Memorial Sloan Kettering Cancer Center
New York, 10065, United States
NCT Number: NCT00928850
This study aims to determine whether surgeons at Memorial Sloan-Kettering Cancer Center are able to randomize patients to test modifications of surgery to remove the prostate. Surgery to remove the prostate is known as a "radical prostatectomy". Surgeons know many things about the best way to do a radical prostatectomy. However, there is disagreement about some aspects of surgery. Two modifications of surgery to remove the prostate (radical prostatectomy) identified for this study include Irrigation, and Fascial Suturing.
Two aspects of the operation may vary, fascial suturing and urethral irrigation. For each aspect, surgeons will use their clinical judgment as to the best interests of the patient. In other words, if there are clear reasons to use or avoid a fascial suturing approach, the surgeon will act accordingly; similarly, if there is a clear reason to irrigate or avoid irrigating the urethra, the surgeon can make the appropriate clinical decision. If the surgeon is unsure as to which approach to take, then the randomization scheme will be followed.
All of the surgeons who are taking part in this study have used these techniques at different times. However, they are unsure as to the best approach. Sometimes, they use different treatments with different patients.
Irrigation. Cancer cells can spill during surgery and this can cause cancer to return ("recur"). Some surgeons believe that "irrigating" could help stop spilling of cancer cells. "Irrigating" means washing the surgical area with sterile water and sucking the water back up through a tube. As a result, surgeons vary as to how they irrigate. In this study, we will examine irrigation of the urethra. This is the part of the body that carries urine from the bladder to the penis.
Fascial suturing. Surgeons believe that what happens to the urethra can affect the risk of incontinence. This is when a patient cannot control urine, and drips or leaks urine. One idea is that additional stitches ("sutures") to the connective tissue ("fascia") could be helpful, but this is not known for sure.
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Notify Me21 year and older
Male
Interventional
Not applicable
New York, 10065, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Cancer cells can spill during surgery and this can cause cancer to return ("recur"). Some surgeons believe that "irrigating" could help stop spilling of cancer cells. "Irrigating" means washing the surgical area with sterile water and sucking the water back up through a tube. As a result, surgeons vary as to how they irrigate. In this study, we will examine irrigation of the urethra. This is the part of the body that carries urine from the bladder to the penis. Quality of life are assessed for clinical evaluation approximately 3, 6, 9, 12, 18, 24, 36 and 48 months after surgery
Surgeons believe that what happens to the urethra can affect the risk of incontinence. This is when a patient cannot control urine, and drips or leaks urine. One idea is that additional stitches ("sutures") to the connective tissue ("fascia") could be helpful, but this is not known for sure. Quality of life are assessed for clinical evaluation approximately 3, 6, 9, 12, 18, 24, 36 and 48 months after surgery
Quality of life are assessed for clinical evaluation approximately 3, 6, 9, 12, 18, 24, 36 and 48 months after surgery
Quality of life are assessed for clinical evaluation approximately 3, 6, 9, 12, 18, 24, 36 and 48 months after surgery
Time frame: 1 year
Time frame: 1 year
Memorial Sloan Kettering Cancer Center
Other
A Randomized Trial of Modifications to Radical Prostatectomy: Feasibility Study
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