Clinical and Quality of Life Outcomes After Open or Robotic-Assisted Laparoscopic Radical Prostatectomy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00578123|
Recruitment Status : Active, not recruiting
First Posted : December 20, 2007
Last Update Posted : August 4, 2017
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer Quality of Life||Behavioral: Quality of Life Questionnaires||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||959 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Prospective Assessment of Clinical and Quality of Life Outcomes After Open or Robotic-Assisted Laparoscopic Radical Prostatectomy|
|Study Start Date :||July 2005|
|Estimated Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||July 2018|
Quality of Life Questionnaires
Behavioral: Quality of Life Questionnaires
Three surveys you will need to complete. We will give you the surveys during your regularly scheduled clinic visits at three, six, and twelve months after surgery. You will NOT be asked to make additional appointments just for the study. You will have the option of completing some of the surveys in an easy to use computer format in the clinic waiting area or on paper.
- To compare robotic-assisted radical prostatectomy (RALP), and open radical prostatectomy (ORP) with respect to potency function at 1 year, after adjusting for known confounding variables measured at baseline. [ Time Frame: 1 year ]
- To evaluate the recovery of continence after RALP or ORP. [ Time Frame: 2 years ]
- To evaluate patient convalescence after RALP or ORP. [ Time Frame: 2 years ]
- To evaluate operative details. [ Time Frame: 2 years ]Including operative time, blood loss, intraoperative fluid requirements, type of anesthesia, number and type of surgical drains, status of the neurovascular bundles including whether or not nerve grafting was performed, incision length, and other ancillary procedures for RALP or ORP
- To evaluate inpatient (hospital) details [ Time Frame: 2 years ]Including time in the post-anesthesia care unit, hospital convalescence, day of oral intake, day of ambulation, analgesia requirements, daily weights, length of time and output from surgical drains, hemoglobin and creatinine, complications, and length of hospital stay.
- To evaluate post-discharge (home) details. [ Time Frame: 2 years ]Including analgesic use, return to normal activities/work, time of urinary catheterization, need for catheter replacement, hemoglobin, complications, visit to emergency room or unscheduled clinic visits, and biochemical outcomes (serum PSA levels) following surgery.
- To evaluate health service utilization, out-of-pocket spending and changes in employment following RALP or ORP. [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00578123
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||James Eastham, MD||Memorial Sloan Kettering Cancer Center|