Feasibility of randomized controlled trials in liver surgery using surgery-related mortality or morbidity as endpoint
| Autor: | R.M. van Dam, G. van Breukelen, M. Malagó, S. W. M. Olde Damink, M.A.J. van den Broek, Cornelis H. C. Dejong |
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| Přispěvatelé: | RS: CAPHRI School for Public Health and Primary Care, RS: NUTRIM - R2 - Gut-liver homeostasis, RS: FPN M&S I, Algemene Heelkunde, FHML Methodologie & Statistiek, Dean and Directors Office |
| Jazyk: | angličtina |
| Rok vydání: | 2009 |
| Předmět: |
Adult
Male medicine.medical_specialty Randomization Adolescent law.invention Young Adult Postoperative Complications Randomized controlled trial law Epidemiology medicine Clinical endpoint Hepatectomy Humans Multicenter Studies as Topic Child Aged Randomized Controlled Trials as Topic business.industry Surrogate endpoint Mortality rate Liver Neoplasms Infant Middle Aged Surgery Clinical trial Sample size determination Child Preschool Feasibility Studies Female business |
| Zdroj: | British Journal of Surgery, 96(9), 1005-1014. Wiley |
| ISSN: | 0007-1323 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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