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Published in: Trials 1/2012

Open Access 01-12-2012 | Study protocol

Open versus laparoscopic left lateral hepatic sectionectomy within an enhanced recovery ERAS® programme (ORANGE II – Trial): study protocol for a randomised controlled trial

Authors: Ronald M van Dam, Edgar M Wong-Lun-Hing, Gerard JP van Breukelen, Jan HMB Stoot, Joost R van der Vorst, Marc HA Bemelmans, Steven WM Olde Damink, Kristoffer Lassen, Cornelis HC Dejong, ORANGE II Study Group

Published in: Trials | Issue 1/2012

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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.

Trial registration

ClinicalTrials.gov NCT00874224.
Appendix
Available only for authorised users
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Metadata
Title
Open versus laparoscopic left lateral hepatic sectionectomy within an enhanced recovery ERAS® programme (ORANGE II – Trial): study protocol for a randomised controlled trial
Authors
Ronald M van Dam
Edgar M Wong-Lun-Hing
Gerard JP van Breukelen
Jan HMB Stoot
Joost R van der Vorst
Marc HA Bemelmans
Steven WM Olde Damink
Kristoffer Lassen
Cornelis HC Dejong
ORANGE II Study Group
Publication date
01-12-2012
Publisher
BioMed Central
Published in
Trials / Issue 1/2012
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/1745-6215-13-54

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