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

Vickers AJ, Bennette C, Touijer K, Coleman J, Laudone V, Carver B, Eastham JA, Scardino PT - Trials (2012)

Bottom Line: Such modifications are likely to lead to only slight improvements in outcomes.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.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Epidemiology and Biostatistics, Memorial Sloan-Kettering Cancer Center, New York, NY 11215, USA. vickersa@mskcc.org

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 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.

Results: From 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.

Conclusions: A 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 registration: ClinicalTrials.gov NCT00928850.

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Related in: MedlinePlus

Summary of patient consent and randomization.
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Figure 1: Summary of patient consent and randomization.

Mentions: The trial was stopped shortly before achieving accrual goals when the Urology Service at Memorial Sloan-Kettering Cancer Center placed a temporary moratorium on all clinical trial consents due to staffing changes. Out of a total of 260 eligible patients, 154 (59%; 95% C.I. 53%, 65%) consented. Of the remainder, 56 patients declined to participate and 20 were not approached on recommendation of the treating surgeon. Thirty patients were not approached for logistical reasons, such as staff availability or patient time constraints (Figure 1).


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

Vickers AJ, Bennette C, Touijer K, Coleman J, Laudone V, Carver B, Eastham JA, Scardino PT - Trials (2012)

Summary of patient consent and randomization.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC3298715&req=5

Figure 1: Summary of patient consent and randomization.
Mentions: The trial was stopped shortly before achieving accrual goals when the Urology Service at Memorial Sloan-Kettering Cancer Center placed a temporary moratorium on all clinical trial consents due to staffing changes. Out of a total of 260 eligible patients, 154 (59%; 95% C.I. 53%, 65%) consented. Of the remainder, 56 patients declined to participate and 20 were not approached on recommendation of the treating surgeon. Thirty patients were not approached for logistical reasons, such as staff availability or patient time constraints (Figure 1).

Bottom Line: Such modifications are likely to lead to only slight improvements in outcomes.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.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Epidemiology and Biostatistics, Memorial Sloan-Kettering Cancer Center, New York, NY 11215, USA. vickersa@mskcc.org

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 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.

Results: From 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.

Conclusions: A 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 registration: ClinicalTrials.gov NCT00928850.

Show MeSH
Related in: MedlinePlus