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NCT01613651 · ClinicalTrials.gov registry record · Phase 3
Robotic Assisted Laparoscopic Prostatectomy With or Without Pelvic Drain Placement in Reducing Adverse Events After Surgery in Patients With Prostate Cancer
A Phase 3 study, sponsored by City of Hope Medical Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 191
- Enrollment target
NCT01613651: Completed Phase 3 study, sponsored by City of Hope Medical Center.
NCT01613651 is a Phase 3 study that has completed, run by City of Hope Medical Center. The registered enrollment target is 191 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01613651, a Phase 3 study, has completed, sponsored by City of Hope Medical Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 191 participants
- Enrollment target
Study Summary
This randomized phase III trial studies robotic assisted laparoscopic prostatectomy (RALP) with pelvic drain placement to see how well it works compared to RALP without pelvic drain replacement in reducing adverse events after surgery in patients with prostate cancer.
Primary Outcome
The observed rate of adverse events among patients on the two arms of the study will be compared using a one-sided non-inferiority test with the intent to rule out a 10% or greater difference in postoperative adverse event rates.
Interventions
- OTHER questionnaire administration
- PROCEDURE robot-assisted laparoscopic surgery
- OTHER intraoperative complication management/prevention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 191 participants |
| Start Date | 2012-08-24 |
| Est. Completion | 2017-09-11 |
| Phase | Phase 3 |
What the finished NCT01613651 record still lists
NCT01613651 is an interventional study that assigns participants to a tested intervention. The registered 191 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 3 interventions - of which questionnaire administration is the first listed.
NCT01613651 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01613651 about?
NCT01613651 is a clinical study titled "Robotic Assisted Laparoscopic Prostatectomy With or Without Pelvic Drain Placement in Reducing Adverse Events After Surgery in Patients With Prostate Cancer". This randomized phase III trial studies robotic assisted laparoscopic prostatectomy (RALP) with pelvic drain placement to see how well it works compared to RALP without pelvic drain replacement in reducing adverse events after surgery in patients with prostate cancer.
What is the current status of trial NCT01613651?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 191 participants. The study started on 2012-08-24. Estimated completion is 2017-09-11.
What interventions are being tested in trial NCT01613651?
The interventions under investigation include: questionnaire administration (OTHER), robot-assisted laparoscopic surgery (PROCEDURE), intraoperative complication management/prevention (OTHER).
Who is sponsoring clinical trial NCT01613651?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01613651's enrollment target sits among peer trials
191 1402nd of 2000 higher than 599 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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