Damage Control Surgery in Acute Mesenteric Ischemia

NCT03966430 | Unknown DMC

• 1 other identifier: 2014NZGKJ-020
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Damage Control

Keywords

damage control surgery; acute mesenteric ischemia; complication

Outcome Measures

Primary Outcomes (4)

• Postoperative 30-day mortality

  All cause mortality within 30 days

  30 days

• Rate of postoperative abdominal sepsis

  All cause postoperative abdominal infection

  30 days

• Rate of postoperative re-laparotomy

  All cause postoperative re-laparotomy

  30 days

• Postoperative short bowel syndrome rate

  All cause postoperative short bowel syndrome

  30 days

Secondary Outcomes (33)

• Rate of abdominal septic complications

  30 days

• Rate of non-abdominal septic complications

  30 days

• Rate of abdominal non-septic complications

  30 days

• Rate of systematic complications

  30 days

• Length of preoperative stay

  30 days

Study Arms (2)

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.

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.

Procedure: non-damage control surgery

Interventions

damage control surgery PROCEDURE

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.

damage control surgery group

non-damage control surgery PROCEDURE

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.

non-damage control surgery group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gao Tao: lead

Study Sites (1)

Jinling Hospital

Nanjing, Jiangsu, 210002, China

RECRUITING

Central Study Contacts

Weiwei Ding, Dr

CONTACT

15261897996; dingwei_nju@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Model Details: a single center prospective cohort study

Study Record Dates

• First Submitted: May 14, 2019
• First Posted: May 29, 2019
• Study Start: January 1, 2014
• Primary Completion: December 31, 2020
• Study Completion: March 31, 2021
• Last Updated: May 29, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)