Staple vs. Suture in Robotic Prostatectomy

Swedish Medical Center300 enrolled

Overview

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.

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

300

Conditions

Prostate Cancer

Interventions

Staple LigationPROCEDURE

Using a stapler that staples the DVC and then cuts it.

Selective Suture LigationPROCEDURE

Suture the DVC, suspend it to the pubic bone, and then cut.

Single Suture LigationPROCEDURE

Cut the DVC, then pinpoint a specific blood vessel needed to sew/suture.

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Swedish Medical Center

Seattle, Washington, United States

Outcomes

Primary Outcomes

Post-operative Continence Rates

The amount of time after surgery for a patient to regain continence (is no longer using pads).

Time frame: 2 years

Secondary Outcomes

Post-operative Erectile Function

The amount of time after surgery for a patient to regain erectile function.

Time frame: 2 years

Data from ClinicalTrials.gov

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