Robotic versus laparoscopic hepatectomy for liver malignancies (ROC'N'ROLL): a single-centre, randomised, controlled, single-blinded clinical trial.

DaVinci® Liver resection Minimally invasive hepatectomy Randomized controlled trial Robot-assisted

Journal

The Lancet regional health. Europe
ISSN: 2666-7762
Titre abrégé: Lancet Reg Health Eur
Pays: England
ID NLM: 101777707

Informations de publication

Date de publication:
Aug 2024
Historique:
received: 09 03 2024
revised: 01 06 2024
accepted: 05 06 2024
medline: 31 8 2024
pubmed: 31 8 2024
entrez: 30 8 2024
Statut: epublish

Résumé

Robotic hepatectomy (RH) has been increasingly adopted for the treatment of liver malignancies despite lacking evidence from randomised trials. We aimed to determine the effect of RH compared to laparoscopic hepatectomy (LH) on quality of life in patients undergoing minimally invasive hepatectomy for liver malignancies. This single-blinded, randomised trial was conducted at a tertiary care academic centre (DRKS00027531). Patients with resectable liver malignancies were assessed for eligibility and randomly assigned to either RH or LH with stratification by type of malignancy and difficulty of resection. Patients were blinded to the treatment allocation. The primary outcome was the mean quality of life within 90 days after surgery, measured with the role functioning scale of the European Organisation for Research and Treatment of Cancer QLQ-C30 questionnaire. Secondary outcomes included operating time, morbidity, blood loss, conversion rate, postoperative recovery, and resection margin status. Between February 21, 2022, and Sep 18, 2023, 80 patients (RH: n = 41, LH: n = 39) were included and analysed on an intention-to-treat basis. Role functioning scores did not differ between RH and LH (mean [SD], 74.3 [23.3] versus 79.6 [22.3]; mean difference -5.3, 95% CI -15.6 to 5.1, p = 0.547). The comprehensive complication index was not significantly different between the study groups (8.9 [23.1] versus 15.5 [23.9], p = 0.137). There were no differences in other perioperative outcomes. RH yielded similar outcomes in quality of life and can be considered a safe alternative to LH. None.

Sections du résumé

Background UNASSIGNED
Robotic hepatectomy (RH) has been increasingly adopted for the treatment of liver malignancies despite lacking evidence from randomised trials. We aimed to determine the effect of RH compared to laparoscopic hepatectomy (LH) on quality of life in patients undergoing minimally invasive hepatectomy for liver malignancies.
Methods UNASSIGNED
This single-blinded, randomised trial was conducted at a tertiary care academic centre (DRKS00027531). Patients with resectable liver malignancies were assessed for eligibility and randomly assigned to either RH or LH with stratification by type of malignancy and difficulty of resection. Patients were blinded to the treatment allocation. The primary outcome was the mean quality of life within 90 days after surgery, measured with the role functioning scale of the European Organisation for Research and Treatment of Cancer QLQ-C30 questionnaire. Secondary outcomes included operating time, morbidity, blood loss, conversion rate, postoperative recovery, and resection margin status.
Findings UNASSIGNED
Between February 21, 2022, and Sep 18, 2023, 80 patients (RH: n = 41, LH: n = 39) were included and analysed on an intention-to-treat basis. Role functioning scores did not differ between RH and LH (mean [SD], 74.3 [23.3] versus 79.6 [22.3]; mean difference -5.3, 95% CI -15.6 to 5.1, p = 0.547). The comprehensive complication index was not significantly different between the study groups (8.9 [23.1] versus 15.5 [23.9], p = 0.137). There were no differences in other perioperative outcomes.
Interpretation UNASSIGNED
RH yielded similar outcomes in quality of life and can be considered a safe alternative to LH.
Funding UNASSIGNED
None.

Identifiants

pubmed: 39210947
doi: 10.1016/j.lanepe.2024.100972
pii: S2666-7762(24)00139-X
pmc: PMC11360176
doi:

Types de publication

Journal Article

Langues

eng

Pagination

100972

Informations de copyright

© 2024 The Author(s).

Déclaration de conflit d'intérêts

None to be declared.

Références

J Gastrointest Surg. 2024 Jan;28(1):99-101
pubmed: 38353085
Br J Surg. 2019 Sep;106(10):1372-1380
pubmed: 31322735
Cancers (Basel). 2021 Sep 25;13(19):
pubmed: 34638285
Surg Endosc. 2024 Mar;38(3):1296-1305
pubmed: 38102396
Zentralbl Chir. 2023 Apr;148(2):129-132
pubmed: 36104087
Asian J Surg. 2023 Sep;46(9):3593-3600
pubmed: 37537065
BMC Med Res Methodol. 2018 Aug 28;18(1):87
pubmed: 30153796
J Gastrointest Surg. 2016 Sep;20(9):1608-17
pubmed: 27412321
World J Surg. 2020 Mar;44(3):887-895
pubmed: 31748885
Surgery. 2011 May;149(5):713-24
pubmed: 21236455
HPB (Oxford). 2020 Feb;22(2):177-186
pubmed: 32008917
Surgery. 2023 Feb;173(2):401-411
pubmed: 36424196
Lancet. 2017 Sep 9;390(10099):1027-1037
pubmed: 28901935
HPB (Oxford). 2021 Oct;23(10):1467-1481
pubmed: 33820689
JAMA Surg. 2021 Jan 1;156(1):31-40
pubmed: 33147332
Contemp Clin Trials. 2011 Mar;32(2):240-3
pubmed: 21070890
Br J Surg. 2021 Dec 1;108(12):1513-1520
pubmed: 34750608
Lancet Gastroenterol Hepatol. 2022 Nov;7(11):991-1004
pubmed: 36087608
Ann Surg Oncol. 2023 Aug;30(8):4783-4796
pubmed: 37202573
Surg Clin North Am. 2010 Aug;90(4):761-74
pubmed: 20637946
Br J Surg. 2024 Mar 2;111(3):
pubmed: 38525931
Surg Endosc. 2022 Dec;36(12):8935-8942
pubmed: 35668311
J Natl Cancer Inst. 1993 Mar 3;85(5):365-76
pubmed: 8433390
Br J Surg. 2018 Feb;105(3):237-243
pubmed: 29405277
J Laparoendosc Adv Surg Tech A. 2018 Mar;28(3):302-310
pubmed: 29172949
Clin Ther. 2016 Apr;38(4):756-8
pubmed: 27038639
Asian J Surg. 2018 Sep;41(5):401-416
pubmed: 28912048
Hepatobiliary Surg Nutr. 2016 Aug;5(4):281-9
pubmed: 27500140
Ann Surg. 2013 Jul;258(1):1-7
pubmed: 23728278
J Chin Med Assoc. 2023 Mar 1;86(3):282-288
pubmed: 36622784
Ann Surg Oncol. 2023 Mar;30(3):1331-1338
pubmed: 36350458
HPB (Oxford). 2020 Jul;22(7):987-995
pubmed: 31680010
Cancers (Basel). 2022 Jul 11;14(14):
pubmed: 35884421
Eur J Surg Oncol. 2023 Sep;49(9):106933
pubmed: 37211468
Ann Surg. 2022 Apr 1;275(4):646-653
pubmed: 34171870
Surg Endosc. 2022 Feb;36(2):889-895
pubmed: 33608766
Surg Endosc. 2021 Feb;35(2):524-535
pubmed: 32989544
Asian J Surg. 2019 Apr;42(4):543-550
pubmed: 30704965
Int J Surg. 2023 Dec 01;109(12):4333-4346
pubmed: 37720925
Surg Endosc. 2024 Jan;38(1):56-65
pubmed: 38017157
J Clin Epidemiol. 2020 Feb;118:1-8
pubmed: 31639445
Eur J Cancer. 2012 Jul;48(11):1713-21
pubmed: 22418017
Clin Epidemiol. 2015 Jan 16;7:91-106
pubmed: 25653557
Cancer. 2013 Feb 15;119(4):880-7
pubmed: 22930253
J Hepatobiliary Pancreat Sci. 2022 Jul;29(7):785-797
pubmed: 34856068
Arch Surg. 2003 Jul;138(7):777-84
pubmed: 12860761
Lancet Reg Health Eur. 2023 Jul 06;31:100673
pubmed: 37457332
Ann Surg. 2018 Feb;267(2):199-207
pubmed: 28657937
J Clin Oncol. 2012 Apr 20;30(12):1364-70
pubmed: 22430276
Int J Surg. 2017 Dec;48:281-285
pubmed: 29175019
Surg Endosc. 2020 May;34(5):2000-2006
pubmed: 31312961
Health Qual Life Outcomes. 2016 May 06;14:72
pubmed: 27150974
Qual Life Res. 2015 Jul;24(7):1669-75
pubmed: 25502092
J Surg Res. 2017 Sep;217:92-99
pubmed: 28641762
Am J Surg. 2013 Oct;206(4):443-50
pubmed: 23856086
Surg Endosc. 2019 Dec;33(12):3926-3936
pubmed: 30701365
JAMA Surg. 2021 Jan 1;156(1):22-29
pubmed: 33084881

Auteurs

Emrullah Birgin (E)

Department of General and Visceral Surgery, Ulm University Hospital, Ulm, Germany.
Department of Surgery, Universitätsmedizin Mannheim, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.

Marie Heibel (M)

Department of Surgery, Universitätsmedizin Mannheim, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.

Svetlana Hetjens (S)

Department of Medical Statistics and Biomathematics, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.

Erik Rasbach (E)

Department of Surgery, Universitätsmedizin Mannheim, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.

Christoph Reissfelder (C)

Department of Surgery, Universitätsmedizin Mannheim, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.

Patrick Téoule (P)

Department of Surgery, Universitätsmedizin Mannheim, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.

Nuh N Rahbari (NN)

Department of General and Visceral Surgery, Ulm University Hospital, Ulm, Germany.
Department of Surgery, Universitätsmedizin Mannheim, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.

Classifications MeSH