Staple vs. Suture in Robotic Prostatectomy
Endoscopic Stapling Versus Suture Ligation of Dorsal Venous Complex During Robot-Assisted Laparoscopic Prostatectomy: A Randomized Prospective Study
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98122
- Swedish Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: Staple Ligation
Arm 1: Staple Ligation
|
Using a stapler that staples the DVC and then cuts it.
|
|
ACTIVE_COMPARATOR: Selective Suture Ligation
Arm 2: Selective Suture Ligation
|
Suture the DVC, suspend it to the pubic bone, and then cut.
|
|
ACTIVE_COMPARATOR: Single Suture Ligation
Arm 3: Single Suture Ligation
|
Cut the DVC, then pinpoint a specific blood vessel needed to sew/suture.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Post-operative Continence Rates
Time Frame: 2 years
|
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
Time Frame: 2 years
|
The amount of time after surgery for a patient to regain erectile function.
|
2 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PID 211077
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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