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


Authors: Vickers, A. J.; Bennette, C.; Touijer, K.; Coleman, J.; Laudone, V.; Carver, B.; Eastham, J. A.; Scardino, P. T.
Article Title: 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 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.ClinicalTrials.gov NCT00928850. © 2012 Vickers et al; licensee BioMed Central Ltd.
Keywords: adult; controlled study; treatment outcome; aged; middle aged; major clinical study; clinical trial; cancer recurrence; united states; cancer patient; research design; methodology; controlled clinical trial; randomized controlled trial; pathology; high risk patient; prostate cancer; prostatic neoplasms; feasibility study; feasibility studies; randomized controlled trials; prostatectomy; prostate tumor; surgery; new york city; suture techniques; suturing method; lavage; therapeutic irrigation; fascia
Journal Title: Trials
Volume: 13
ISSN: 1745-6215
Publisher: Biomed Central Ltd  
Date Published: 2012-02-24
Start Page: 23
Language: English
DOI: 10.1186/1745-6215-13-23
PROVIDER: scopus
PMCID: PMC3298715
PUBMED: 22364367
DOI/URL:
Notes: --- - "Export Date: 2 April 2012" - "Source: Scopus"
Altmetric Score
MSK Authors
  1. Jonathan Coleman
    184 Coleman
  2. Vincent Laudone
    59 Laudone
  3. Peter T Scardino
    621 Scardino
  4. Abdelkrim Karim Touijer
    190 Touijer
  5. Andrew J Vickers
    556 Vickers
  6. James Eastham
    426 Eastham
  7. Brett Stewart Carver
    109 Carver