Staple vs. Suture in Robotic Prostatectomy
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
| Start Date: | March 1, 2015 |
| End Date: | January 1, 2020 |
Endoscopic Stapling Versus Suture Ligation of Dorsal Venous Complex During Robot-Assisted Laparoscopic Prostatectomy: A Randomized Prospective Study
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.
[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.
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.
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.
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
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