Staple vs. Suture in Robotic Prostatectomy

NCT ID: NCT03480074

Last Updated: 2022-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-01

Study Completion Date

2020-10-01

Brief Summary

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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

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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.

Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Staple Ligation

Arm 1: Staple Ligation

Group Type ACTIVE_COMPARATOR

Staple Ligation

Intervention Type PROCEDURE

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

Selective Suture Ligation

Arm 2: Selective Suture Ligation

Group Type ACTIVE_COMPARATOR

Selective Suture Ligation

Intervention Type PROCEDURE

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

Single Suture Ligation

Arm 3: Single Suture Ligation

Group Type ACTIVE_COMPARATOR

Single Suture Ligation

Intervention Type PROCEDURE

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

Interventions

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Staple Ligation

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

Intervention Type PROCEDURE

Selective Suture Ligation

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

Intervention Type PROCEDURE

Single Suture Ligation

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Swedish Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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James Porter, MD

Role: PRINCIPAL_INVESTIGATOR

Swedish Medical Center

Locations

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Swedish Medical Center

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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PID 211077

Identifier Type: -

Identifier Source: org_study_id

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