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Open Access 01-12-2022 | Laparoscopy | Study protocol

Laparoscopic versus open resections in the posterosuperior liver segments within an enhanced recovery programme (ORANGE Segments): study protocol for a multicentre randomised controlled trial

Authors: Christoph Kuemmerli, Robert S. Fichtinger, Alma Moekotte, Luca A. Aldrighetti, Somaiah Aroori, Marc G. H. Besselink, Mathieu D’Hondt, Rafael Díaz-Nieto, Bjørn Edwin, Mikhail Efanov, Giuseppe M. Ettorre, Krishna V. Menon, Aali J. Sheen, Zahir Soonawalla, Robert Sutcliffe, Roberto I. Troisi, Steven A. White, Lloyd Brandts, Gerard J. P. van Breukelen, Jasper Sijberden, Siân A. Pugh, Zina Eminton, John N. Primrose, Ronald van Dam, Mohammed Abu Hilal, on behalf of the ORANGE trials collaborative

Published in: Trials | Issue 1/2022

Abstract

Background

A shift towards parenchymal-sparing liver resections in open and laparoscopic surgery emerged in the last few years. Laparoscopic liver resection is technically feasible and safe, and consensus guidelines acknowledge the laparoscopic approach in the posterosuperior segments. Lesions situated in these segments are considered the most challenging for the laparoscopic approach. The aim of this trial is to compare the postoperative time to functional recovery, complications, oncological safety, quality of life, survival and costs after laparoscopic versus open parenchymal-sparing liver resections in the posterosuperior liver segments within an enhanced recovery setting.

Methods

The ORANGE Segments trial is an international multicentre randomised controlled superiority trial conducted in centres experienced in laparoscopic liver resection. Eligible patients for minor resections in the posterosuperior segments will be randomised in a 1:1 ratio to undergo laparoscopic or open resections in an enhanced recovery setting. Patients and ward personnel are blinded to the treatment allocation until postoperative day 4 using a large abdominal dressing.

The primary endpoint is time to functional recovery. Secondary endpoints include intraoperative outcomes, length of stay, resection margin, postoperative complications, 90-day mortality, time to adjuvant chemotherapy initiation, quality of life and overall survival.

Laparoscopic liver surgery of the posterosuperior segments is hypothesised to reduce time to functional recovery by 2 days in comparison with open surgery. With a power of 80% and alpha of 0.04 to adjust for interim analysis halfway the trial, a total of 250 patients are required to be randomised.

Discussion

The ORANGE Segments trial is the first multicentre international randomised controlled study to compare short- and long-term surgical and oncological outcomes of laparoscopic and open resections in the posterosuperior segments within an enhanced recovery programme.

Trial registration

ClinicalTrials.gov NCT03270917. Registered on September 1, 2017. Before start of inclusion. Protocol version: version 12, May 9, 2017

Available only for authorised users

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Title: Laparoscopic versus open resections in the posterosuperior liver segments within an enhanced recovery programme (ORANGE Segments): study protocol for a multicentre randomised controlled trial
Authors: Christoph Kuemmerli
Robert S. Fichtinger
Alma Moekotte
Luca A. Aldrighetti
Somaiah Aroori
Marc G. H. Besselink
Mathieu D’Hondt
Rafael Díaz-Nieto
Bjørn Edwin
Mikhail Efanov
Giuseppe M. Ettorre
Krishna V. Menon
Aali J. Sheen
Zahir Soonawalla
Robert Sutcliffe
Roberto I. Troisi
Steven A. White
Lloyd Brandts
Gerard J. P. van Breukelen
Jasper Sijberden
Siân A. Pugh
Zina Eminton
John N. Primrose
Ronald van Dam
Mohammed Abu Hilal
on behalf of the ORANGE trials collaborative
Publication date: 01-12-2022
Publisher: BioMed Central
Keywords: Laparoscopy
Liver Surgery
Liver Resection
Liver Surgery
Liver Resection
Published in: Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-022-06112-3

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