RT Journal Article
SR Electronic
T1 Damage control laparotomy trial: design, rationale and implementation of a randomized controlled trial
JF Trauma Surgery & Acute Care Open
FD BMJ Publishing Group Ltd
SP e000083
DO 10.1136/tsaco-2017-000083
VO 2
IS 1
A1 John A Harvin
A1 Jeanette Podbielski
A1 Laura E Vincent
A1 Erin E Fox
A1 Laura J Moore
A1 Bryan A Cotton
A1 Charles E Wade
A1 John B Holcomb
YR 2017
UL http://tsaco.bmj.com/content/2/1/e000083.abstract
AB Background Damage control laparotomy (DCL) is an abbreviated operation intended to prevent the development of hypothermia, acidosis, and coagulopathy in seriously injured patients. The indications for DCL have since been broadened with no high-quality data to guide treatment. For patients with an indication for DCL, we aim to determine the effect of definitive laparotomy on patient morbidity.Method This is a pragmatic, parallel-group, randomized controlled pilot trial. Emergent laparotomy is defined as admission directly to the operating room from the emergency department within 90 min of arrival. DCL indications excluded from the study include packing of the liver or retroperitoneum, abdominal compartment syndrome prophylaxis, to expedite interventional radiology for hemorrhage control, and the need for ongoing transfusions and/or continuous vasopressor support. When a surgeon determines a DCL is indicated, the patient will be screened for inclusion and exclusion criteria. Patients with any indication for DCL that is not excluded are eligible for randomization. Patients will be randomized intraoperatively to DCL (control) or definitive fascial closure of the laparotomy (intervention). The primary outcome will be major abdominal complication or death within 30 days. Major abdominal complication is a composite outcome including fascial dehiscence, organ/space surgical site infection, enteric suture line failure, and unplanned reopening of the abdomen. Outcomes will be compared using both frequentist and Bayesian statistics.Discussion In patients with an indication for DCL, this trial will determine the effect of definitive laparotomy on major abdominal complications and death and will inform clinicians on the risks and benefits of this procedure. Regardless of the study outcome, the results will improve the quality of care provided to injured patients.Trial registration number NCT02706041.