Randomized clinical trial of open versus laparoscopic left lateral hepatic sectionectomy within an enhanced recovery after surgery programme (ORANGE II study)

E. M. Wong-Lun-Hing; R. M. van Dam; the ORANGE II Collaborative Group; G. J.P. van Breukelen; P. J. Tanis; F. Ratti; R. van Hillegersberg; G. D. Slooter; J. H.W. de Wilt; M. S.L. Liem; M. T. de Boer; J. M. Klaase; U. P. Neumann; L. A. Aldrighetti; C. H.C. Dejong; T. Terkivatan; C. Verhoef; R. J. Porte; J. W. Haverman; O. R. Busch; M. A. Boermeester; M. G. Besselink; I. Q. Molenaar; I. H.M. Borel Rinkes; K. Bosscha; J. R. van der Vorst; J. W.D. de Waard; M. F. Gerhards; G. A. Patijn; M. Schmeding; J. N. Primrose; M. Abu Hilal; I. Dagher; A. Laurent; B. Topal; B. Edwin; K. Lassen; E. B. van Duyn; A. W. Ambergen; S. W. Olde Damink; M. H. Bemelmans

doi:10.1002/bjs.10438

Randomized clinical trial of open versus laparoscopic left lateral hepatic sectionectomy within an enhanced recovery after surgery programme (ORANGE II study)

E. M. Wong-Lun-Hing, R. M. van Dam^*, the ORANGE II Collaborative Group, G. J.P. van Breukelen, P. J. Tanis, F. Ratti, R. van Hillegersberg, G. D. Slooter, J. H.W. de Wilt, M. S.L. Liem, M. T. de Boer, J. M. Klaase, U. P. Neumann, L. A. Aldrighetti, C. H.C. Dejong, T. Terkivatan, C. Verhoef, R. J. Porte, J. W. Haverman, O. R. BuschM. A. Boermeester, M. G. Besselink, I. Q. Molenaar, I. H.M. Borel Rinkes, K. Bosscha, J. R. van der Vorst, J. W.D. de Waard, M. F. Gerhards, G. A. Patijn, M. Schmeding, J. N. Primrose, M. Abu Hilal, I. Dagher, A. Laurent, B. Topal, B. Edwin, K. Lassen, E. B. van Duyn, A. W. Ambergen, S. W. Olde Damink, M. H. Bemelmans

^*Corresponding author for this work

Surgery

Research output: Contribution to journal › Article › Academic › peer-review

91 Citations (Scopus)

Abstract

Background: Laparoscopic left lateral sectionectomy (LLLS) has been associated with shorter hospital stay and reduced overall morbidity compared with open left lateral sectionectomy (OLLS). Strong evidence has not, however, been provided. Methods: In this multicentre double-blind RCT, patients (aged 18–80 years with a BMI of 18–35 kg/m² and ASA fitness grade of III or below) requiring left lateral sectionectomy (LLS) were assigned randomly to OLLS or LLLS within an enhanced recovery after surgery (ERAS) programme. All randomized patients, ward physicians and nurses were blinded to the procedure undertaken. A parallel prospective registry (open non-randomized (ONR) versus laparoscopic non-randomized (LNR)) was used to monitor patients who were not enrolled for randomization because of doctor or patient preference. The primary endpoint was time to functional recovery. Secondary endpoints were length of hospital stay (LOS), readmission rate, overall morbidity, composite endpoint of liver surgery-specific morbidity, mortality, and reasons for delay in discharge after functional recovery. Results: Between January 2010 and July 2014, patients were recruited at ten centres. Of these, 24 patients were randomized at eight centres, and 67 patients from eight centres were included in the prospective registry. Owing to slow accrual, the trial was stopped on the advice of an independent Data and Safety Monitoring Board in the Netherlands. No significant difference in median (i.q.r.) time to functional recovery was observed between laparoscopic and open surgery in the randomized or non-randomized groups: 3 (3–5) days for OLLS versus 3 (3–3) days for LLLS; and 3 (3–3) days for ONR versus 3 (3–4) days for LNR. There were no significant differences with regard to LOS, morbidity, reoperation, readmission and mortality rates. Conclusion: This RCT comparing open and laparoscopic LLS in an ERAS setting was not able to reach a conclusion on time to functional recovery, because it was stopped prematurely owing to slow accrual. Registration number: NCT00874224 (https://www.clinicaltrials.gov).

Original language	English
Pages (from-to)	525-535
Number of pages	11
Journal	British Journal of Surgery
Volume	104
Issue number	5
DOIs	https://doi.org/10.1002/bjs.10438
Publication status	Published - Apr 2017

Bibliographical note

Funding Information:
The authors acknowledge the HPB surgical departments of Maastricht University Medical Centre and University Hospital Aachen, and the Dutch Liver Surgery Group for their support. They also express their gratitude to J. N. Primrose for his continuing involvement in, and constructive feedback to, the ORANGE II study. The authors thank all patients for their participation, and local clinical personnel and research staff involved in recruitment and data collection. In addition, they thank DSMB members (M. A. Boermeester, I. H. M. Borel Rinkes and A. W. Ambergen) for their time, expert input and advice. The ORANGE II trial was funded predominantly by the Profiling Fund of Maastricht University Medical Centre, Maastricht, The Netherlands (number PF 298). The trial was also funded by the participating centres of the ORANGE II study group and supported by an unrestricted grant from Medtronic, Dublin, Ireland. Medtronic and other funders had no influence on the design of the trial, no access to trial data, and no influence on the communication of trial results. Disclosure: The authors declare no conflict of interest.

Publisher Copyright:
© 2017 BJS Society Ltd Published by John Wiley & Sons Ltd

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10.1002/bjs.10438

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Wong-Lun-Hing, E. M., van Dam, R. M., the ORANGE II Collaborative Group, van Breukelen, G. J. P., Tanis, P. J., Ratti, F., van Hillegersberg, R., Slooter, G. D., de Wilt, J. H. W., Liem, M. S. L., de Boer, M. T., Klaase, J. M., Neumann, U. P., Aldrighetti, L. A., Dejong, C. H. C., Terkivatan, T., Verhoef, C., Porte, R. J., Haverman, J. W., ... Bemelmans, M. H. (2017). Randomized clinical trial of open versus laparoscopic left lateral hepatic sectionectomy within an enhanced recovery after surgery programme (ORANGE II study). British Journal of Surgery, 104(5), 525-535. https://doi.org/10.1002/bjs.10438

@article{2018f384263045bda62019aa92d70af4,

title = "Randomized clinical trial of open versus laparoscopic left lateral hepatic sectionectomy within an enhanced recovery after surgery programme (ORANGE II study)",

abstract = "Background: Laparoscopic left lateral sectionectomy (LLLS) has been associated with shorter hospital stay and reduced overall morbidity compared with open left lateral sectionectomy (OLLS). Strong evidence has not, however, been provided. Methods: In this multicentre double-blind RCT, patients (aged 18–80 years with a BMI of 18–35 kg/m2 and ASA fitness grade of III or below) requiring left lateral sectionectomy (LLS) were assigned randomly to OLLS or LLLS within an enhanced recovery after surgery (ERAS) programme. All randomized patients, ward physicians and nurses were blinded to the procedure undertaken. A parallel prospective registry (open non-randomized (ONR) versus laparoscopic non-randomized (LNR)) was used to monitor patients who were not enrolled for randomization because of doctor or patient preference. The primary endpoint was time to functional recovery. Secondary endpoints were length of hospital stay (LOS), readmission rate, overall morbidity, composite endpoint of liver surgery-specific morbidity, mortality, and reasons for delay in discharge after functional recovery. Results: Between January 2010 and July 2014, patients were recruited at ten centres. Of these, 24 patients were randomized at eight centres, and 67 patients from eight centres were included in the prospective registry. Owing to slow accrual, the trial was stopped on the advice of an independent Data and Safety Monitoring Board in the Netherlands. No significant difference in median (i.q.r.) time to functional recovery was observed between laparoscopic and open surgery in the randomized or non-randomized groups: 3 (3–5) days for OLLS versus 3 (3–3) days for LLLS; and 3 (3–3) days for ONR versus 3 (3–4) days for LNR. There were no significant differences with regard to LOS, morbidity, reoperation, readmission and mortality rates. Conclusion: This RCT comparing open and laparoscopic LLS in an ERAS setting was not able to reach a conclusion on time to functional recovery, because it was stopped prematurely owing to slow accrual. Registration number: NCT00874224 (https://www.clinicaltrials.gov).",

author = "Wong-Lun-Hing, {E. M.} and {van Dam}, {R. M.} and {the ORANGE II Collaborative Group} and {van Breukelen}, {G. J.P.} and Tanis, {P. J.} and F. Ratti and {van Hillegersberg}, R. and Slooter, {G. D.} and {de Wilt}, {J. H.W.} and Liem, {M. S.L.} and {de Boer}, {M. T.} and Klaase, {J. M.} and Neumann, {U. P.} and Aldrighetti, {L. A.} and Dejong, {C. H.C.} and T. Terkivatan and C. Verhoef and Porte, {R. J.} and Haverman, {J. W.} and Busch, {O. R.} and Boermeester, {M. A.} and Besselink, {M. G.} and Molenaar, {I. Q.} and {Borel Rinkes}, {I. H.M.} and K. Bosscha and {van der Vorst}, {J. R.} and {de Waard}, {J. W.D.} and Gerhards, {M. F.} and Patijn, {G. A.} and M. Schmeding and Primrose, {J. N.} and {Abu Hilal}, M. and I. Dagher and A. Laurent and B. Topal and B. Edwin and K. Lassen and {van Duyn}, {E. B.} and Ambergen, {A. W.} and {Olde Damink}, {S. W.} and Bemelmans, {M. H.}",

note = "Funding Information: The authors acknowledge the HPB surgical departments of Maastricht University Medical Centre and University Hospital Aachen, and the Dutch Liver Surgery Group for their support. They also express their gratitude to J. N. Primrose for his continuing involvement in, and constructive feedback to, the ORANGE II study. The authors thank all patients for their participation, and local clinical personnel and research staff involved in recruitment and data collection. In addition, they thank DSMB members (M. A. Boermeester, I. H. M. Borel Rinkes and A. W. Ambergen) for their time, expert input and advice. The ORANGE II trial was funded predominantly by the Profiling Fund of Maastricht University Medical Centre, Maastricht, The Netherlands (number PF 298). The trial was also funded by the participating centres of the ORANGE II study group and supported by an unrestricted grant from Medtronic, Dublin, Ireland. Medtronic and other funders had no influence on the design of the trial, no access to trial data, and no influence on the communication of trial results. Disclosure: The authors declare no conflict of interest. Publisher Copyright: {\textcopyright} 2017 BJS Society Ltd Published by John Wiley & Sons Ltd",

year = "2017",

month = apr,

doi = "10.1002/bjs.10438",

language = "English",

volume = "104",

pages = "525--535",

journal = "British Journal of Surgery",

issn = "0007-1323",

publisher = "John Wiley & Sons Ltd.",

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}

Wong-Lun-Hing, EM, van Dam, RM, the ORANGE II Collaborative Group, van Breukelen, GJP, Tanis, PJ, Ratti, F, van Hillegersberg, R, Slooter, GD, de Wilt, JHW, Liem, MSL, de Boer, MT, Klaase, JM, Neumann, UP, Aldrighetti, LA, Dejong, CHC, Terkivatan, T , Verhoef, C , Porte, RJ, Haverman, JW, Busch, OR, Boermeester, MA, Besselink, MG, Molenaar, IQ, Borel Rinkes, IHM, Bosscha, K, van der Vorst, JR, de Waard, JWD, Gerhards, MF, Patijn, GA, Schmeding, M, Primrose, JN, Abu Hilal, M, Dagher, I, Laurent, A, Topal, B, Edwin, B, Lassen, K, van Duyn, EB, Ambergen, AW, Olde Damink, SW & Bemelmans, MH 2017, 'Randomized clinical trial of open versus laparoscopic left lateral hepatic sectionectomy within an enhanced recovery after surgery programme (ORANGE II study)', British Journal of Surgery, vol. 104, no. 5, pp. 525-535. https://doi.org/10.1002/bjs.10438

Randomized clinical trial of open versus laparoscopic left lateral hepatic sectionectomy within an enhanced recovery after surgery programme (ORANGE II study). / Wong-Lun-Hing, E. M.; van Dam, R. M.; the ORANGE II Collaborative Group et al.
In: British Journal of Surgery, Vol. 104, No. 5, 04.2017, p. 525-535.

Research output: Contribution to journal › Article › Academic › peer-review

TY - JOUR

T1 - Randomized clinical trial of open versus laparoscopic left lateral hepatic sectionectomy within an enhanced recovery after surgery programme (ORANGE II study)

AU - Wong-Lun-Hing, E. M.

AU - van Dam, R. M.

AU - the ORANGE II Collaborative Group

AU - van Breukelen, G. J.P.

AU - Tanis, P. J.

AU - Ratti, F.

AU - van Hillegersberg, R.

AU - Slooter, G. D.

AU - de Wilt, J. H.W.

AU - Liem, M. S.L.

AU - de Boer, M. T.

AU - Klaase, J. M.

AU - Neumann, U. P.

AU - Aldrighetti, L. A.

AU - Dejong, C. H.C.

AU - Terkivatan, T.

AU - Verhoef, C.

AU - Porte, R. J.

AU - Haverman, J. W.

AU - Busch, O. R.

AU - Boermeester, M. A.

AU - Besselink, M. G.

AU - Molenaar, I. Q.

AU - Borel Rinkes, I. H.M.

AU - Bosscha, K.

AU - van der Vorst, J. R.

AU - de Waard, J. W.D.

AU - Gerhards, M. F.

AU - Patijn, G. A.

AU - Schmeding, M.

AU - Primrose, J. N.

AU - Abu Hilal, M.

AU - Dagher, I.

AU - Laurent, A.

AU - Topal, B.

AU - Edwin, B.

AU - Lassen, K.

AU - van Duyn, E. B.

AU - Ambergen, A. W.

AU - Olde Damink, S. W.

AU - Bemelmans, M. H.

N1 - Funding Information: The authors acknowledge the HPB surgical departments of Maastricht University Medical Centre and University Hospital Aachen, and the Dutch Liver Surgery Group for their support. They also express their gratitude to J. N. Primrose for his continuing involvement in, and constructive feedback to, the ORANGE II study. The authors thank all patients for their participation, and local clinical personnel and research staff involved in recruitment and data collection. In addition, they thank DSMB members (M. A. Boermeester, I. H. M. Borel Rinkes and A. W. Ambergen) for their time, expert input and advice. The ORANGE II trial was funded predominantly by the Profiling Fund of Maastricht University Medical Centre, Maastricht, The Netherlands (number PF 298). The trial was also funded by the participating centres of the ORANGE II study group and supported by an unrestricted grant from Medtronic, Dublin, Ireland. Medtronic and other funders had no influence on the design of the trial, no access to trial data, and no influence on the communication of trial results. Disclosure: The authors declare no conflict of interest. Publisher Copyright: © 2017 BJS Society Ltd Published by John Wiley & Sons Ltd

PY - 2017/4

Y1 - 2017/4

N2 - Background: Laparoscopic left lateral sectionectomy (LLLS) has been associated with shorter hospital stay and reduced overall morbidity compared with open left lateral sectionectomy (OLLS). Strong evidence has not, however, been provided. Methods: In this multicentre double-blind RCT, patients (aged 18–80 years with a BMI of 18–35 kg/m2 and ASA fitness grade of III or below) requiring left lateral sectionectomy (LLS) were assigned randomly to OLLS or LLLS within an enhanced recovery after surgery (ERAS) programme. All randomized patients, ward physicians and nurses were blinded to the procedure undertaken. A parallel prospective registry (open non-randomized (ONR) versus laparoscopic non-randomized (LNR)) was used to monitor patients who were not enrolled for randomization because of doctor or patient preference. The primary endpoint was time to functional recovery. Secondary endpoints were length of hospital stay (LOS), readmission rate, overall morbidity, composite endpoint of liver surgery-specific morbidity, mortality, and reasons for delay in discharge after functional recovery. Results: Between January 2010 and July 2014, patients were recruited at ten centres. Of these, 24 patients were randomized at eight centres, and 67 patients from eight centres were included in the prospective registry. Owing to slow accrual, the trial was stopped on the advice of an independent Data and Safety Monitoring Board in the Netherlands. No significant difference in median (i.q.r.) time to functional recovery was observed between laparoscopic and open surgery in the randomized or non-randomized groups: 3 (3–5) days for OLLS versus 3 (3–3) days for LLLS; and 3 (3–3) days for ONR versus 3 (3–4) days for LNR. There were no significant differences with regard to LOS, morbidity, reoperation, readmission and mortality rates. Conclusion: This RCT comparing open and laparoscopic LLS in an ERAS setting was not able to reach a conclusion on time to functional recovery, because it was stopped prematurely owing to slow accrual. Registration number: NCT00874224 (https://www.clinicaltrials.gov).

AB - Background: Laparoscopic left lateral sectionectomy (LLLS) has been associated with shorter hospital stay and reduced overall morbidity compared with open left lateral sectionectomy (OLLS). Strong evidence has not, however, been provided. Methods: In this multicentre double-blind RCT, patients (aged 18–80 years with a BMI of 18–35 kg/m2 and ASA fitness grade of III or below) requiring left lateral sectionectomy (LLS) were assigned randomly to OLLS or LLLS within an enhanced recovery after surgery (ERAS) programme. All randomized patients, ward physicians and nurses were blinded to the procedure undertaken. A parallel prospective registry (open non-randomized (ONR) versus laparoscopic non-randomized (LNR)) was used to monitor patients who were not enrolled for randomization because of doctor or patient preference. The primary endpoint was time to functional recovery. Secondary endpoints were length of hospital stay (LOS), readmission rate, overall morbidity, composite endpoint of liver surgery-specific morbidity, mortality, and reasons for delay in discharge after functional recovery. Results: Between January 2010 and July 2014, patients were recruited at ten centres. Of these, 24 patients were randomized at eight centres, and 67 patients from eight centres were included in the prospective registry. Owing to slow accrual, the trial was stopped on the advice of an independent Data and Safety Monitoring Board in the Netherlands. No significant difference in median (i.q.r.) time to functional recovery was observed between laparoscopic and open surgery in the randomized or non-randomized groups: 3 (3–5) days for OLLS versus 3 (3–3) days for LLLS; and 3 (3–3) days for ONR versus 3 (3–4) days for LNR. There were no significant differences with regard to LOS, morbidity, reoperation, readmission and mortality rates. Conclusion: This RCT comparing open and laparoscopic LLS in an ERAS setting was not able to reach a conclusion on time to functional recovery, because it was stopped prematurely owing to slow accrual. Registration number: NCT00874224 (https://www.clinicaltrials.gov).

UR - http://www.scopus.com/inward/record.url?scp=85011277186&partnerID=8YFLogxK

U2 - 10.1002/bjs.10438

DO - 10.1002/bjs.10438

M3 - Article

C2 - 28138958

AN - SCOPUS:85011277186

SN - 0007-1323

VL - 104

SP - 525

EP - 535

JO - British Journal of Surgery

JF - British Journal of Surgery

IS - 5

ER -

Randomized clinical trial of open versus laparoscopic left lateral hepatic sectionectomy within an enhanced recovery after surgery programme (ORANGE II study)

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