title: Open versus laparoscopic left lateral hepatic sectionectomy within an enhanced recovery ERAS® programme (ORANGE II-trial): study protocol for a randomised controlled trial.
abstract: BACKGROUND
  The use of lLaparoscopic liver resection in terms of time to functional recovery, length of hospital stay (LOS), long-term abdominal wall hernias, costs and quality of life (QOL) has never been studied in a randomised controlled trial. Therefore, this is the subject of the international multicentre randomised controlled ORANGE II trial.
  
  
  METHODS
  Patients eligible for left lateral sectionectomy (LLS) of the liver will be recruited and randomised at the outpatient clinic. All randomised patients will undergo surgery in the setting of an ERAS programme. The experimental design produces two randomised arms (open and laparoscopic LLS) and a prospective registry. The prospective registry will be based on patients that cannot be randomised because of the explicit treatment preference of the patient or surgeon, or because of ineligibility (not meeting the in- and exclusion criteria) for randomisation in this trial. Therefore, all non-randomised patients undergoing LLS will be approached to participate in the prospective registry, thereby allowing acquisition of an uninterrupted prospective series of patients. The primary endpoint of the ORANGE II trial is time to functional recovery. Secondary endpoints are postoperative LOS, percentage readmission, (liver-specific) morbidity, QOL, body image and cosmetic result, hospital and societal costs over 1 year, and long-term incidence of incisional hernias. It will be assumed that in patients undergoing laparoscopic LLS, length of hospital stay can be reduced by two days. A sample size of 55 patients in each randomisation arm has been calculated to detect a 2-day reduction in LOS (90% power and α = 0.05 (two-tailed)).The ORANGE II trial is a multicenter randomised controlled trial that will provide evidence on the merits of laparoscopic surgery in patients undergoing LLS within an enhanced recovery ERAS programme.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT00874224.
authors.affiliation: Department of Surgery, Maastricht University Medical Centre, Maastricht, The Netherlands. r.vandam@mumc.nl
authors.forename: Ronald M
authors.initials: RM
authors.lastname: van Dam
authors.forename: Edgar M
authors.initials: EM
authors.lastname: Wong-Lun-Hing
authors.forename: Gerard J P
authors.initials: GJ
authors.lastname: van Breukelen
authors.forename: Jan H M B
authors.initials: JH
authors.lastname: Stoot
authors.forename: Joost R
authors.initials: JR
authors.lastname: van der Vorst
authors.forename: Marc H A
authors.initials: MH
authors.lastname: Bemelmans
authors.forename: Steven W M
authors.initials: SW
authors.lastname: Olde Damink
authors.forename: Kristoffer
authors.initials: K
authors.lastname: Lassen
authors.forename: Cornelis H C
authors.initials: CH
authors.lastname: Dejong
mesh_terms: D001828:Body Image; D002921:Cicatrix / Q000209:etiology; D004311:Double-Blind Method; D005060:Europe; D006498:Hepatectomy / Q000009:adverse effects / Q000191:economics / Q000379:methods*; D046449:Hernia, Abdominal / Q000209:etiology; D017721:Hospital Costs; D006801:Humans; D010535:Laparoscopy / Q000009:adverse effects / Q000191:economics; D007902:Length of Stay; D017060:Patient Satisfaction; D011446:Prospective Studies; D011788:Quality of Life; D020127:Recovery of Function; D012042:Registries; D012107:Research Design; D013997:Time Factors; D016896:Treatment Outcome