CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 11 enrolled
Drug / intervention
Robotic-assisted laparoscopic surgeryprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00963859
NCT00963859Phase 2Completed

Phase II Evaluation of Robotic-assisted Laparoscopic Extended Pelvic Lymph Node Dissection for Transitional Cell Carcinoma of the Bladder

M.D. Anderson Cancer Center·interventional·Posted Aug 24, 2009·Updated May 21, 2013

In Brief

A Phase 2 clinical trial evaluating Robotic-assisted laparoscopic surgery for Bladder Cancer. Completed, enrolled 11 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBladder Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 24, 2009
Enrollment StartOct 1, 2007
Primary CompletionJun 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 16.9 years ago

Interventions

Robotic-assisted laparoscopic surgeryprocedure

During radical cystectomy, robotic-assisted technique used to perform cystectomy and pelvic lymph node dissections. Each patient will undergo a second-look open lymph node dissection once the incision is made at the end for the urinary diversion.