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Staple vs. Suture in Robotic Prostatectomy

S

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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