You are here

Article Text

Article menu

Download PDFPDF

Brief report
Damage control laparotomy trial: design, rationale and implementation of a randomized controlled trial
  1. John A Harvin1,2,
  2. Jeanette Podbielski2,
  3. Laura E Vincent2,
  4. Erin E Fox1,2,
  5. Laura J Moore1,2,
  6. Bryan A Cotton1,2,
  7. Charles E Wade2,
  8. John B Holcomb1,2
  1. 1Department of Surgery, McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, Texas, USA
  2. 2The Center for Translational Injury Research, McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, Texas, USA
  1. Correspondence to Dr John A Harvin, Department of Surgery, McGovern Medical School, the University of Texas Health Science Center at Houston, 6431 Fannin Street MSB 4.294 Houston, Texas 77030, USA; John.Harvin{at}uth.tmc.edu

Abstract

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.

  • laparotomy
  • damage control
  • randomized clinical trial
  • complications of laparotomy

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/tsaco-2017-000083

Statistics from Altmetric.com

    Request Permissions

    If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.

    View Full Text

    Footnotes

    • Contributors JAH, JP, LEV, EEF, LJM, BAC, and JBH made substantial contributions to the concept and design of the clinical trial, were involved in the drafting and revising of the manuscript, gave final approval of the manuscript to be published, and agreed to be accountable for all aspects of the work.

    • Funding JAH is supported by the Center for Clinical and Translational Sciences, which is funded by the National Institutes of Health Clinical and Translational Award KL2 TR000370 from the National Center for Advancing Translational Sciences.

    • Disclaimer The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center for Advancing Translational Sciences or the National Institutes of Health.

    • Competing interests None declared.

    • Ethics approval The Institutional Review Board (IRB) of the University of Texas Health Sciences Center at Houston (UT Health) approved the study protocol.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data sharing statement No additional data are available.