Modifications to Radical Prostatectomy: Feasibility Study
NCT ID: NCT00928850
Last Updated: 2019-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
154 participants
INTERVENTIONAL
2009-06-30
2018-05-04
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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urethral irrigation but no fascial suturing, QOL forms
The anterior two-thirds of the urethra is divided exposing a Foley catheter that was placed at the beginning of the procedure. Irrigation of the urethra may prevent spread of prostate cancer cells to tissue that is not removed during surgery. The urethra is irrigated with 60 cc of sterile water as it is withdrawn from the patient to 'wash' the urethra.
radical prostatectomy with urethral irrigation but no fascial suturing, QOL forms
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
fascial suturing but no urethral irrigation, QOL forms
For patients undergoing fascial suturing only, after the initial placement of the suture through the urethra a second bite is taken deeply into the fascia of the lateral pelvic fascia.
radical prostatectomy with fascial suturing but no urethral irrigation, QOL forms
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
both urethral irrigation and fascial suturing, QOL forms
radical prostatectomy with both urethral irrigation and fascial suturing, QOL forms
Quality of life are assessed for clinical evaluation approximately 3, 6, 9, 12, 18, 24, 36 and 48 months after surgery
neither urethral irrigation nor fascial suturing, QOL forms
radical prostatectomy with neither urethral irrigation nor fascial suturing, QOL forms
Quality of life are assessed for clinical evaluation approximately 3, 6, 9, 12, 18, 24, 36 and 48 months after surgery
Interventions
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radical prostatectomy with urethral irrigation but no fascial suturing, QOL forms
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
radical prostatectomy with fascial suturing but no urethral irrigation, QOL forms
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
radical prostatectomy with both urethral irrigation and fascial suturing, QOL forms
Quality of life are assessed for clinical evaluation approximately 3, 6, 9, 12, 18, 24, 36 and 48 months after surgery
radical prostatectomy with neither urethral irrigation nor fascial suturing, QOL forms
Quality of life are assessed for clinical evaluation approximately 3, 6, 9, 12, 18, 24, 36 and 48 months after surgery
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
21 Years
MALE
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Andrew Vickers, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan Kettering Cancer Center
New York, New York, United States
Countries
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References
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Vickers AJ, Bennette C, Touijer K, Coleman J, Laudone V, Carver B, Eastham JA, Scardino PT. Feasibility study of a clinically-integrated randomized trial of modifications to radical prostatectomy. Trials. 2012 Feb 24;13:23. doi: 10.1186/1745-6215-13-23.
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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09-051
Identifier Type: -
Identifier Source: org_study_id
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