Staple vs. Suture in Robotic Prostatectomy

Swedish Medical Center

Status: Completed

Conditions: Prostate Cancer

Treatments: Procedure: Staple Ligation; Procedure: Single Suture Ligation; Procedure: Selective Suture Ligation

Study type: Interventional

Funder types: Other

Identifiers

NCT03480074

PID 211077

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 3 patient groups

Staple Ligation

Active Comparator group

Description:

Arm 1: Staple Ligation

Treatment:

Procedure: Staple Ligation

Selective Suture Ligation

Active Comparator group

Description:

Arm 2: Selective Suture Ligation

Treatment:

Procedure: Selective Suture Ligation

Single Suture Ligation

Active Comparator group

Description:

Arm 3: Single Suture Ligation

Treatment:

Procedure: Single Suture Ligation