Damage control laparotomy in trauma: a pilot randomized controlled trial. The DCL trial

Abstract

BackgroundAlthough widely used in treating severe abdominal trauma, damage control laparotomy (DCL) has not been assessed in any randomized controlled trial. We conducted a pilot trial among patients for whom our surgeons had equipoise and hypothesized that definitive laparotomy (DEF) would reduce major abdominal complications (MAC) or death within 30 days compared with DCL.MethodsEligible patients undergoing emergency laparotomy were randomized during surgery to DCL or DEF from July 2016 to May 2019. The primary outcome was MAC or death within 30 days. Prespecified frequentist and Bayesian analyses were performed.ResultsOf 489 eligible patients, 39 patients were randomized (DCL 18, DEF 21) and included. Groups were similar in demographics and mechanism of injury. The DEF group had a higher Injury Severity Score (DEF median 34 (IQR 20, 43) vs DCL 29 (IQR 22, 41)) and received more prerandomization blood products (DEF median red blood cells 8 units (IQR 6, 11) vs DCL 6 units (IQR 2, 11)). In unadjusted analyses, the DEF group had more MAC or death within 30 days (1.71, 95% CI 0.81 to 3.63, p=0.159) due to more deaths within 30 days (DEF 33% vs DCL 0%, p=0.010). Adjustment for Injury Severity Score and prerandomization blood products reduced the risk ratio for MAC or death within 30 days to 1.54 (95% CI 0.71 to 3.32, p=0.274). The Bayesian probability that DEF increased MAC or death within 30 days was 85% in unadjusted analyses and 66% in adjusted analyses.ConclusionThe findings of our single center pilot trial were inconclusive. Outcomes were not worse with DCL and, in fact, may have been better. A randomized clinical trial of DCL is feasible and a larger, multicenter trial is needed to compare DCL and DEF for patients with severe abdominal trauma.Level of evidenceLevel II.

American Association for the Surgery of Trauma/American College of Surgeons Committee on Trauma: Clinical protocol for damage-control resuscitation for the adult trauma patient

“…111 A single-institution RCT trended toward improved outcome with damage-control laparotomy. 112 However, damage-control surgery has also been associated with significant rates of intra-abdominal infection, enterocutaneous fistula, and ventral hernia formation, including when compared with matched controls. 113 A 2016 report identified the following indications most highly associated with use of damage-control surgery: injury pattern identified during operation, inability to control hemorrhage, greater volume of resuscitation required, severity of physiologic insult, and need for staged abdominal or thoracic wall reconstruction.…”

“…High-quality data regarding when to use damage-control rather than definitive surgery are lacking, and a 2021 systematic review confirmed inadequate evidence to draw conclusions regarding indication or effectiveness 111 . A single-institution RCT trended toward improved outcome with damage-control laparotomy 112 . However, damage-control surgery has also been associated with significant rates of intra-abdominal infection, enterocutaneous fistula, and ventral hernia formation, including when compared with matched controls 113 .…”

Das Abdominaltrauma

“…Die Durchführenden stellten die Hypothese auf, dass durch eine definitive Versorgung die Rate an abdominellen Major-Komplikationen reduziert werden könne. Tatsächlich zeigte sich jedoch in der Studienpopulation ein tendenziell besseres Outcome der DCS-Gruppe bei geringerer 30-Tage-Morbidität und -Mortalität 14 .…”