The University of Southampton
University of Southampton Institutional Repository

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

Open versus laparoscopic left lateral hepatic sectionectomy within an enhanced recovery ERAS® programme (ORANGE II-trial): study protocol for a randomised controlled trial
Open versus laparoscopic left lateral hepatic sectionectomy within an enhanced recovery ERAS® programme (ORANGE II-trial): study protocol for a randomised controlled trial
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 ? = 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.
laparoscopy, open liver resection, hepatectomy, ERAS, left lateral sectionectomy, RCT
1745-6215
van Dam, Ronald M.
7523218d-f43b-4c5c-9117-b4e22649eab3
Wong-Lun-Hing, Edgar M.
985b30ac-325d-40b8-a45a-c8f06ba9d774
van Breukelen, Gerard J. P.
8379c2c7-5462-4b8e-8195-178bb03ce6e9
Stoot, Jan H. M. B.
9c14b0f7-f667-411e-9553-5ef618b630ac
van der Vorst, Joost R.
76f8ad7e-747e-4d7a-b377-e98a13da3494
Bemelmans, Marc H. A.
9b73c125-896c-4865-b813-d26d69cecec3
Olde Damink, Steven W. M.
504fcca4-2739-494f-a203-70f0d756d3f7
Lassen, Kristoffer
62391c12-abf8-4f6e-94ae-719ed1dedc70
Dejong, Cornelis H. C.
82dea799-a6e2-46ab-9311-c537581cba18
Primrose, J.N.
d85f3b28-24c6-475f-955b-ec457a3f9185
van Dam, Ronald M.
7523218d-f43b-4c5c-9117-b4e22649eab3
Wong-Lun-Hing, Edgar M.
985b30ac-325d-40b8-a45a-c8f06ba9d774
van Breukelen, Gerard J. P.
8379c2c7-5462-4b8e-8195-178bb03ce6e9
Stoot, Jan H. M. B.
9c14b0f7-f667-411e-9553-5ef618b630ac
van der Vorst, Joost R.
76f8ad7e-747e-4d7a-b377-e98a13da3494
Bemelmans, Marc H. A.
9b73c125-896c-4865-b813-d26d69cecec3
Olde Damink, Steven W. M.
504fcca4-2739-494f-a203-70f0d756d3f7
Lassen, Kristoffer
62391c12-abf8-4f6e-94ae-719ed1dedc70
Dejong, Cornelis H. C.
82dea799-a6e2-46ab-9311-c537581cba18
Primrose, J.N.
d85f3b28-24c6-475f-955b-ec457a3f9185

van Dam, Ronald M., Wong-Lun-Hing, Edgar M., van Breukelen, Gerard J. P., Stoot, Jan H. M. B., van der Vorst, Joost R., Bemelmans, Marc H. A., Olde Damink, Steven W. M., Lassen, Kristoffer, Dejong, Cornelis H. C. and Primrose, J.N. (2012) Open versus laparoscopic left lateral hepatic sectionectomy within an enhanced recovery ERAS® programme (ORANGE II-trial): study protocol for a randomised controlled trial. Trials, 13 (54). (doi:10.1186/1745-6215-13-54). (PMID:19561476)

Record type: Article

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 ? = 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.

Full text not available from this repository.

More information

Published date: 6 May 2012
Keywords: laparoscopy, open liver resection, hepatectomy, ERAS, left lateral sectionectomy, RCT
Organisations: Cancer Sciences, Clinical Trials Unit

Identifiers

Local EPrints ID: 350705
URI: https://eprints.soton.ac.uk/id/eprint/350705
ISSN: 1745-6215
PURE UUID: 315af74c-7bd0-4e95-95c6-8a50c9af4bc2
ORCID for J.N. Primrose: ORCID iD orcid.org/0000-0002-2069-7605

Catalogue record

Date deposited: 03 Apr 2013 11:48
Last modified: 06 Jun 2018 13:06

Export record

Altmetrics

Contributors

Author: Ronald M. van Dam
Author: Edgar M. Wong-Lun-Hing
Author: Gerard J. P. van Breukelen
Author: Jan H. M. B. Stoot
Author: Joost R. van der Vorst
Author: Marc H. A. Bemelmans
Author: Steven W. M. Olde Damink
Author: Kristoffer Lassen
Author: Cornelis H. C. Dejong
Author: J.N. Primrose ORCID iD

University divisions

Download statistics

Downloads from ePrints over the past year. Other digital versions may also be available to download e.g. from the publisher's website.

View more statistics

Atom RSS 1.0 RSS 2.0

Contact ePrints Soton: eprints@soton.ac.uk

ePrints Soton supports OAI 2.0 with a base URL of https://eprints.soton.ac.uk/cgi/oai2

This repository has been built using EPrints software, developed at the University of Southampton, but available to everyone to use.

We use cookies to ensure that we give you the best experience on our website. If you continue without changing your settings, we will assume that you are happy to receive cookies on the University of Southampton website.

×