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

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

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.

Hepatectomy/adverse effects, Humans, Laparoscopy/adverse effects, Length of Stay, Liver Neoplasms/surgery, Multicenter Studies as Topic, Quality of Life, Randomized Controlled Trials as Topic, Treatment Outcome
1745-6215
206
Kuemmerli, Christoph
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Fichtinger, Robert S
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Moekotte, Alma
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Aldrighetti, Luca A
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Aroori, Somaiah
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Besselink, Marc G H
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D'Hondt, Mathieu
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Díaz-Nieto, Rafael
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Edwin, Bjørn
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Efanov, Mikhail
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Ettorre, Giuseppe M
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Menon, Krishna V
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Sheen, Aali J
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Soonawalla, Zahir
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Sutcliffe, Robert
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Troisi, Roberto I
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White, Steven A
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Brandts, Lloyd
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van Breukelen, Gerard J P
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Sijberden, Jasper
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Pugh, Siân A
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Eminton, Zina
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Primrose, John N
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van Dam, Ronald
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Hilal, Mohammed Abu
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ORANGE trials collaborative
Kuemmerli, Christoph
85b9f630-6845-4b8a-bbd7-76ace58cebfb
Fichtinger, Robert S
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Moekotte, Alma
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Aldrighetti, Luca A
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Aroori, Somaiah
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Besselink, Marc G H
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D'Hondt, Mathieu
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Díaz-Nieto, Rafael
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Edwin, Bjørn
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Efanov, Mikhail
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Ettorre, Giuseppe M
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Menon, Krishna V
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Sheen, Aali J
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Soonawalla, Zahir
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Sutcliffe, Robert
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Troisi, Roberto I
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White, Steven A
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Brandts, Lloyd
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van Breukelen, Gerard J P
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Sijberden, Jasper
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Pugh, Siân A
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Eminton, Zina
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Primrose, John N
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van Dam, Ronald
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Hilal, Mohammed Abu
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ORANGE trials collaborative (2022) Laparoscopic versus open resections in the posterosuperior liver segments within an enhanced recovery programme (ORANGE Segments): study protocol for a multicentre randomised controlled trial. Trials, 23 (1), 206, [206]. (doi:10.1186/s13063-022-06112-3).

Record type: Article

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.

Text
s13063-022-06112-3 - Version of Record
Available under License Creative Commons Attribution.
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Accepted/In Press date: 15 February 2022
Published date: 9 March 2022
Additional Information: Funding Information: The ORANGE Segments - Trial is funded by the Ethicon (Johnson & Johnson) grant, reference number GOIIS200124; the Cancer Research United Kingdom Phase III Clinical Trial grant, reference number C317/A16248; and the Maastricht University Medical Center+. Publisher Copyright: © 2022, The Author(s). Copyright: Copyright 2022 Elsevier B.V., All rights reserved.
Keywords: Hepatectomy/adverse effects, Humans, Laparoscopy/adverse effects, Length of Stay, Liver Neoplasms/surgery, Multicenter Studies as Topic, Quality of Life, Randomized Controlled Trials as Topic, Treatment Outcome

Identifiers

Local EPrints ID: 456703
URI: http://eprints.soton.ac.uk/id/eprint/456703
ISSN: 1745-6215
PURE UUID: 5130ac97-9880-454a-ae9d-dcaf60483864
ORCID for Steven A White: ORCID iD orcid.org/0000-0002-2296-7082
ORCID for John N Primrose: ORCID iD orcid.org/0000-0002-2069-7605

Catalogue record

Date deposited: 09 May 2022 17:16
Last modified: 10 May 2022 01:34

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Contributors

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

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