Endoscopic Stapling Versus Suture Ligation of Dorsal Venous Complex During Robot-Assisted Laparoscopic Prostatectomy: A Randomized Prospective Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Swedish Medical Center
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Post-operative Continence Rates
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts 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
Arms & Interventions
Single Suture Ligation
Arm 3: Single Suture Ligation
Intervention: Single Suture Ligation (Procedure)
Selective Suture Ligation
Arm 2: Selective Suture Ligation
Intervention: Selective Suture Ligation (Procedure)
Staple Ligation
Arm 1: Staple Ligation
Intervention: Staple Ligation (Procedure)
Outcomes
Primary Outcomes
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).
Secondary Outcomes
- Post-operative Erectile Function(2 years)