BACKGROUND: There is a shortage of randomized controlled trials (RCTs) on which to base guidelines in liver surgery. The feasibility of conducting an adequately powered RCT in liver surgery using the dichotomous endpoints surgery-related mortality or morbidity was examined. METHODS: Articles published between January 2002 and November 2007 with mortality or morbidity after liver surgery as primary endpoint were retrieved. Sample size calculations for a RCT aiming to show a relative reduction of these endpoints by 33, 50 or 66 per cent were performed. RESULTS: The mean operative mortality rate was 1.0 per cent and the total morbidity rate 28.9 per cent; mean rates of bile leakage and postresectional liver failure were 4.4 and 2.6 per cent respectively. The smallest numbers of patients needed in each arm of a RCT aiming to show a 33 per cent relative reduction were 15 614 for operative mortality, 412 for total morbidity, 3446 for bile leakage and 5924 for postresectional liver failure. CONCLUSION: The feasibility of conducting an adequately powered RCT in liver surgery using outcomes such as mortality or specific complications seems low. Conclusions of underpowered RCTs should be interpreted with caution. A liver surgery-specific composite endpoint may be a useful and clinically relevant solution to pursue. (c) 2009 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.
BACKGROUND: There is a shortage of randomized controlled trials (RCTs) on which to base guidelines in liver surgery. The feasibility of conducting an adequately powered RCT in liver surgery using the dichotomous endpoints surgery-related mortality or morbidity was examined. METHODS: Articles published between January 2002 and November 2007 with mortality or morbidity after liver surgery as primary endpoint were retrieved. Sample size calculations for a RCT aiming to show a relative reduction of these endpoints by 33, 50 or 66 per cent were performed. RESULTS: The mean operative mortality rate was 1.0 per cent and the total morbidity rate 28.9 per cent; mean rates of bile leakage and postresectional liver failure were 4.4 and 2.6 per cent respectively. The smallest numbers of patients needed in each arm of a RCT aiming to show a 33 per cent relative reduction were 15 614 for operative mortality, 412 for total morbidity, 3446 for bile leakage and 5924 for postresectional liver failure. CONCLUSION: The feasibility of conducting an adequately powered RCT in liver surgery using outcomes such as mortality or specific complications seems low. Conclusions of underpowered RCTs should be interpreted with caution. A liver surgery-specific composite endpoint may be a useful and clinically relevant solution to pursue. (c) 2009 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.
Authors: J R A Skipworth; S W M Olde Damink; C Imber; J Bridgewater; S P Pereira; M Malagó Journal: Aliment Pharmacol Ther Date: 2011-09-20 Impact factor: 8.171
Authors: Liliane Mpabanzi; Kim M C van Mierlo; Massimo Malagó; Cornelis H C Dejong; Dimitrios Lytras; Steven W M Olde Damink Journal: HPB (Oxford) Date: 2012-10-22 Impact factor: 3.647
Authors: Christoph Kuemmerli; Robert S Fichtinger; Alma Moekotte; Luca A Aldrighetti; Somaiah Aroori; Marc G H Besselink; Mathieu D'Hondt; Rafael Díaz-Nieto; Bjørn Edwin; Mikhail Efanov; Giuseppe M Ettorre; Krishna V Menon; Aali J Sheen; Zahir Soonawalla; Robert Sutcliffe; Roberto I Troisi; Steven A White; Lloyd Brandts; Gerard J P van Breukelen; Jasper Sijberden; Siân A Pugh; Zina Eminton; John N Primrose; Ronald van Dam; Mohammed Abu Hilal Journal: Trials Date: 2022-03-09 Impact factor: 2.279
Authors: Marielle M E Coolsen; Stefan H E M Clermonts; Ronald M van Dam; Bjorn Winkens; Massimo Malagó; Giuseppe K Fusai; Cornelis H C Dejong; Steven W M Olde Damink Journal: World J Surg Date: 2014-06 Impact factor: 3.352
Authors: Ronald M van Dam; Edgar M Wong-Lun-Hing; Gerard J P van Breukelen; Jan H M B Stoot; Joost R van der Vorst; Marc H A Bemelmans; Steven W M Olde Damink; Kristoffer Lassen; Cornelis H C Dejong Journal: Trials Date: 2012-05-06 Impact factor: 2.279
Authors: Lars Enochsson; My Blohm; Gabriel Sandblom; Eduard Jonas; Bengt Hallerbäck; Lars Lundell; Johanna Österberg Journal: BMJ Open Date: 2018-01-23 Impact factor: 2.692