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NCT01325506 · ClinicalTrials.gov registry record
Effectiveness of Open and Robotic Prostatectomy
A clinical trial, sponsored by Beth Israel Deaconess Medical Center.
- Completed
- Registry status
- 677
- Enrollment target
NCT01325506: Completed study, sponsored by Beth Israel Deaconess Medical Center.
NCT01325506 is a clinical trial that has completed, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 677 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01325506 has completed, sponsored by Beth Israel Deaconess Medical Center.
- COMPLETED
- Registry status
- 677 participants
- Enrollment target
Study Summary
Prostate cancer is the most common cancer in American men. Surgical removal of the entire prostate (prostatectomy) is one option among the various ways to treat prostate cancer. The use of robot assistance for prostatectomy has become common place, but its effectiveness has not been compared to standard open prostatectomy in trials carried out at more than one medical institution in which participants are identified and followed forward in time. Robot assisted and standard open prostatectomy health related quality of life (HRQOL) outcomes have not been compared in a prospective, multi-centered study. Prostatectomy can have side effects that can change with time. This research study seeks to determine how common and how long-lasting such side effects are; to find out what features of individual men's cancers and what features of the treatments affect those side effects. This study also seeks to identify factors that affect the quality of prostate cancer care by looking at how satisfied men are with their prostate cancer care. Through these findings, this study aims to allow treatment side effects to be anticipated more accurately for individual patients, and to provide a means for determining the quality of prostate care.
Primary Outcome
Outcomes include: acute clinical morbidity (thromboembolic events, bleeding requiring transfusion, surgical infection, other events requiring intervention within 30 days of prostatectomy) and satisfaction with overall treatment outcome; cancer control (surgical margins, PSA recurrence-free survival, requirement of salvage or adjuvant treatment).
Interventions
- OTHER Questionnaire
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 677 participants |
| Start Date | 2010-09 |
| Est. Completion | 2024-10 |
What the finished NCT01325506 record still lists
NCT01325506 is an observational study that tracks outcomes without assigning an intervention. The registered 677 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Questionnaire is the first listed.
NCT01325506 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01325506 about?
NCT01325506 is a clinical study titled "Effectiveness of Open and Robotic Prostatectomy". Prostate cancer is the most common cancer in American men. Surgical removal of the entire prostate (prostatectomy) is one option among the various ways to treat prostate cancer. The use of robot assistance for prostatectomy has become common place, but its effectiveness has not been compared to stan...
What is the current status of trial NCT01325506?
This trial is currently completed. The enrollment target is 677 participants. The study started on 2010-09. Estimated completion is 2024-10.
What interventions are being tested in trial NCT01325506?
The interventions under investigation include: Questionnaire (OTHER).
Who is sponsoring clinical trial NCT01325506?
This trial is sponsored by Beth Israel Deaconess Medical Center, which has 488 total clinical trials registered on ClinicalTrials.gov.
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