TY - JOUR
T1 - Laparoscopic versus open resections in the posterosuperior liver segments within an enhanced recovery programme (ORANGE Segments)
T2 - study protocol for a multicentre randomised controlled trial
AU - Kuemmerli, Christoph
AU - Fichtinger, Robert S.
AU - Moekotte, Alma
AU - Aldrighetti, Luca A.
AU - Aroori, Somaiah
AU - Besselink, Marc G. H.
AU - D’Hondt, Mathieu
AU - Díaz-Nieto, Rafael
AU - Edwin, Bjørn
AU - Efanov, Mikhail
AU - Ettorre, Giuseppe M.
AU - Menon, Krishna V.
AU - Sheen, Aali J.
AU - Soonawalla, Zahir
AU - Sutcliffe, Robert
AU - Troisi, Roberto I.
AU - White, Steven A.
AU - Brandts, Lloyd
AU - van Breukelen, Gerard J. P.
AU - Sijberden, Jasper
AU - Pugh, Siân A.
AU - Eminton, Zina
AU - Primrose, John N.
AU - on behalf of the ORANGE trials collaborative
AU - van Dam, Ronald
AU - Hilal, Mohammed Abu
N1 - 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).
PY - 2022/12/1
Y1 - 2022/12/1
N2 - 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.
AB - 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.
KW - Enhanced recovery
KW - Laparoscopy
KW - Liver surgery
KW - Posterosuperior segments
KW - Randomised controlled trial
UR - http://www.scopus.com/inward/record.url?scp=85126081023&partnerID=8YFLogxK
U2 - https://doi.org/10.1186/s13063-022-06112-3
DO - https://doi.org/10.1186/s13063-022-06112-3
M3 - Article
C2 - 35264216
SN - 1745-6215
VL - 23
JO - Trials
JF - Trials
IS - 1
M1 - 206
ER -