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Damage Control Laparotomy Trial: Design, Rationale And Open Access Brief report Trauma Surg Acute Care Open: first published as 10.1136/tsaco-2017-000083 on 13 April 2017. Downloaded from Damage control laparotomy trial: design, rationale and implementation of a randomized controlled trial John A Harvin,1,2 Jeanette Podbielski,2 Laura E Vincent,2 Erin E Fox,1,2 Laura J Moore,1,2 Bryan A Cotton,1,2 Charles E Wade,2 John B Holcomb1,2 1Department of Surgery, ABSTRACT DCL became more liberal.10 11 The morbidity asso- McGovern Medical School, Background Damage control laparotomy (DCL) is an ciated with DCL also became more evident, includ- The University of Texas Health Science Center at Houston, abbreviated operation intended to prevent the ing incisional hernia formation, enterocutaneous Houston, Texas, USA development of hypothermia, acidosis, and coagulopathy and enteroatmospheric fistula formation, superficial 2The Center for Translational in seriously injured patients. The indications for DCL and organ/space surgical site infections, organ – Injury Research, McGovern have since been broadened with no high-quality data to failure, and fascial dehiscence.12 16 Medical School, The University guide treatment. For patients with an indication for DCL, The absolute and relative clinical indications that of Texas Health Science Center fi fi at Houston, Houston, Texas, we aim to determine the effect of de nitive laparotomy have evolved over time are neither well de ned nor USA on patient morbidity. supported by any high-quality data. Indeed, expert Method This is a pragmatic, parallel-group, opinion continues to be the major determinant of Correspondence to randomized controlled pilot trial. Emergent laparotomy is appropriateness of select indications.17 18 The Dr John A Harvin, Department fi of Surgery, McGovern Medical de ned as admission directly to the operating room from majority of trauma surgeons acknowledge that School, the University of Texas the emergency department within 90 min of arrival. DCL DCL is a necessary tool for select patients despite Health Science Center at indications excluded from the study include packing of the lack of data. A major obstacle to performing Houston, 6431 Fannin Street the liver or retroperitoneum, abdominal compartment clinical trials of DCL is surgeon equipoise. This MSB 4.294 Houston, Texas syndrome prophylaxis, to expedite interventional protocol uses the information gathered from a 77030, USA; [email protected] radiology for hemorrhage control, and the need for 2-year quality improvement project at our institu- ongoing transfusions and/or continuous vasopressor tion in which a number of indications for DCL Received 30 January 2017 support. When a surgeon determines a DCL is indicated, were identified to be ones for which surgeons have Revised 19 March 2017 the patient will be screened for inclusion and exclusion clinical equipoise. Accepted 21 March 2017 criteria. Patients with any indication for DCL that is not In this parallel group, randomized controlled copyright. excluded are eligible for randomization. Patients will be trial, we compare the treatment effect of DCL randomized intraoperatively to DCL (control) or definitive versus definitive laparotomy on major abdominal fascial closure of the laparotomy (intervention). The complications (MAC) or death. We hypothesize primary outcome will be major abdominal complication that definitive laparotomy will result in lower or death within 30 days. Major abdominal complication MACs or death compared with DCL. The follow- is a composite outcome including fascial dehiscence, ing describes the design, rationale, and implementa- organ/space surgical site infection, enteric suture line tion of the DCL trial, the first clinical trial on the failure, and unplanned reopening of the abdomen. effectiveness of DCL following emergent trauma Outcomes will be compared using both frequentist and laparotomy. Bayesian statistics. Discussion In patients with an indication for DCL, this http://tsaco.bmj.com/ trial will determine the effect of definitive laparotomy on METHODS/DESIGN major abdominal complications and death and will The DCL trial is a single-center, randomized, con- inform clinicians on the risks and benefits of this trolled, pilot trial of trauma patients undergoing procedure. Regardless of the study outcome, the results emergent laparotomy following injury. This will improve the quality of care provided to injured manuscript was written in accordance to the patients. Standard Protocol Items: Recommendations for 19 Trial registration number NCT02706041. Interventional Trials (SPIRIT) 2013 guidelines. A on September 24, 2021 by guest. Protected SPIRIT diagram detailing the timing of screening, randomization, allocation, and assessment of out- BACKGROUND comes is provided in figure 1. Abbreviation of a trauma laparotomy to control hepatic bleeding or after the onset of coagulopathy was first described in 1908 and became acceptable Study setting – in the 1970s and 1980s.1 4 The term ‘damage This study is being conducted at the Red Duke control’ was used to describe a type of abbreviated Trauma Institute at Memorial Hermann laparotomy for trauma in the 1990s.5 Hospital-Texas Medical Center. The Red Duke Dissemination and implementation of damage Trauma Institute is one of two level 1 trauma To cite: Harvin JA, control laparotomy (DCL) occurred rapidly with centers in the Houston, Texas metropolitan area. Podbielski J, Vincent LE, centers across the USA publishing reports of their The trauma center’s urban location combined with et al. Trauma Surg Acute 67 ’ Care Open Published Online experience with this intervention. the fact that it is the city s only trauma center that First: [please include Day As comfort with the open abdomen necessitated receives trauma patients via aeromedical transport Month Year] doi:10.1136/ by DCL increased and as temporary abdominal results in a broad mix of urban and rural patients tsaco-2017-000083 closure devices improved,89the indications for suffering penetrating and blunt trauma. Harvin JA, et al. Trauma Surg Acute Care Open 2017;2:1–5. doi:10.1136/tsaco-2017-000083 1 Open Access Trauma Surg Acute Care Open: first published as 10.1136/tsaco-2017-000083 on 13 April 2017. Downloaded from Figure 1 SPIRIT diagram. The figure details the timing of enrollment activities, intervention allocation, and assessments of outcomes over the course of the clinical trial. SPIRIT, Standard Protocol Items: Recommendations for Interventional Trials. copyright. department in ≤90 min from initial hospital arrival. The trigger Table 1 Inclusion and exclusion criteria for the DCL trial to potentially enroll the patient is the attending surgeon’s deter- Eligible criteria must Ineligible criteria must meet at least one mination during laparotomy that the patient has an indication meet all of the following of the following criteria for DCL. The major hurdle to any clinical trial of DCL is surgeon equi- 1. Time in emergency 1. The indication for DCL is: http://tsaco.bmj.com/ department ≤90 min ▸ Need for gauze packing of liver or poise. Prior to starting the DCL trial, a 2-year, prospective 2. Admission to operating retroperitoneum quality improvement project was performed at our institution. room directly from ▸ Immediate need to go to interventional One of the aims of the project was to determine indications for emergency department or radiology for hemorrhage control DCL for which surgeons had equipoise. Indications for DCL ▸ interventional radiology Concern for abdominal compartment which lacked surgeon equipoise to perform definitive laparot- 3. Age ≥16 years syndrome—inability to reapproximate 4. Surgeon believes an fascia or >10 mm Hg increase in peak omy included: packing of the liver or retroperitoneum for hem- indication for damage airway pressure during fascial closure orrhage control; expedited transfer to interventional radiology control exists ▸ Persistent hypotension (<90 mm Hg), for hemorrhage control; abdominal compartment syndrome on September 24, 2021 by guest. Protected ongoing transfusions, and/or treatment or prophylaxis; and continuous vasopressor use, continuous vasopressor use 2. Negative or non-therapeutic laparotomy ongoing transfusions, and/or persistent hypotension. These indi- 3. Isolated cystorrhaphy cations are exclusion criteria for the DCL trial. 4. Prisoners Indications for DCL which group equipoise for definitive 5. Known pregnancy laparotomy was found included: planned second-look laparot- 6. Burns >20% total body surface area omy; expedited transfer of the patient for postoperative imaging 7. Patient or legally authorized representative has opted out of the study (eg, CT of the head to diagnose a traumatic brain injury) or intensive care; isolated acidosis without ongoing transfusions or DCL, damage control laparotomy. continuous vasopressor use; and contamination. These indica- tions are inclusion criteria for the DCL trial. Any other indica- tion not specifically excluded above will be eligible for Eligibility criteria randomization, such as prehospital/emergency department hypo- All adult trauma patients (≥16 years of age) undergoing emer- tension, hypothermia, injury patterns, operative time, estimated gent trauma laparotomy are screened for possible inclusion into blood loss, and volume of resuscitation.18 As this is a pilot study, the DCL trial (table 1). Emergent laparotomy is defined as the identification of additional indications for DCL that lack admission directly to the operating room from the emergency surgeon equipoise will help to plan a larger, multicenter
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