Kuemmerli, Christoph
Fichtinger, Robert S.
Moekotte, Alma
Aldrighetti, Luca A.
Aroori, Somaiah
Besselink, Marc G. H.
D’Hondt, Mathieu
Díaz-Nieto, Rafael
Edwin, Bjørn
Efanov, Mikhail
Ettorre, Giuseppe M.
Menon, Krishna V.
Sheen, Aali J.
Soonawalla, Zahir
Sutcliffe, Robert
Troisi, Roberto I.
White, Steven A.
Brandts, Lloyd
van Breukelen, Gerard J. P.
Sijberden, Jasper
Pugh, Siân A.
Eminton, Zina
Primrose, John N.
van Dam, Ronald
Hilal, Mohammed Abu
,
Funding for this research was provided by:
Ethicon Endo-Surgery (1210958)
Cancer Research UK (C317/A16248)
Article History
Received: 18 May 2021
Accepted: 15 February 2022
First Online: 9 March 2022
Declarations
:
: The ORANGE Segments trial is an extension of the ORANGE II PLUS protocol. The first approved version was version 7. With version 8, the protocol was changed to the latest CCMO model protocol and the study start and end dates were updated. In version 9, a risk analysis was added, and in version 10, the upper age limit was removed. The amendment containing the ORANGE Segments extension was approved on May 9, 2017, by the Medical Research Ethics Committee of the Maastricht University Medical Centre+, Maastricht, the Netherlands, under trial number NL36215.068.11 / MEC 11-2-028. Ethical consent has been obtained in the following countries: in the UK under reference 13/SC/0530, in Belgium under reference B670201318009, in Italy under reference 01/2015, NP3437 and 908/CE, in Norway under reference 2014/1759 and in Russia under reference 3/2019. No amendments have been made to the protocol since May 9, 2017, when the amendment to add the two ORANGE Segments groups to the ORANGE II PLUS protocol was approved.A two-time consent is carried out. Candidate patients are informed about the study by their treating surgeon in the outpatient clinic. If the patient is willing to participate, both verbal and written information at the time of recruitment is provided by the principal investigator or an authorised researcher. After at least 24 h of reflection, a written informed consent is obtained. With this consent, the patient is randomised. Before surgery, another informed consent regarding all further study-related procedures is obtained.In addition, patients are asked to consent to future analyses of the collected data. Withdrawal from the trial at any time for any reason does not hold any form of consequences whatsoever. Each participating centre has provided access to an independent physician who may offer additional trial information or advice if needed.
: All authors have given consent for publication. The trial protocol does not contain any individual patient data.
: The authors declare that they have no competing interests.