Damage control laparotomy in trauma: a pilot randomized controlled trial. The DCL trial
| Autor: | David E. Meyer, Claudia Pedroza, Laura J. Moore, Rondel Albarado, Kayla D. Isbell, John A. Harvin, Charles E. Wade, Shah-Jahan M. Dodwad, Michelle K. McNutt, Ethan A. Taub, Lillian S. Kao, John B. Holcomb, Sasha D. Adams, Charles Green, Jon E. Tyson |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
medicine.medical_specialty
RD1-811 medicine.medical_treatment Critical Care and Intensive Care Medicine Single Center 01 natural sciences law.invention 03 medical and health sciences 0302 clinical medicine laparotomy Randomized controlled trial law Laparotomy Multicenter trial Internal medicine postoperative complications Medicine 0101 mathematics Original Research abdominal injuries business.industry RC86-88.9 010102 general mathematics Damage control laparotomy 030208 emergency & critical care medicine Medical emergencies. Critical care. Intensive care. First aid medicine.disease Abdominal trauma Relative risk emergency treatment Injury Severity Score Surgery business |
| Zdroj: | Trauma Surgery & Acute Care Open, Vol 6, Iss 1 (2021) Trauma Surgery & Acute Care Open |
| ISSN: | 2397-5776 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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