Return to List

Study Summary
No. 2007-0441:.......Bladder......John W. Davis......Urology
.
Study Summary Title
Study Summary
Number:		2007-0441
Study Title:Phase II evaluation of robotic-assisted laparoscopic extended pelvic lymph node dissection for transitional cell carcinoma of the bladder.
.
Physician New Patient Referral
Name:John W. DavisPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:UrologyReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-3250
Contact us about clinical trials
.
General Information
Disease Group:BladderSupported By:N/A
Phase of Study:Phase IIReturn
Visit:		Patients will return to MDACC every 3 months on average for a standard of care
visit. Data will be collected up to postoperative day 42. This data will
include information about pain medication which will be collected by a patient
diary.
Treatment
Agents:		Surgical Device
Surgical Procedure		Home Care:Patients must learn how to care for an ostomy device (ileal conduit) or how to
perform self catheterization (neobladder construction). This is standard of
care
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:		Hospital stay for radical cystectomy averages 7 days.
Description/
Intervention:		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.
.
Study Objectives / Outcomes
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 Status Information
Study Activation / Registration Date:10/10/2007
IRB Review and Approval Date:10/10/2007
Study Type:Phase Ii Or Phase I/Ii
Recruitment Status:Terminated
Projected Accrual:N/A
.
Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
Inclusion Criteria:1) Patients who are eligible for a radical cystectomy and who, in the opinion of the treating MDACC physician, are candidates for a robotic-assisted laparoscopic technique for management of the bladder and lymph nodes.

2) Diagnosis of transitional cell carcinoma of the bladder

3) Medical fitness for open radical cystectomy by consensus of MDACC urology and anesthesia faculty (medicine/cardiology clearance by common best practice criteria).

4) Staging inclusion by cystoscopic biopsy and bimanual examination under anesthesia: carcinoma in-situ, T1, T2.
Exclusion Criteria:1) Prior pelvic radiation.

2) Morbid obesity, i.e. BMI > 35

3) Metastatic disease, bulky disease--T3a/b, prostatic stromal invasion

4) Non-transitional cell histology
.
Links
Registration Number: NCT00963859
Study Information on Clinical Trials Registry (clinicaltrials.gov)
Other Links:
.
Results

Return to Clinical Trials at M.D. Anderson Cancer Center