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.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT00928850.
authors.affiliation: Department of Epidemiology and Biostatistics, Memorial Sloan-Kettering Cancer Center, New York, NY 11215, USA. vickersa@mskcc.org
authors.forename: Andrew J
authors.initials: AJ
authors.lastname: Vickers
authors.forename: Caroline
authors.initials: C
authors.lastname: Bennette
authors.forename: Karim
authors.initials: K
authors.lastname: Touijer
authors.forename: Jonathan
authors.initials: J
authors.lastname: Coleman
authors.forename: Vincent
authors.initials: V
authors.lastname: Laudone
authors.forename: Brett
authors.initials: B
authors.lastname: Carver
authors.forename: James A
authors.initials: JA
authors.lastname: Eastham
authors.forename: Peter T
authors.initials: PT
authors.lastname: Scardino
mesh_terms: D000368:Aged; D000071938:Fasciotomy; D005240:Feasibility Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009519:New York City; D011468:Prostatectomy / Q000379:methods*; D011471:Prostatic Neoplasms / Q000473:pathology / Q000601:surgery*; D012107:Research Design; D013536:Suture Techniques; D007507:Therapeutic Irrigation; D016896:Treatment Outcome