Staple vs. Suture in Robotic Prostatectomy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Endoscopic Stapling Versus Suture Ligation of Dorsal Venous Complex During Robot-Assisted Laparoscopic Prostatectomy: A Randomized Prospective Study

Conditions
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Prostate Cancer

Intervention / Treatment
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* Procedure: Staple Ligation
* Procedure: Selective Suture Ligation
* Procedure: Single Suture Ligation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Staple Ligation<br>Arm 1: Staple Ligation | Procedure: Staple Ligation<br>* Using a stapler that staples the DVC and then cuts it.<br>|
| Active Comparator: Selective Suture Ligation<br>Arm 2: Selective Suture Ligation | Procedure: Selective Suture Ligation<br>* Suture the DVC, suspend it to the pubic bone, and then cut.<br>|
| Active Comparator: Single Suture Ligation<br>Arm 3: Single Suture Ligation | Procedure: Single Suture Ligation<br>* Cut the DVC, then pinpoint a specific blood vessel needed to sew/suture.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative Erectile Function | The amount of time after surgery for a patient to regain erectile function. | 2 years |