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Modifications to Radical Prostatectomy: Feasibility Study

A Randomized Trial of Modifications to Radical Prostatectomy: Feasibility Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00928850
Enrollment
154
Registered
2009-06-26
Start date
2009-06-30
Completion date
2018-05-04
Last updated
2019-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

Prostate, Radical Prostatectomy, urethral irrigation, fascial suturing, 09-051

Brief summary

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.

Interventions

PROCEDUREradical 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

PROCEDUREradical 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

PROCEDUREradical 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

PROCEDUREradical 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

Sponsors

Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
21 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients scheduled for radical prostatectomy for the treatment of prostate cancer with one of the consenting surgeons at MSKCC.

Exclusion criteria

* Prior treatment for prostate cancer: radiation, hormonal therapy, chemotherapy or focal therapy.

Design outcomes

Primary

MeasureTime frame
To pilot a randomized trial of modifications to radical prostatectomy to determine:Proportion of patients accrued and Accrual rate1 year

Secondary

MeasureTime frame
Determine surgeon compliance with allocation1 year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 27, 2026