Staple vs. Suture in Robotic Prostatectomy

Not Applicable

Completed

• Conditions: Prostate Cancer

• Registration Number: NCT03480074
• Lead Sponsor: Swedish Medical Center

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 Timeline

• Study Start: 2015-03-01
• Study First Submitted: 2018-03-21
• Study First Submitted QC: 2018-03-21
• Study First Posted: 2018-03-27
• Primary Completion: 2018-11-01
• Study Completion: 2020-10-01
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-26
• Last Update Posted: 2022-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Post-operative Continence Rates	2 years	The amount of time after surgery for a patient to regain continence (is no longer using pads).

Secondary Outcome Measures

Name	Time	Method
Post-operative Erectile Function	2 years	The amount of time after surgery for a patient to regain erectile function.

Trial Locations

Locations (1)

Swedish Medical Center; 🇺🇸 Seattle, Washington, United States