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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Staple Ligation | Active Comparator | Arm 1: Staple Ligation |
|
| Selective Suture Ligation | Active Comparator | Arm 2: Selective Suture Ligation |
|
| Single Suture Ligation | Active Comparator | Arm 3: Single Suture Ligation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Staple Ligation | Procedure | Using a stapler that staples the DVC and then cuts it. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative Continence Rates | The amount of time after surgery for a patient to regain continence (is no longer using pads). | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative Erectile Function | The amount of time after surgery for a patient to regain erectile function. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
Prostate study, only males eligible.
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| Name | Affiliation | Role |
|---|---|---|
| James Porter, MD | Swedish Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Swedish Medical Center | Seattle | Washington | 98122 | United States |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Selective Suture Ligation |
| Procedure |
Suture the DVC, suspend it to the pubic bone, and then cut. |
|
| Single Suture Ligation | Procedure | Cut the DVC, then pinpoint a specific blood vessel needed to sew/suture. |
|
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |