Status last verified
- May 2019
- First submitted
- 14 May 2019
- Last updated
- 29 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD can be shared with the consent of the hospital patient information management department and the clinical trial leader.
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Jinling Hospital, Medical School of Nanjing University
- ClinicalTrials.gov ID
- NCT03966430
- Acronym / sponsor ID
- 2014NZGKJ-020
- Conditions
- Damage Control
- Keywords
- damage control surgery, acute mesenteric ischemia, complication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Gao TaoUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Mar 2021 (estimated)
- First posted
- 29 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- a single center prospective cohort study
| Arm | Type | Receives |
|---|---|---|
| damage control surgery group | Experimental | Procedure: damage control surgeryAccording 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. |
| non-damage control surgery group | Sham comparator | Procedure: non-damage control surgeryAccording 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| damage control surgery1. 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. 2. 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. 3. 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. | Procedure or surgery | damage control surgery group |
| non-damage control surgeryThe patients are diagnosed with AMI and treated for mesenteric thrombosis and ischemic bowel. 1. The patient retains the endoluminal catheter after the DSA was diagnosed as AMI. 2. 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. 3. After the operation, re-laparotomy is performed on demand. | Procedure or surgery | non-damage control surgery group |
Primary outcome
Postoperative 30-day mortality
Time frame: 30 days
All cause mortality within 30 days
Rate of postoperative abdominal sepsis
Time frame: 30 days
All cause postoperative abdominal infection
Rate of postoperative re-laparotomy
Time frame: 30 days
All cause postoperative re-laparotomy
Postoperative short bowel syndrome rate
Time frame: 30 days
All cause postoperative short bowel syndrome
33 secondary outcomes
Rate of abdominal septic complications
Time frame: 30 days
Rate of non-abdominal septic complications
Time frame: 30 days
Rate of abdominal non-septic complications
Time frame: 30 days
Rate of systematic complications
Time frame: 30 days
Length of preoperative stay
Time frame: 30 days
Operative information
Time frame: 30 days
Recovery of intestinal function
Time frame: 30 days
The amount of nutritional support treatment
Time frame: 30 days
Catheter condition
Time frame: 30 days
Postoperative activity time
Time frame: 30 days
Inflammatory markers
Time frame: Postoperative day-1, 3, 5, 7
Infectious markers
Time frame: Postoperative day-1, 3, 5, 7
Coagulation markers
Time frame: Postoperative day-1, 3, 5, 7
Fibrinolytic markers
Time frame: Postoperative day-1, 3, 5, 7
Intestinal barrier function markers
Time frame: Postoperative day-1, 3, 5, 7
General nutritional information measurement
Time frame: Postoperative day-1, 3, 5, 7
Immunological markers
Time frame: Preoperative day-1 and postoperative day-1, 3, 5, 7
Re-admission rate 30 days after discharge
Time frame: 30 days
Postoperative hospital stay
Time frame: 1 year
Postoperative ICU stay
Time frame: 1 year
Hospital costs
Time frame: 1 year
Intraoperative intestinal length
Time frame: 30 days
Type of intestinal anastomosis
Time frame: 30 days
Operation time
Time frame: 30 days
Amount of fluid input and output during operation
Time frame: 30 days
Embolus size measurement
Time frame: 30 days
Type of abdominal closure
Time frame: 30 days
Type of abdominal drainage
Time frame: 30 days
The time of nutritional support treatment
Time frame: 30 days
Degree of postoperative activity
Time frame: 30 days
Serum nutrition marker
Time frame: Postoperative day-1, 3, 5, 7
Marker of neutrophil extracellular traps markers
Time frame: Preoperative day-1 and postoperative day-1, 3, 5, 7
The composition of nutritional support treatment
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2019.
- Individual participant dataSharing planned: No. IPD can be shared with the consent of the hospital patient information management department and the clinical trial leader.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Damage Control, run by Gao Tao at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Weiwei Ding, Dr (15261897996, dingwei_nju@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative 30-day mortality (time frame: 30 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2019.