Abstract
BackgroundNumerous 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.MethodsPatients undergoing radical prostatectomy as initial treatment for prostate cancer were randomized in a factorial design to involvement of the fascia during placement of the anastomotic sutures, urethral irrigation, both or neither. Endpoint data were obtained from routine clinical documentation. Accrual and compliance rates were monitored to determine the feasibility of the trial.ResultsFrom a total of 260 eligible patients, 154 (59%) consented; 56 patients declined to participate, 20 were not approached on recommendation of the treating surgeon, and 30 were not approached for logistical reasons. Although recording by surgeons of the procedure used was incomplete (~80%), compliance with randomization was excellent when it was recorded, with only 6% of procedures inconsistent with allocation. Outcomes data was received from 71% of patients at one year. This improved to 83% as the trial progressed.ConclusionsA clinically-integrated randomized trial was conducted at low cost, with excellent accrual, and acceptable compliance with treatment allocation and outcomes reporting. This demonstrates the feasibility of the methodology. Improved methods to ensure documentation of surgical procedures would be required before wider implementation.Trial registrationClinicalTrials.gov NCT00928850
Highlights
Numerous technical modifications to radical prostatectomy have been proposed
The study took place in the urology clinics of Memorial Sloan Kettering Cancer Center (MSKCC) in New York, NY from July 2009 to April 2010. Eligible patients were those scheduled for radical prostatectomy for the treatment of prostate cancer with one of the consenting surgeons at MSKCC
We have demonstrated the feasibility of a clinically-integrated randomized trial
Summary
Numerous technical modifications to radical prostatectomy have been proposed. Such modifications are likely to lead to only slight improvements in outcomes. 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. The ideal outcome of a RP is complete removal of the cancer with no sunsequent recurrence, minimal blood loss, no serious perioperative complications and complete recovery of erectile and urinary function. No surgeon achieves such results uniformly and it appears likely that results are highly sensitive to fine details of surgical technique. It has been reported that surgeons with a higher yearly caseload have better outcomes [1,2,3] and that there is greater than chance variation between surgeons even adjusting for volume [1,2,4]
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