title: Randomized clinical trial 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 hospital stay 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 (aged 18-80 years with a BMI of 18-35 kg/m2and ASA fitness grade of III or below) requiring left lateral sectionectomy (LLS) were assigned randomly to OLLS or LLLS within an enhanced recovery after surgery (ERAS) programme. All randomized patients, ward physicians and nurses were blinded to the procedure undertaken. A parallel prospective registry (open non-randomized (ONR) versus laparoscopic non-randomized (LNR)) was used to monitor patients who were not enrolled for randomization because of doctor or patient preference. The primary endpoint was time to functional recovery. Secondary endpoints were length of hospital stay (LOS), readmission rate, overall morbidity, composite endpoint of liver surgery-specific morbidity, mortality, and reasons for delay in discharge after functional recovery.
  
  
  RESULTS
  Between January 2010 and July 2014, patients were recruited at ten centres. Of these, 24 patients were randomized at eight centres, and 67 patients from eight centres were included in the prospective registry. Owing to slow accrual, the trial was stopped on the advice of an independent Data and Safety Monitoring Board in the Netherlands. No significant difference in median (i.q.r.) time to functional recovery was observed between laparoscopic and open surgery in the randomized or non-randomized groups: 3 (3-5) days for OLLS versus 3 (3-3) days for LLLS; and 3 (3-3) days for ONR versus 3 (3-4) days for LNR. There were no significant differences with regard to LOS, morbidity, reoperation, readmission and mortality rates.
  
  
  CONCLUSIONS
  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. Registration number: NCT00874224 ( https://www.clinicaltrials.gov).
authors.affiliation: Department of Surgery, Maastricht University Medical Centre, Maastricht, The Netherlands.|Nutrim School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre, Maastricht, The Netherlands.
authors.forename: E M
authors.initials: EM
authors.lastname: Wong-Lun-Hing
authors.affiliation: Department of Surgery, Maastricht University Medical Centre, Maastricht, The Netherlands.|Department of Surgery, University Hospital Aachen, Aachen, Germany.
authors.forename: R M
authors.initials: RM
authors.lastname: van Dam
authors.affiliation: Department of Methodology and Statistics, Maastricht University Medical Centre, Maastricht, The Netherlands.|CAPHRI School for Public Health and Primary Care, Maastricht University Medical Centre, Maastricht, The Netherlands.
authors.forename: G J P
authors.initials: GJ
authors.lastname: van Breukelen
authors.affiliation: Department of Surgery, Academic Medical Centre, Amsterdam, The Netherlands.
authors.forename: P J
authors.initials: PJ
authors.lastname: Tanis
authors.affiliation: Department of Surgery, San Raffaele Hospital, Milan, Italy.
authors.forename: F
authors.initials: F
authors.lastname: Ratti
authors.affiliation: Department of Surgery, University Medical Centre Utrecht, Utrecht, The Netherlands.
authors.forename: R
authors.initials: R
authors.lastname: van Hillegersberg
authors.affiliation: Department of Surgery, Maxima Medical Centre, Veldhoven, The Netherlands.
authors.forename: G D
authors.initials: GD
authors.lastname: Slooter
authors.affiliation: Department of Surgery, Radboud University Medical Centre, Nijmegen, The Netherlands.
authors.forename: J H W
authors.initials: JH
authors.lastname: de Wilt
authors.affiliation: Department of Surgery, Deventer Hospital, Deventer, The Netherlands.
authors.forename: M S L
authors.initials: MS
authors.lastname: Liem
authors.affiliation: Department of Surgery, University Medical Centre Groningen, Groningen, The Netherlands.
authors.forename: M T
authors.initials: MT
authors.lastname: de Boer
authors.affiliation: Department of Surgery, Medisch Spectrum Twente, Enschede, The Netherlands.
authors.forename: J M
authors.initials: JM
authors.lastname: Klaase
authors.affiliation: Department of Surgery, Maastricht University Medical Centre, Maastricht, The Netherlands.|Department of Surgery, University Hospital Aachen, Aachen, Germany.
authors.forename: U P
authors.initials: UP
authors.lastname: Neumann
authors.affiliation: Department of Surgery, San Raffaele Hospital, Milan, Italy.
authors.forename: L A
authors.initials: LA
authors.lastname: Aldrighetti
authors.affiliation: Department of Surgery, Maastricht University Medical Centre, Maastricht, The Netherlands.|Nutrim School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre, Maastricht, The Netherlands.|GROW - School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht, The Netherlands.|Department of Surgery, University Hospital Aachen, Aachen, Germany.
authors.forename: C H C
authors.initials: CH
authors.lastname: Dejong
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004311:Double-Blind Method; D005260:Female; D006498:Hepatectomy / Q000009:adverse effects / Q000379:methods*; D006801:Humans; D010535:Laparoscopy / Q000009:adverse effects / Q000379:methods*; D007902:Length of Stay / Q000706:statistics & numerical data; D008099:Liver / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012042:Registries; D016896:Treatment Outcome; D055815:Young Adult