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Damage Control Surgery in Acute Mesenteric Ischemia

Jinling Hospital, Medical School of Nanjing University

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03966430
Enrollment
60
Registered
2019-05-29
Start date
2014-01-01
Completion date
2021-03-31
Last updated
2019-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Damage Control

Keywords

damage control surgery, acute mesenteric ischemia, complication

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.

Interventions

1. 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.

PROCEDUREnon-damage control surgery

The 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.

Sponsors

Gao Tao
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

a single center prospective cohort study

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Postoperative 30-day mortality30 daysAll cause mortality within 30 days
Rate of postoperative abdominal sepsis30 daysAll cause postoperative abdominal infection
Rate of postoperative re-laparotomy30 daysAll cause postoperative re-laparotomy
Postoperative short bowel syndrome rate30 daysAll cause postoperative short bowel syndrome

Secondary

MeasureTime frameDescription
Length of preoperative stay30 daysNumber of days from admission to operation
Operative information30 daysIncluding postoperative diagnosis, surgical name, surgical procedure (laparoscopic, open)
Recovery of intestinal function30 daysfirst 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 treatment30 daysThe amount (ml) of nutritional support daily
Catheter condition30 dayswhether to indwell the stomach tube (yes, no) with its extraction time (day)
Postoperative activity time30 daysTime (hour) of getting out of bed every day after surgery;
Inflammatory markersPostoperative day-1, 3, 5, 7Serum IL-6 and CRP levels in preoperative and postoperative patients
Infectious markersPostoperative day-1, 3, 5, 7Pre- and post-operative patients with procalcitonin levels
Coagulation markersPostoperative day-1, 3, 5, 7Blood PT, APTT, INR levels before and after surgery
Fibrinolytic markersPostoperative day-1, 3, 5, 7Blood D-dimer, FDP levels before and after surgery
Intestinal barrier function markersPostoperative day-1, 3, 5, 7Urinary citrulline and I-FABP in preoperative and postoperative patients
General nutritional information measurementPostoperative day-1, 3, 5, 7Preoperative and postoperative patient weight (kg) and weight change (kg);
Immunological markersPreoperative day-1 and postoperative day-1, 3, 5, 7Levels of blood T cell subsets (including CD3+ (%), CD4+ (%), and CD4+/CD8+);
Re-admission rate 30 days after discharge30 daysRe-admission time (day), cause;
Rate of abdominal septic complications30 daysIncluding wound infections, anastomotic leakage/anastomotic fistula, and intra-abdominal abscess
Postoperative ICU stay1 yearNumber of days in ICU (day)
Hospital costs1 yearCost from the hospital's financial system statistics (RMB)
Intraoperative intestinal length30 dayslength of intestine (length in centimetre), length of remaining intestine (length in centimetre)
Type of intestinal anastomosis30 dayswhether one-stage anastomosis (yes, no)
Operation time30 daysoperation time (hour)
Amount of fluid input and output during operation30 daysintraoperative blood loss (ml), surgery Middle infusion volume (ml), intraoperative blood transfusion volume (ml)
Embolus size measurement30 daysembolus size (cm)
Type of abdominal closure30 days(normal, temporary abdominal closure)
Type of abdominal drainage30 daysabdominal drainage tube (yes, no) with an extraction time (day)
The time of nutritional support treatment30 daysThe start and end time of parenteral nutrition and enteral nutrition (days);
Degree of postoperative activity30 daysDistance (m) of getting out of bed every day after surgery;
Serum nutrition markerPostoperative day-1, 3, 5, 7Preoperative 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 markersPreoperative day-1 and postoperative day-1, 3, 5, 7Levels of blood neutrophil extracellular traps markers (including CitH3 (IU/mL), cf-DNA (ng/mL), MPO-DNA (Abs405)) levels
The composition of nutritional support treatment30 daysComposition of enteral nutrition daily (%)
Postoperative hospital stay1 yearNumber of days in hospital (day)
Rate of non-abdominal septic complications30 daysIncluding thromboembolic complications
Rate of abdominal non-septic complications30 daysincluding pneumonia and urinary tract infections
Rate of systematic complications30 daysincluding thromboembolic complications

Countries

China

Contacts

Primary ContactWeiwei Ding, Dr
dingwei_nju@hotmail.com15261897996

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026