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NCT00963859 · ClinicalTrials.gov registry record · Phase 2
Robotic-Assisted Laparoscopic Extended Pelvic Lymph Node Dissection for Transitional Cell Carcinoma of the Bladder
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 11
- Enrollment target
NCT00963859: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT00963859 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 11 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00963859, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 11 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to evaluate how many lymph nodes are left behind after robotic-assisted removal and are then found after a wider incision is made, in patients who are having their bladder removed for the treatment of bladder cancer. The primary objective is to compare the lymph node yield achieved by performing a robotic-assisted laparoscopic extended pelvic lymph node dissection (RA-PLND) compared to a second-look open lymph node dissection (O-PLND) among patients undergoing radical cystectomy for transitional cell carcinoma of the bladder. The secondary objectives will be to collect prospective outcomes data related to the performance of RA-PLND and robotic-assisted cystectomy (RA-C) including operative times, estimated blood loss, transfusions, complications, return to diet, utilization of pain medication, hospital length, return to regular activities.
Primary Outcome
The median yield (the lymph node count) allows for comparison of how many lymph nodes are left behind after robotic-assisted removal and are then found after a wider incision is made. Specifically a robot-assisted laparoscopic extended pelvic lymph node dissection (RA-PLND) is compared to a second-look open lymph node dissection (O-PLND) among participants undergoing radical cystectomy for urothelial carcinoma of the bladder. The median yield lymph nodes illustrate the adequacy of extended pelvi
Interventions
- PROCEDURE Robotic-assisted laparoscopic surgery
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2007-10 |
| Est. Completion | 2011-06 |
| Phase | Phase 2 |
What the finished NCT00963859 record still lists
NCT00963859 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which Robotic-assisted laparoscopic surgery is the first listed.
NCT00963859 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00963859 about?
NCT00963859 is a clinical study titled "Robotic-Assisted Laparoscopic Extended Pelvic Lymph Node Dissection for Transitional Cell Carcinoma of the Bladder". The goal of this clinical research study is to evaluate how many lymph nodes are left behind after robotic-assisted removal and are then found after a wider incision is made, in patients who are having their bladder removed for the treatment of bladder cancer. The primary objective is to compare th...
What is the current status of trial NCT00963859?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 11 participants. The study started on 2007-10. Estimated completion is 2011-06.
What interventions are being tested in trial NCT00963859?
The interventions under investigation include: Robotic-assisted laparoscopic surgery (PROCEDURE).
Who is sponsoring clinical trial NCT00963859?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00963859's enrollment target sits among peer trials
11 1967th of 2000 higher than 33 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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