OGC O03 Evolution in Laparoscopic Gastrectomy from a Randomized Controlled Trial through National Clinical Practice

Abstract

Abstract Background Following Randomized Controlled Trials (RCT), the dissemination of complex interventions has been poorly studied. The LOGICA RCT included 10 Dutch centers and compared laparoscopic to open gastrectomy. The aim of this present study was to examine the influence of the LOGICA RCT upon the practice and outcomes from laparoscopic gastrectomy within the Netherlands. Methods Data were obtained from the Dutch Upper Gastrointestinal Cancer Audit (DUCA) on all gastrectomies performed in the Netherlands (2012–2021), and the LOGICA RCT from (2015–2018). Multilevel multivariable logistic regression analyses were performed to assess the effect of laparoscopic versus open gastrectomy upon clinical outcomes with the LOGICA RCT and DUCA datasets. These analyses were repeated to assess the effect of laparoscopic gastrectomy upon outcomes before, during, and after the LOGICA trial in the DUCA dataset. Results In total, 211 patients from the LOGICA RCT (105 open vs. 106 laparoscopic) and 4,131 patients from the DUCA dataset (1884 open vs. 2247 laparoscopic) were included. In 2012, laparoscopic gastrectomy was performed in 6% of patients, increasing to 82% of patients in 2021. No significant effect of laparoscopic gastrectomy on postoperative clinical outcomes was observed within the LOGICA RCT. Nationally within DUCA, a shift towards a beneficial effect of laparoscopic gastrectomy upon complications was observed, reaching a significant reduction on overall complications (aOR:0.62; 95%CI:0.46-0.82), severe complications (aOR:0.64; 95%CI:0.46-0.90) and cardiac complications (aOR:0.51; 95%CI:0.30-0.89) after the LOGICA trial. Conclusions The wider benefits of the LOGICA trial include safe dissemination of laparoscopic gastrectomy across the Netherlands. The robust surgical quality assurance programme in the design of the LOGICA RCT was crucial to facilitate the national dissemination of the technique following the trial and reducing potential patient harm during surgeons learning curve.