Back to resultsStaple vs. Suture in Robotic Prostatectomy
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Staple Ligation
Selective Suture Ligation
Single Suture Ligation
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer
Eligibility Criteria
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
Sites / Locations
- Swedish Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Staple Ligation
Selective Suture Ligation
Single Suture Ligation
Arm Description
Arm 1: Staple Ligation
Arm 2: Selective Suture Ligation
Arm 3: Single Suture Ligation
Outcomes
Primary Outcome Measures
Post-operative Continence Rates
The amount of time after surgery for a patient to regain continence (is no longer using pads).
Secondary Outcome Measures
Post-operative Erectile Function
The amount of time after surgery for a patient to regain erectile function.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03480074
Brief Title
Staple vs. Suture in Robotic Prostatectomy
Official Title
Endoscopic Stapling Versus Suture Ligation of Dorsal Venous Complex During Robot-Assisted Laparoscopic Prostatectomy: A Randomized Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2015 (Actual)
Primary Completion Date
November 1, 2018 (Actual)
Study Completion Date
October 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Swedish Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Staple Ligation
Arm Type
Active Comparator
Arm Description
Arm 1: Staple Ligation
Arm Title
Selective Suture Ligation
Arm Type
Active Comparator
Arm Description
Arm 2: Selective Suture Ligation
Arm Title
Single Suture Ligation
Arm Type
Active Comparator
Arm Description
Arm 3: Single Suture Ligation
Intervention Type
Procedure
Intervention Name(s)
Staple Ligation
Intervention Description
Using a stapler that staples the DVC and then cuts it.
Intervention Type
Procedure
Intervention Name(s)
Selective Suture Ligation
Intervention Description
Suture the DVC, suspend it to the pubic bone, and then cut.
Intervention Type
Procedure
Intervention Name(s)
Single Suture Ligation
Intervention Description
Cut the DVC, then pinpoint a specific blood vessel needed to sew/suture.
Primary Outcome Measure Information:
Title
Post-operative Continence Rates
Description
The amount of time after surgery for a patient to regain continence (is no longer using pads).
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Post-operative Erectile Function
Description
The amount of time after surgery for a patient to regain erectile function.
Time Frame
2 years
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Prostate study, only males eligible.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Porter, MD
Organizational Affiliation
Swedish Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Staple vs. Suture in Robotic Prostatectomy
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