NCT00874224.

Trial name or title	Open versus laparoscopic left lateral hepatic sectionectomy within an enhanced recovery ERASW programme (ORANGE II – Trial): study protocol for a randomised controlled trial.
Methods	The ORANGE‐II trial is a multi‐centred, prospective, randomised, controlled, parallel‐group superiority trial with a double‐blinded experimental and a prospective registry design to determine whether laparoscopic surgery is to be preferred over open surgery in patients undergoing a left lateral hepatic sectionectomy within an enhanced recovery programme. The experimental design produces 2 randomised arms: (a) open LLS and (b) laparoscopic LLS. Two additional registry arms will be based on surgeons/patients that do not want to be randomised because they have an explicit preference for either the laparoscopic LLS (c), or for the open LLS (d).
Participants	Inclusion criteria: Patients suitable for undergoing both laparoscopic left lateral sectionectomy as well as open left lateral sectionectomy of the liver Able to understand the nature of the study and what will be required of them Men and non‐pregnant, non‐lactating women between age 18 and 80 BMI between 18 and 35 Patients with ASA I‐II‐III. Exclusion criteria: Inability to give written informed consent Patients undergoing liver resection other than left lateral hepatic sectionectomy Patients with ASA IV‐V Underlying liver disease.
Interventions	The experimental design produces 2 randomised arms: Procedure: laparoscopic left lateral hepatic sectionectomy. Procedure: open left lateral hepatic sectionectomy.
Outcomes	The primary outcome of the ORANGE II trial is time to functional recovery. The functional recovery criteria consist of adequate pain control with oral analgesics only, mobility restored to an independent level, absence of intravenous fluid administration, ability to eat solid foods and finally a normal or decreasing serum bilirubin level. A patient is fully functionally recovered when all of the 5 criteria are satisfied. Secondary outcomes of this trial are postoperative length of hospital stay, readmission percentage, (liver‐specific) morbidity, quality of life, body image and cosmetic result, hospital and societal costs during 1 year and long‐term incidence of incisional hernias.
Starting date	January 2010
Contact information	Contact: Ronald M van Dam, MD Phone: +31 433876543 r.vandam@mumc.nl
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