Prostate CancerNCT03480074
Staple vs. Suture in Robotic Prostatectomy
A study testing Staple Ligation, Selective Suture Ligation and Single Suture Ligation in people with Prostate Cancer, run by Swedish Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Staple Ligation, Selective Suture Ligation and Single Suture Ligation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2015to 1 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patient is unwilling or unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endoscopic Stapling Versus Suture Ligation of Dorsal Venous Complex During Robot-Assisted Laparoscopic Prostatectomy: A Randomized Prospective Study
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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- Staple Ligation, Selective Suture Ligation, Single Suture Ligation
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Staple LigationProcedure or surgery
Using a stapler that staples the DVC and then cuts it.
Selective Suture LigationProcedure or surgery
Suture the DVC, suspend it to the pubic bone, and then cut.
Single Suture LigationProcedure or surgery
Cut the DVC, then pinpoint a specific blood vessel needed to sew/suture.
| Study group | Role | What they receive |
|---|---|---|
| Staple Ligation | Active comparator | Arm 1: Staple Ligation Receives: Procedure: Staple Ligation |
| Selective Suture Ligation | Active comparator | Arm 2: Selective Suture Ligation Receives: Procedure: Selective Suture Ligation |
| Single Suture Ligation | Active comparator | Arm 3: Single Suture Ligation Receives: Procedure: Single Suture Ligation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative Continence Rates
The amount of time after surgery for a patient to regain continence (is no longer using pads).
Measured: 2 years
Secondary outcomes (1)
Post-operative Erectile Function
The amount of time after surgery for a patient to regain erectile function.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start1 Mar 2015
- Primary completion1 Nov 2018
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swedish Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James Porter, MD, Principal investigator, Swedish Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03480074
- Sponsor's protocol ID
- PID 211077
- Status last verified
- Jul 2022
- First submitted
- 21 Mar 2018
- Last updated
- 28 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Stapling Versus Suture Ligation of Dorsal Venous Complex During Robot-Assisted Laparoscopic Prostatectomy: A Randomized Prospective Study
- ClinicalTrials.gov ID
- NCT03480074
- Acronym / sponsor ID
- PID 211077
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Swedish Medical CenterUniversity, hospital or other
- Study start
- 1 Mar 2015 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 27 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Staple Ligation | Active comparator | Procedure: Staple LigationArm 1: Staple Ligation |
| Selective Suture Ligation | Active comparator | Procedure: Selective Suture LigationArm 2: Selective Suture Ligation |
| Single Suture Ligation | Active comparator | Procedure: Single Suture LigationArm 3: Single Suture Ligation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Patient is unwilling or unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Staple LigationUsing a stapler that staples the DVC and then cuts it. | Procedure or surgery | Staple Ligation |
| Selective Suture LigationSuture the DVC, suspend it to the pubic bone, and then cut. | Procedure or surgery | Selective Suture Ligation |
| Single Suture LigationCut the DVC, then pinpoint a specific blood vessel needed to sew/suture. | Procedure or surgery | Single Suture Ligation |
Primary outcome
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).
1 secondary outcome
Post-operative Erectile Function
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Porter, MD principal investigator
Swedish Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Staple Ligation, Selective Suture Ligation and Single Suture Ligation in people with Prostate Cancer, run by Swedish Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative Continence Rates (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2022.