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- #TRAUMA CENTER SECOND OPINION GREEN ROOM BACKGROUND TRIAL#
- #TRAUMA CENTER SECOND OPINION GREEN ROOM BACKGROUND MAC#
Patients were included if they had an indication for DCL for which there was surgeon equipoise, including: (1) planned second look laparotomy, (2) planned second reoperation for abdominal contamination, (3) expedition of time to postoperative CT, (4) expedition of time to postoperative intensive care or (5) of isolated metabolic acidosis in the absence of ongoing transfusions or hypotension. Emergency laparotomy was defined as: (1) time in emergency department (ED) ≤90 min and (2) admission directly to the operating room from the ED or interventional radiology. All trauma patients ≥16 years of age who underwent emergency laparotomy were screened.
#TRAUMA CENTER SECOND OPINION GREEN ROOM BACKGROUND TRIAL#
The trial was paused from Jthrough Decemfor safety evaluation by the Data Safety and Monitoring Board and Institutional Review Board. The study began on Jand ended on May 31, 2019. Patients were enrolled at the Red Duke Trauma Institute at Memorial Hermann Hospital-Texas Medical Center, which admits >6000 adult trauma patients per year and is one of two American College of Surgeons verified level 1 trauma centers in Houston, Texas, USA. 12 Patients were only included if they or their legally authorized representative consented to further participation.
#TRAUMA CENTER SECOND OPINION GREEN ROOM BACKGROUND MAC#
We hypothesized that randomization during an emergency trauma laparotomy would be feasible and that DEF in our center would be associated with fewer MAC or death within 30 days.Īn EFIC was obtained from the Institutional Review Board to randomize patients into the trial during emergency trauma laparotomy. The current pilot RCT had two aims: (1) to determine the feasibility of randomizing patients with severe abdominal trauma for whom surgeons had equipoise for DCL or definitive laparotomy (DEF) during emergency laparotomy and (2) to estimate the effect of DEF relative to DCL on the composite outcome of major abdominal complications (MAC) or death that might inform a larger definitive multicenter trial. 8–10 Barriers to performing a randomized controlled trial (RCT) of DCL include a lack of equipoise about the indications and effectiveness of DCL, and the need for exception from informed consent (EFIC) to randomize patients during emergency surgery. Current indications for DCL are driven by expert opinion as opposed to high quality evidence. However, both the initial studies supporting the benefits of DCL and the subsequent studies suggesting harm have been limited by different inclusion and exclusion criteria and selection bias inherent to observational studies. 3 4 However, when used liberally, DCL may result in more risks than benefits, as several studies from trauma centers across the country have reported increased complications associated with the open abdomen resulting from DCL.
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1 2 As comfort with the open abdomen has increased, indications for DCL have gradually broadened and its use has reached upward of 40% of all trauma laparotomies at some centers. DCL was originally described for very narrow and limited indications. Damage control laparotomy (DCL) is commonly performed and may be life-saving for patients with severe abdominal trauma.