Prostate Cancer SurgeryNCT06670924
Suturing Techniques for Vesico-urethral Anastomosis
A study testing Running suture for vesico-urethral anastomosis in open radical prostatectomy and interrupted suture for vesico-urethral anastomosis in open radical prostatectomy in people with Prostate Cancer Surgery, run by Kartal City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Radical prostatectomy (RP) is the most common curative treatment for prostate cancer (PCa).Vesicourethral anastomosis (VUA) is a crucial step and either a conventional interrupted (IS) or a running (RS) suture is employed during radical prostatectomy (RP). Certainly, both RS and IS have advantages and limitations. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer Surgery
- What is being tested?
- Running suture for vesico-urethral anastomosis in open radical prostatectomy and interrupted suture for vesico-urethral anastomosis in open radical prostatectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Feb 2022to 16 Aug 2024
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis of clinically localised (pT1-pT2) prostate cancer
- must select the open radical prostatectomy procedure as a treatment option.
Who cannot join
- History of acute urinary retention
- History of urethral stricture
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences Kartal Dr. Lütfi Kırdar City Hospital
Istanbul, Istanbul, 34865
About this study
Official title: A Pragmatic Randomized Controlled Trial Comparing the Effects of Suturing Techniques for Vesico-urethral Anastomosis on One-year Voiding Function After Radical Prostatectomy
Radical prostatectomy (RP) is the most common curative treatment for prostate cancer (PCa).Vesicourethral anastomosis (VUA) is a crucial step and either a conventional interrupted (IS) or a running (RS) suture is employed during radical prostatectomy (RP). Certainly, both RS and IS have advantages and limitations. The metanalysis revealed that potential advantages for RS compared to IS, especially for short-term outcomes such as catheterization time, extravasation rate, and anastomotic suture time. There were no significant differences for long-term outcomes (continence, incidence of vesicourethral anastomotic stenosis). Generally, the exciting evidence suggests that CS should be preferred over IS. However, this should be followed only if it is technically feasible and appropriate regarding the surgical approach. Both techniques seem to be safe and appropriate for the VUA, and the technique should be chosen based on individual experience and preference.
The investigators hypothesized that RS and IS may have different effects on voiding function and flow rate, even if they do not cause an anastomotic stenosis requiring intervention. Furthermore, there is no existing literature that compares RS and IS in terms of voiding function.This article focuses on one year uroflowmetric voiding parameters, urinary function (UF), and UF related bother function, urinary continence recovery as well as other secondary outcomes, including surgical parameters, perioperative morbidity and oncological outcomes.
- Conditions
- Prostate Cancer Surgery
- Being tested
- Running suture for vesico-urethral anastomosis in open radical prostatectomy, interrupted suture for vesico-urethral anastomosis in open radical prostatectomy
- Keywords
- prostate cancer, vesicourethral anastomosis, voiding function, suture
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Running suture for vesico-urethral anastomosis in open radical prostatectomyProcedure or surgery
The surgical technique of the RS followed the description of Van Velthovens, was applied with slight modifications. Two 3/0 absorbable monofilament (polydioxanone) sutures were used. The first needle is started from bladder neck at 3 o'clock, and terminated in the urethra at 9 o'clock. After completion of the posterior anastomosis, a transurethral catheter is placed. The second sutures' needle is passed from the bladder at 9 o'clock and ended in the urethra at 3 o'clock. The bladder neck and urethra are merged by gentle traction of the anterior and posterior sutures at 3 and 9 o'clock.
interrupted suture for vesico-urethral anastomosis in open radical prostatectomyProcedure or surgery
The technique described by Walsh for interrupted anastomotic suturing was applied with minor modifications. Six 3/0 absorbable monofilament (polydioxanone) sutures were placed at 1, 3, 5, 7, 9 and 11 o'clock to accomplish the vesicourethral anastomosis.
| Study group | Role | What they receive |
|---|---|---|
| Running suture (RS) | Active comparator | Running suture technique for vesico-urethral anastomosis in open radical prostatectomy Receives: Procedure: Running suture for vesico-urethral anastomosis in open radical prostatectomy |
| Interrupted suture (IS) | Active comparator | Interrupted suture technique for vesico-urethral anastomosis in open radical prostatectomy Receives: Procedure: interrupted suture for vesico-urethral anastomosis in open radical prostatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum flow rate (MFR)
Uroflowmetry is a noninvasive test that measures the rate of urine flow over time. Uroflowmetry involves a well-hydrated patient voiding into a uroflowmeter, which in turn generates a "flow curve." The flow curve enables the measurement of the MFR .A value of 15ml/sec or below is deemed to be outside the normal range.
Measured: preoperative and 1,3,6,12 months visits after surgery.
Post-voiding residuel volume (PVR)
PVR is defined as the residual urine volume in the bladder following voiding, as calculated by ultrasound imaging. A volume of 150 cc or above is regarded as pathological.
Measured: preoperative and 1,3,6,12 months visits after surgery.
Urinary function(UF)
Urinary function(UF) and urinary function-related bother: UF measured by the International Prostate Symptom Score [IPSS]) The IPSS is based on the answers to seven questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The total score can therefore range from 0 to 35 . UF-related bother measured by the IPSS quality of life question with a response from 0 to 6.
Measured: preoperative and 1,3,6,12 months visits after surgery.
Continence recovery
Urinary continence recovery defined as patient-reported use of zero pad or one security pad per day.
Measured: preoperative and 1,3,6,12 months visits after surgery.
Secondary outcomes (3)
Surgical parameters
Duration of vesico-urethral anastomosis time
Measured: During the operation
Anastomotic extravasation
Presence of anastomotic extravasation on first cystogram
Measured: Postoperative day 5.
Perioperative complications
Clavien-Dindo scoring system
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start7 Feb 2022
- Primary completion1 Aug 2023
- Study completion16 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer SurgeryStudies 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
- Model description
- The investigators conducted a two-group, parallel-design, pragmatic study of 70 consecutive patients with clinically localised (pT1-pT2) PCa undergoing primary open RP by a well-experienced single surgical team at Dr Lutfi Kirdar City Hospital as a tertiary care institution .The optimal sample size for this study was calculated to be 70 patients (35 patients in each arm) by the power calculation (α = 0.05, β = 0.1, power: 90%) The subjects were randomly assigned to one of two treatment groups using a simple randomization procedure that involved computer-generated random numbers in Microsoft Excel.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kartal City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Utku Can, Kartal City Hospital
- Investigators
- Utku Can, Principal investigator, Kartal Dr Lutfi Kirdar City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06670924
- Sponsor's protocol ID
- kartalcity_ucan_001
- Status last verified
- Oct 2024
- First submitted
- 31 Oct 2024
- Last updated
- 4 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pragmatic Randomized Controlled Trial Comparing the Effects of Suturing Techniques for Vesico-urethral Anastomosis on One-year Voiding Function After Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT06670924
- Acronym / sponsor ID
- kartalcity_ucan_001
- Conditions
- Prostate Cancer Surgery
- Keywords
- prostate cancer, vesicourethral anastomosis, voiding function, suture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Kartal City HospitalUniversity, hospital or other
- Study start
- 7 Feb 2022 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 16 Aug 2024 (actual)
- First posted
- 1 Nov 2024 (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.
Radical prostatectomy (RP) is the most common curative treatment for prostate cancer (PCa).Vesicourethral anastomosis (VUA) is a crucial step and either a conventional interrupted (IS) or a running (RS) suture is employed during radical prostatectomy (RP). Certainly, both RS and IS have advantages and limitations. The metanalysis revealed that potential advantages for RS compared to IS, especially for short-term outcomes such as catheterization time, extravasation rate, and anastomotic suture time. There were no significant differences for long-term outcomes (continence, incidence of vesicourethral anastomotic stenosis). Generally, the exciting evidence suggests that CS should be preferred over IS. However, this should be followed only if it is technically feasible and appropriate regarding the surgical approach. Both techniques seem to be safe and appropriate for the VUA, and the technique should be chosen based on individual experience and preference.
The investigators hypothesized that RS and IS may have different effects on voiding function and flow rate, even if they do not cause an anastomotic stenosis requiring intervention. Furthermore, there is no existing literature that compares RS and IS in terms of voiding function.This article focuses on one year uroflowmetric voiding parameters, urinary function (UF), and UF related bother function, urinary continence recovery as well as other secondary outcomes, including surgical parameters, perioperative morbidity and oncological outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- The investigators conducted a two-group, parallel-design, pragmatic study of 70 consecutive patients with clinically localised (pT1-pT2) PCa undergoing primary open RP by a well-experienced single surgical team at Dr Lutfi Kirdar City Hospital as a tertiary care institution .The optimal sample size for this study was calculated to be 70 patients (35 patients in each arm) by the power calculation (α = 0.05, β = 0.1, power: 90%) The subjects were randomly assigned to one of two treatment groups using a simple randomization procedure that involved computer-generated random numbers in Microsoft Excel.
| Arm | Type | Receives |
|---|---|---|
| Running suture (RS) | Active comparator | Procedure: Running suture for vesico-urethral anastomosis in open radical prostatectomyRunning suture technique for vesico-urethral anastomosis in open radical prostatectomy |
| Interrupted suture (IS) | Active comparator | Procedure: interrupted suture for vesico-urethral anastomosis in open radical prostatectomyInterrupted suture technique for vesico-urethral anastomosis in open radical prostatectomy |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of clinically localised (pT1-pT2) prostate cancer
- must select the open radical prostatectomy procedure as a treatment option.
Key exclusion criteria (2 listed)
- History of acute urinary retention
- History of urethral stricture
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 |
|---|---|---|
| Running suture for vesico-urethral anastomosis in open radical prostatectomyThe surgical technique of the RS followed the description of Van Velthovens, was applied with slight modifications. Two 3/0 absorbable monofilament (polydioxanone) sutures were used. The first needle is started from bladder neck at 3 o'clock, and terminated in the urethra at 9 o'clock. After completion of the posterior anastomosis, a transurethral catheter is placed. The second sutures' needle is passed from the bladder at 9 o'clock and ended in the urethra at 3 o'clock. The bladder neck and urethra are merged by gentle traction of the anterior and posterior sutures at 3 and 9 o'clock. | Procedure or surgery | Running suture (RS) |
| interrupted suture for vesico-urethral anastomosis in open radical prostatectomyThe technique described by Walsh for interrupted anastomotic suturing was applied with minor modifications. Six 3/0 absorbable monofilament (polydioxanone) sutures were placed at 1, 3, 5, 7, 9 and 11 o'clock to accomplish the vesicourethral anastomosis. | Procedure or surgery | Interrupted suture (IS) |
Primary outcome
Maximum flow rate (MFR)
Time frame: preoperative and 1,3,6,12 months visits after surgery.
Uroflowmetry is a noninvasive test that measures the rate of urine flow over time. Uroflowmetry involves a well-hydrated patient voiding into a uroflowmeter, which in turn generates a "flow curve." The flow curve enables the measurement of the MFR .A value of 15ml/sec or below is deemed to be outside the normal range.
Post-voiding residuel volume (PVR)
Time frame: preoperative and 1,3,6,12 months visits after surgery.
PVR is defined as the residual urine volume in the bladder following voiding, as calculated by ultrasound imaging. A volume of 150 cc or above is regarded as pathological.
Urinary function(UF)
Time frame: preoperative and 1,3,6,12 months visits after surgery.
Urinary function(UF) and urinary function-related bother: UF measured by the International Prostate Symptom Score [IPSS]) The IPSS is based on the answers to seven questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The total score can therefore range from 0 to 35 . UF-related bother measured by the IPSS quality of life question with a response from 0 to 6.
Continence recovery
Time frame: preoperative and 1,3,6,12 months visits after surgery.
Urinary continence recovery defined as patient-reported use of zero pad or one security pad per day.
3 secondary outcomes
Surgical parameters
Time frame: During the operation
Anastomotic extravasation
Time frame: Postoperative day 5.
Perioperative complications
Time frame: Through study completion, an average of 1 year
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 4 Nov 2024.
- Individual participant dataSharing planned: No
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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.
Utku Can principal investigator
Kartal Dr Lutfi Kirdar City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Running suture for vesico-urethral anastomosis in open radical prostatectomy and interrupted suture for vesico-urethral anastomosis in open radical prostatectomy in people with Prostate Cancer Surgery, run by Kartal City Hospital at 1 site in Turkey (Türkiye).
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 2 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: finished, as of the sponsor's last update on 4 Nov 2024. 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 Turkey (Türkiye). 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?
Maximum flow rate (MFR) (time frame: preoperative and 1,3,6,12 months visits after surgery.). The study lists 4 primary outcomes in all. 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 4 Nov 2024.