Randomized Clinical Trial of Laparoscopic versus Open Hemihepatectomy within an Enhanced Recovery after Surgery Program (ORANGE-II-PLUS Study): A Quality of Life Analysis

Introduction: Despite the large impact on Health-related Quality-of-Life (HRQoL) of major hepatectomy, the possible benefits of minimal invasive techniques on short and long-term HRQoL after major hepatectomy are unclear. The international multicenter ORANGE-II-PLUS trial compared laparoscopic (LH) and open hemihepatectomy (OH) aiming to show a reduction in Time to Functional Recovery after LH. This substudy assesses improved HRQoL after LH compared to OH in a randomized controlled setting. Methods: In the ORANGE-II-PLUS trial, patients were randomly assigned to either open or laparoscopic hemihepatectomy in 1:1 ratio. HRQoL was assessed using EORTC-QLQ-C30 with the added liver disease specific QLQ-LMC21 module. For further exploration, body image was assessed using a validated body image and cosmesis questionnaire. Data were collected at baseline and discharge, and at 10-days, 3 months, 6 months and 1 year after discharge. Global Health Status (GHS) was selected as primary HRQoL endpoint. To detect a 10 point difference in GHS after LH, with a 2-sided α=0.05 and 90% power; 172 patients were required, which amply fits within the sample size of the ORANGE-II-PLUS trial. All differences over time were compared using a linear mixed model. Results: 352 eligible patients were randomly assigned to LH (n=177) or OH (n=175), from October 2013 to January 2019. Excluding drop-outs, ITT-analysis included 332 patients (LH n=166 vs OH n=166). HRQoL Data are analyzed in the nearby future. Conclusion: An ITT-analysis of HRQoL outcomes will be performed around August 25th 2021. Results will be available as late-breaking abstract before start of IHPBA 2022.