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Completed

NCT Number: NCT03480074

Staple vs. Suture in Robotic Prostatectomy

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Swedish Medical Center

Seattle, Washington, 98122, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Staple Ligation

Procedure

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

Selective Suture Ligation

Procedure

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

Single Suture Ligation

Procedure

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

Primary outcomes

  1. 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

  1. Post-operative Erectile Function

    Time frame: 2 years

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

Sponsors and collaborators

Lead sponsor

Swedish Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2020
First posted
Mar 27, 2018
Registry last updated
Jul 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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