Trial reportTrials2012
Feasibility study of a clinically-integrated randomized trial of modifications to radical prostatectomy.
Trial report in Trials, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00928850 (A Randomized Trial of Modifications to Radical Prostatectomy), which is not on this map. Cited by 6 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Randomized Trial of Modifications to Radical Prostatectomy: Feasibility Study
Who cites it
6 citing papers in PubMed, 7 citations in OpenAlex.
- Limited versus Extended Pelvic Lymph Node Dissection for Prostate Cancer: A Randomized Clinical Trial.European urology oncology · 2021Trial
- Optimizing accrual to a large-scale, clinically integrated randomized trial in anesthesiology: A 2-year analysis of recruitment.Clinical trials (London, England) · 2025Article
- Have urinary function outcomes after radical prostatectomy improved over the past decade?Cancer · 2022Article
- Point-of-Care Clinical Trials in Sports Medicine Research: Identifying Effective Treatment Interventions Through Comparative Effectiveness Research.Journal of athletic training · 2020Article
- Clinical trials in crisis: Four simple methodologic fixes.Clinical trials (London, England) · 2014Article
- Can we deliver randomized trials of focal therapy in prostate cancer?Nature reviews. Clinical oncology · 2014Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 2 institutions in 1 country.
Funding
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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.