TY - JOUR T1 - Damage control laparotomy in trauma: a pilot randomized controlled trial. The DCL trial JF - Trauma Surgery & Acute Care Open JO - Trauma Surg Acute Care Open DO - 10.1136/tsaco-2021-000777 VL - 6 IS - 1 SP - e000777 AU - John A Harvin AU - Sasha D Adams AU - Shah-Jahan M Dodwad AU - Kayla D Isbell AU - Claudia Pedroza AU - Charles Green AU - Jon E Tyson AU - Ethan A Taub AU - David E Meyer AU - Laura J Moore AU - Rondel Albarado AU - Michelle K McNutt AU - Lillian S Kao AU - Charles E Wade AU - John B Holcomb Y1 - 2021/07/01 UR - http://tsaco.bmj.com/content/6/1/e000777.abstract N2 - Background Although 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.Methods Eligible 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.Results Of 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.Conclusion The 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 evidence Level II.No data are available. No data will be provided. ER -