Feasibility study of a clinically-integrated randomized trial of modifications to radical prostatectomy.

ABSTRACT:

Background

Numerous technical modifications to radical prostatectomy have been proposed. Such modifications are likely to lead to only slight improvements in outcomes. Although small differences would be worthwhile, an appropriately powered randomized trial would need to be very large, and thus of doubtful feasibility given the expense, complexity and regulatory burden of contemporary clinical trials. We have proposed a novel methodology, the clinically-integrated randomized trial, which dramatically streamlines trial procedures in order to reduce the marginal cost of an additional patient towards zero. We aimed to determine the feasibility of implementing such a trial for radical prostatectomy.

Methods

Patients undergoing radical prostatectomy as initial treatment for prost

SUBMITTER: Vickers AJ 

PROVIDER: S-EPMC3298715 | biostudies-literature | 2012 Feb

REPOSITORIES: biostudies-literature