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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, an...

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Autores principales: Vickers, Andrew J, Bennette, Caroline, Touijer, Karim, Coleman, Jonathan, Laudone, Vincent, Carver, Brett, Eastham, James A, Scardino, Peter T
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2012
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3298715/
https://www.ncbi.nlm.nih.gov/pubmed/22364367
http://dx.doi.org/10.1186/1745-6215-13-23
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author Vickers, Andrew J
Bennette, Caroline
Touijer, Karim
Coleman, Jonathan
Laudone, Vincent
Carver, Brett
Eastham, James A
Scardino, Peter T
author_facet Vickers, Andrew J
Bennette, Caroline
Touijer, Karim
Coleman, Jonathan
Laudone, Vincent
Carver, Brett
Eastham, James A
Scardino, Peter T
author_sort Vickers, Andrew J
collection PubMed
description 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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spelling pubmed-32987152012-03-11 Feasibility study of a clinically-integrated randomized trial of modifications to radical prostatectomy Vickers, Andrew J Bennette, Caroline Touijer, Karim Coleman, Jonathan Laudone, Vincent Carver, Brett Eastham, James A Scardino, Peter T Trials Research 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 BioMed Central 2012-02-24 /pmc/articles/PMC3298715/ /pubmed/22364367 http://dx.doi.org/10.1186/1745-6215-13-23 Text en Copyright ©2012 Vickers et al; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Research
Vickers, Andrew J
Bennette, Caroline
Touijer, Karim
Coleman, Jonathan
Laudone, Vincent
Carver, Brett
Eastham, James A
Scardino, Peter T
Feasibility study of a clinically-integrated randomized trial of modifications to radical prostatectomy
title Feasibility study of a clinically-integrated randomized trial of modifications to radical prostatectomy
title_full Feasibility study of a clinically-integrated randomized trial of modifications to radical prostatectomy
title_fullStr Feasibility study of a clinically-integrated randomized trial of modifications to radical prostatectomy
title_full_unstemmed Feasibility study of a clinically-integrated randomized trial of modifications to radical prostatectomy
title_short Feasibility study of a clinically-integrated randomized trial of modifications to radical prostatectomy
title_sort feasibility study of a clinically-integrated randomized trial of modifications to radical prostatectomy
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3298715/
https://www.ncbi.nlm.nih.gov/pubmed/22364367
http://dx.doi.org/10.1186/1745-6215-13-23
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