Damage control laparotomy trial: design, rationale and implementation of a randomized controlled trial

Trauma Surgery & Acute Care Open
John A HarvinJ B Holcomb

Abstract

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. 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...Continue Reading

Associated Clinical Trials

Mar 11, 2016·John Andrew Harvin

References

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Citations

Jul 2, 2019·The Journal of Trauma and Acute Care Surgery·John A HarvinJohn B Holcomb
Jul 7, 2018·World Journal of Emergency Surgery : WJES·Andrew W KirkpatrickUNKNOWN Closed Or Open after Laparotomy (COOL) after Source Control for Severe Complicated Intra-Abdominal Sepsis Investigators
Aug 24, 2021·Trauma Surgery & Acute Care Open·John A HarvinJohn B Holcomb
Oct 16, 2021·World Journal of Emergency Surgery : WJES·Derek J RobertsHenry T Stelfox

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