Prostate CancerNCT03351088
Outcomes From a RCT Comparing Preventive Versus Delayed Ligation of DVC During Robot-assisted Radical Prostatectomy
A study testing DVC ligation in people with Prostate Cancer, run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia at 1 site in Italy.
Trial summary
Since its introduction, robot-assisted radical prostatectomy (RARP) have become the standard surgical approach for the treatment of prostate cancer in the United States and then in Europe. Continuous refinements of surgical technique has been described in order to maximise outcomes while minimizing morbidities. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- DVC ligation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 226 participants
- Where
- 1 siteItaly
- Study dates
- Aug 2016to Dec 2017
- 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 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male patients, aged 18-80 years
- patients willing and able to provide written informed consent
- voluntary partecipation
- clinical indication to robot-assisted radical prostatectomy
Who cannot join
- coagulation impairment at the time of surgery
- salvage radical prostatectomy
Trial locations and contacts
1 site in 1 country.
Italy1 site
Clinical Department of Urology, university Hospital Spedali Civili di Brescia
Brescia, 25123
About this study
Official title: Outcomes of a Phase III Randomized Controlled Trial Comparing Preventive Versus Delayed Ligation of Dorsal Vascular Complex During Robot-assisted Radical Prostatectomy
Since its introduction, robot-assisted radical prostatectomy (RARP) have become the standard surgical approach for the treatment of prostate cancer in the United States and then in Europe. Continuous refinements of surgical technique has been described in order to maximise outcomes while minimizing morbidities.
The management of DVC is a crucial steps during RARP. It could be done prior or after its transection thanks to haemostatic effects of the pneumoperitoneum. This topic has been already investigated by some authors. However, no high quality evidence is available to opt in favour of either of the two approaches. Findings about estimated blood loss, positive surgical margins and urinary recovery differ among these studies and only one is a randomized controlled trial in a laparoscopic setting with a limited number of patients.
Therefore, our objective was to evaluate in a prospective randomised setting whether a delayed ligation of the dorsal vascular complex impacted on perioperative, functional and oncological outcomes as compared to preventive ligation during robot-assisted radical prostatectomy.
- Conditions
- Prostate Cancer
- Being tested
- DVC 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.
DVC ligationProcedure or surgery
Ligation of the dorsal vascular complex during robot-assisted radical prostatectomy
| Study group | Role | What they receive |
|---|---|---|
| Preventive ligation | Other | Preventive ligation of DVC is done after the opening of endopelvic fascia and before bladder neck dissection. DVC is ligated at the level of the apex with a 8-fashion single stich (1-0 Monocryl® CT-1 stich) trying to preserve puboprostatic ligaments and the muscle fibres of the rabdosphincter. DVC is then dissected at the end of prostatectomy before the section of the urethra. Receives: Procedure: DVC ligation |
| Delayed ligation | Other | Delayed ligation is done after the section of the urethra and once the prostatectomy is completed with a single stich (3-0 Monocryl® UR-6). Receives: Procedure: DVC ligation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative estimated bool loss
Measured: intraoperative
Secondary outcomes (5)
Transfusion rate
Measured: 30 days from surgery
Overall positive surgical marigins
Measured: intraoperative
Apical positive surgicals margins
Measured: intraoperative
1-month continence
0 or 1 security pad per day
Measured: 30 days from surgery
1-month PSA
Measured: 30 days from surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2017
- Study startAug 2016
- Primary completionNov 2017 (estimated)
- Study completionDec 2017 (estimated)
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
- 226 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessandro Antonelli, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03351088
- Sponsor's protocol ID
- DVC
- Status last verified
- Nov 2017
- First submitted
- 19 Nov 2017
- Last updated
- 22 Nov 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of a Phase III Randomized Controlled Trial Comparing Preventive Versus Delayed Ligation of Dorsal Vascular Complex During Robot-assisted Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT03351088
- Acronym / sponsor ID
- DVC
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 226 participants (estimated)
- Lead sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 22 Nov 2017 (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.
Since its introduction, robot-assisted radical prostatectomy (RARP) have become the standard surgical approach for the treatment of prostate cancer in the United States and then in Europe. Continuous refinements of surgical technique has been described in order to maximise outcomes while minimizing morbidities.
The management of DVC is a crucial steps during RARP. It could be done prior or after its transection thanks to haemostatic effects of the pneumoperitoneum. This topic has been already investigated by some authors. However, no high quality evidence is available to opt in favour of either of the two approaches. Findings about estimated blood loss, positive surgical margins and urinary recovery differ among these studies and only one is a randomized controlled trial in a laparoscopic setting with a limited number of patients.
Therefore, our objective was to evaluate in a prospective randomised setting whether a delayed ligation of the dorsal vascular complex impacted on perioperative, functional and oncological outcomes as compared to preventive ligation during robot-assisted radical prostatectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preventive ligation | Other | Procedure: DVC ligationPreventive ligation of DVC is done after the opening of endopelvic fascia and before bladder neck dissection. DVC is ligated at the level of the apex with a 8-fashion single stich (1-0 Monocryl® CT-1 stich) trying to preserve puboprostatic ligaments and the muscle fibres of the rabdosphincter. DVC is then dissected at the end of prostatectomy before the section of the urethra. |
| Delayed ligation | Other | Procedure: DVC ligationDelayed ligation is done after the section of the urethra and once the prostatectomy is completed with a single stich (3-0 Monocryl® UR-6). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- male patients, aged 18-80 years
- patients willing and able to provide written informed consent
- voluntary partecipation
- clinical indication to robot-assisted radical prostatectomy
Key exclusion criteria (2 listed)
- coagulation impairment at the time of surgery
- salvage radical prostatectomy
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 |
|---|---|---|
| DVC ligationLigation of the dorsal vascular complex during robot-assisted radical prostatectomy | Procedure or surgery | Delayed ligation, Preventive ligation |
Primary outcome
Intraoperative estimated bool loss
Time frame: intraoperative
5 secondary outcomes
Transfusion rate
Time frame: 30 days from surgery
Overall positive surgical marigins
Time frame: intraoperative
Apical positive surgicals margins
Time frame: intraoperative
1-month continence
Time frame: 30 days from surgery
1-month PSA
Time frame: 30 days from surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2017.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DVC ligation in people with Prostate Cancer, run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia at 1 site in Italy.
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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 22 Nov 2017. 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 Italy. 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?
Results are not available in the source record.
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?
Intraoperative estimated bool loss (time frame: intraoperative). 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 22 Nov 2017.