Prostate Cancer
Conditions
Brief summary
The purpose of the study is to compare the results of three standard of care surgical methods \[stapling versus selective suture ligation (cut, then sew) versus single suture ligation (sew, then cut) of the dorsal venous complex (DVC)\] during robotic prostate surgery to see which is better for the patient's recovery.
Detailed description
The dorsal venous complex (DVC) lies on top of the prostate gland, and carries blood away from the penis. It has to be tied off, or ligated, to remove the prostate gland. The DVC lies very close to nerves that help men get and maintain erections. In addition, the DVC is close to muscles that control passing urine. How the DVC is handled during prostate surgery may result in cancer being left behind to grow and spread in the body. The purpose of this study is to compare the results of stapling versus selective suture ligation (cut, then sew) versus single suture ligation (sew, then cut) of the DVC during robotic prostate surgery to see which is better for the patient's recovery. This research is being done because doctors do not know which of these three commonly-used methods is better to reduce blood loss and reduce the chance of cancer left behind during surgery, and regain urine control and improve erectile function after surgery. Doctors also do not know if these methods affect the prostate-specific antigen (PSA) level in the blood after surgery.
Interventions
PROCEDUREStaple Ligation
Using a stapler that staples the DVC and then cuts it.
PROCEDURESelective Suture Ligation
Suture the DVC, suspend it to the pubic bone, and then cut.
PROCEDURESingle Suture Ligation
Cut the DVC, then pinpoint a specific blood vessel needed to sew/suture.
Sponsors
Swedish Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males over 18 years of age * Must be scheduled to undergo standard of care robot-assisted laparoscopic prostatectomy (RALP) * Must sign informed consent to be randomized between the three surgical arms
Exclusion criteria
* Patient is unwilling or unable to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative Continence Rates | 2 years | The amount of time after surgery for a patient to regain continence (is no longer using pads). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative Erectile Function | 2 years | The amount of time after surgery for a patient to regain erectile function. |
Countries
United States
Outcome results
None listed