RT Journal Article
SR Electronic
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
FD BMJ Publishing Group Ltd
SP e000777
DO 10.1136/tsaco-2021-000777
VO 6
IS 1
A1 John A Harvin
A1 Sasha D Adams
A1 Shah-Jahan M Dodwad
A1 Kayla D Isbell
A1 Claudia Pedroza
A1 Charles Green
A1 Jon E Tyson
A1 Ethan A Taub
A1 David E Meyer
A1 Laura J Moore
A1 Rondel Albarado
A1 Michelle K McNutt
A1 Lillian S Kao
A1 Charles E Wade
A1 John B Holcomb
YR 2021
UL http://tsaco.bmj.com/content/6/1/e000777.abstract
AB 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.