NCT03480074

Staple vs. Suture in Robotic Prostatectomy

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Swedish Medical Center · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
PROCEDURE	Staple Ligation	Using a stapler that staples the DVC and then cuts it.
PROCEDURE	Selective Suture Ligation	Suture the DVC, suspend it to the pubic bone, and then cut.
PROCEDURE	Single Suture Ligation	Cut the DVC, then pinpoint a specific blood vessel needed to sew/suture.

Timeline

• Start date: 2015-03-01
• Primary completion: 2018-11-01
• Completion: 2020-10-01
• First posted: 2018-03-27
• Last updated: 2022-07-28

Locations

1 site across 1 country: United States