Laparoscopic versus open resections in the posterosuperior liver segments within an enhanced recovery programme (ORANGE Segments): study protocol for a multicentre randomised controlled trial.
Enhanced recovery
Laparoscopy
Liver surgery
Posterosuperior segments
Randomised controlled trial
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
09 Mar 2022
09 Mar 2022
Historique:
received:
18
05
2021
accepted:
15
02
2022
entrez:
10
3
2022
pubmed:
11
3
2022
medline:
12
3
2022
Statut:
epublish
Résumé
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. 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. 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. ClinicalTrials.gov NCT03270917 . Registered on September 1, 2017. Before start of inclusion. version 12, May 9, 2017.
Sections du résumé
BACKGROUND
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
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
CONCLUSIONS
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
BACKGROUND
ClinicalTrials.gov NCT03270917 . Registered on September 1, 2017. Before start of inclusion.
PROTOCOL VERSION
METHODS
version 12, May 9, 2017.
Identifiants
pubmed: 35264216
doi: 10.1186/s13063-022-06112-3
pii: 10.1186/s13063-022-06112-3
pmc: PMC8908665
doi:
Banques de données
ClinicalTrials.gov
['NCT03270917']
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
206Subventions
Organisme : Ethicon Endo-Surgery
ID : 1210958
Organisme : Cancer Research UK
ID : C317/A16248
Pays : United Kingdom
Informations de copyright
© 2022. The Author(s).
Références
Br J Surg. 2018 Aug;105(9):1182-1191
pubmed: 29737513
Cancer Treat Res. 1995;75:1-27
pubmed: 7640159
Surgery. 1992 May;111(5):518-26
pubmed: 1598671
HPB (Oxford). 2014 Aug;16(8):699-706
pubmed: 24661306
Ann Surg Oncol. 2011 Apr;18(4):1096-103
pubmed: 21042942
J Am Coll Surg. 2015 Aug;221(2):265-72
pubmed: 25899733
World J Surg. 2014 Dec;38(12):3169-74
pubmed: 25159116
J Laparoendosc Adv Surg Tech A. 2016 Jun;26(6):457-64
pubmed: 27120254
Surg Endosc. 2018 Mar;32(3):1478-1485
pubmed: 28916866
Ann Surg. 2009 Aug;250(2):177-86
pubmed: 19638919
BMJ. 2010 Mar 23;340:c332
pubmed: 20332509
Eur J Surg Oncol. 2013 Jun;39(6):542-7
pubmed: 23562361
Surg Endosc. 2007 Aug;21(8):1301-7
pubmed: 17522936
J Am Coll Surg. 2010 Mar;210(3):286-98
pubmed: 20193891
BMJ. 2014 Dec 09;349:g6870
pubmed: 25491195
J Hepatobiliary Pancreat Sci. 2014 Oct;21(10):745-53
pubmed: 25242563
Ann Surg. 2017 Jun;265(6):1192-1200
pubmed: 28151797
Br J Surg. 2013 Jul;100(8):1015-24
pubmed: 23696477
World J Surg. 2014 Dec;38(12):3175-80
pubmed: 25138071
HPB (Oxford). 2018 Mar;20(3):231-236
pubmed: 28969960
Ann Surg Oncol. 2015 Apr;22(4):1288-93
pubmed: 25256130
Br J Surg. 2017 May;104(6):751-759
pubmed: 28194774
Medicine (Baltimore). 2016 Oct;95(43):e5138
pubmed: 27787369
Br J Surg. 2008 Aug;95(8):969-75
pubmed: 18618897
Ann Surg Oncol. 2019 Dec;26(13):4576-4586
pubmed: 31605335
Br J Surg. 2009 Sep;96(9):1005-14
pubmed: 19672937
J Am Coll Surg. 2017 Nov;225(5):639-649
pubmed: 28838869
BMJ. 2013 Jan 08;346:e7586
pubmed: 23303884
Ann Surg. 2019 Nov;270(5):727-734
pubmed: 31634176
Surg Endosc. 2018 Feb;32(2):872-878
pubmed: 28730274
Ann Surg. 2014 Nov;260(5):757-62; discussion 762-3
pubmed: 25379846
Ann Surg. 2016 Mar;263(3):529-37
pubmed: 25563884
Ann Surg. 2015 Apr;261(4):619-29
pubmed: 25742461
World J Surg. 2016 Oct;40(10):2425-40
pubmed: 27549599
Trials. 2012 May 06;13:54
pubmed: 22559239
Surg Endosc. 1998 Nov;12(11):1334-40
pubmed: 9788857
Ann Surg. 2009 Nov;250(5):825-30
pubmed: 19916210
Ann Surg. 2018 Jul;268(1):11-18
pubmed: 29064908
Surg Endosc. 2011 Dec;25(12):3881-9
pubmed: 21735326
Updates Surg. 2020 Sep;72(3):649-657
pubmed: 32418169
Br J Surg. 2017 Apr;104(5):525-535
pubmed: 28138958
Ann Surg. 2018 Jan;267(1):13-17
pubmed: 28187043
Control Clin Trials. 2002 Dec;23(6):662-74
pubmed: 12505244
Hepatogastroenterology. 2014 Jan-Feb;61(129):168-72
pubmed: 24895815
J Gastrointest Surg. 2017 Jun;21(6):1076-1085
pubmed: 28364212
Biometrics. 1975 Mar;31(1):103-15
pubmed: 1100130
Br J Surg. 2009 Mar;96(3):291-8
pubmed: 19224519
Clin Transl Oncol. 2015 Sep;17(9):694-701
pubmed: 25997686
Surg Endosc. 2015 Oct;29(10):2994-3001
pubmed: 25899815
Surg Endosc. 2015 Nov;29(11):3190-5
pubmed: 25582963
Surg Endosc. 2018 Apr;32(4):2012-2019
pubmed: 29075968
Ann Surg. 2019 Feb;269(2):221-228
pubmed: 30080729
Br J Surg. 2006 Aug;93(8):1007-14
pubmed: 16739102
J Hepatol. 2001 Sep;35(3):421-30
pubmed: 11592607
Ann Surg. 2009 Nov;250(5):772-82
pubmed: 19801926
Surg Oncol. 2017 Dec;26(4):345-346
pubmed: 29113650
Health Econ. 2006 Oct;15(10):1121-32
pubmed: 16786549
J Clin Oncol. 2011 Aug 10;29(23):3140-5
pubmed: 21730269
Surgery. 2015 Jul;158(1):135-41
pubmed: 25799467
Ann Surg. 2021 Apr 1;273(4):785-791
pubmed: 31460879
Ann Surg. 2020 Aug;272(2):253-265
pubmed: 32675538
Am J Public Health. 1994 Aug;84(8):1270-3
pubmed: 8059884