Evaluating new surgical procedures

Abstract

Surgery has been slow to take up the challenge of British epidemiologist Archie Cochrane: to prevent the introduction of new therapeutic procedures until randomised trials have shown them to be more effective than existing treatments.1 For example, laparoscopic cholecystectomy was first performed in 1987 and became the standard treatment for symptomatic gall stones within about seven years. During this period no more than 10 trials comparing laparoscopic with conventional forms of cholecystectomy were published worldwide. Of three peer reviewed randomised trials comparing laparoscopic and minilaparotomy cholecystectomy published in Britain since 1992,2 3 4 only one randomised more than 100 patients,5 justified this with a calculation of sample size, and analysed the results by intention to treat.6 Many potential problems have been cited to explain the shortage of rigorous surgical trials.7 Some are practical--for example, recruiting patients may be difficult. This problem can be resolved …

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