NCT03480074

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable prostate-cancer

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

March 21, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 27, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

July 28, 2022

Status Verified

July 1, 2022

Enrollment Period

3.7 years

First QC Date

March 21, 2018

Last Update Submit

July 26, 2022

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • Post-operative Continence Rates

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

    2 years

Secondary Outcomes (1)

  • Post-operative Erectile Function

    2 years

Study Arms (3)

Staple Ligation

ACTIVE COMPARATOR

Arm 1: Staple Ligation

Procedure: Staple Ligation

Selective Suture Ligation

ACTIVE COMPARATOR

Arm 2: Selective Suture Ligation

Procedure: Selective Suture Ligation

Single Suture Ligation

ACTIVE COMPARATOR

Arm 3: Single Suture Ligation

Procedure: Single Suture Ligation

Interventions

Staple LigationPROCEDURE

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

Staple Ligation
Selective Suture LigationPROCEDURE

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

Selective Suture Ligation
Single Suture LigationPROCEDURE

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

Single Suture Ligation

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsProstate study, only males eligible.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patient is unwilling or unable to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Swedish Medical Center

Seattle, Washington, 98122, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • James Porter, MD

    Swedish Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2018

First Posted

March 27, 2018

Study Start

March 1, 2015

Primary Completion

November 1, 2018

Study Completion

October 1, 2020

Last Updated

July 28, 2022

Record last verified: 2022-07

Locations

US(1)