RCT of open versus laparoscopic left lateral hepatic sectionectomy within an enhanced recovery after surgery programme (ORANGE II study)

Abstract

Background: Laparoscopic left lateral sectionectomy (LLLS) has been associated with shorter LOS and reduced overall morbidity compared with open left lateral sectionectomy (OLLS). Strong evidence has not, however, been provided. Methods: In this multicentre double-blind RCT, patients requiring left lateral sectionectomy were assigned to OLLS or LLLS within an ERAS programme. A parallel prospective registry (open non-randomized (ONR) vs laparoscopic non-randomized (LNR)) was used to monitor patients not enrolled for randomization because of doctor or patient preference. The primary endpoint was time to functional recovery (FR). Secondary endpoints were LOS, readmission rate, overall morbidity, composite endpoint of liver surgery-specific morbidity, mortality, and reasons for delay in discharge after functional recovery. Results: Patients were recruited between January 2010 - July 2014. 24 patients were randomized, and 67 patients were included in the registry. Owing to slow accrual, the trial was stopped on the advice of an independent DSMB. No significant difference in median (IQR) time to FR was observed: 3⋅0 (3–5) days for OLLS vs 3⋅0 (3–3) days for LLLS; and 3⋅0 (3–3) days for ONR vs 3⋅0 (3–4) days for LNR. There were no significant differences with regard to LOS, morbidity, reoperation, readmission and mortality rates. Conclusion: This RCT comparing open and laparoscopic LLS in an ERAS setting was not able to reach a conclusion on time to functional recovery, because it was stopped prematurely owing to slow accrual.