Retzius-sparing Robot-assisted Radical Prostatectomy With "Sandwich" Technique of Total Urethral ReconstructionRS-RARP-SNCT06730243
Retzius-sparing Robot-assisted Radical Prostatectomy With "Sandwich" Technique of Total Urethral Reconstruction Versus Standard Robot-Assisted Radical Prostatectomy Versus Laparoscopic Radical Prostatectomy Surgery: A Comparative Prospective Study of 300 Patients
A study testing Retzius-sparing robot-assisted radical prostatectomy and "Sandwich" Technique of Total Urethral Reconstruction, Standard Robot-Assisted Radical Prostatectomy and Laparoscopic Radical Prostatectomy in people with Retzius-sparing Robot-assisted Radical Prostatectomy With "Sandwich" Technique of Total Urethral Reconstruction, run by Ministry of Science and Technology of the People´s Republic of China at 1 site in China.
Trial summary
To evaluate the impact of Retzius-sparing robot-assisted radical prostatectomy with "Sandwich" Technique of Total Urethral Reconstruction on early recovery of urinary continence (UC) compared to the conventional approach (anterior approach) and Laparoscopic Radical Prostatectomy for the treatment of clinically… Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Retzius-sparing Robot-assisted Radical Prostatectomy With "Sandwich" Technique of Total Urethral Reconstruction
- What is being tested?
- Retzius-sparing robot-assisted radical prostatectomy and "Sandwich" Technique of Total Urethral Reconstruction, Standard Robot-Assisted Radical Prostatectomy and Laparoscopic Radical Prostatectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 1 Jan 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Histological verified prostate carcinoma (first diagnosis) Indication for primary curative radical prostatectomy Age ≤80 years Patient agrees to randomisation Patient is able to fill in the questionnaires on his own Patient is willing to provide written informed consent
Who cannot join
- Insufficient knowledge of German Severe cognitive impairment Obesity (BMI > 35) Current existing severe comorbidities (e.g. liver cirrhosis, second malignancy or relapse of every kind) Tumor stage: T4 Previous malignancy (≤ 3 years before trial participation) Neoadjuvant therapy (hormons) within the last 3 months before participation in the trial Patient is immuno-compromised History of intermittent urinary self-catheterization within the last year Psychological disorders (dementia, chronic depression, psychosis) Any of the following treatments ≤ 3 months before trial participation: surgery of the sigmoid colon, extended haemorrhoid resection, transurethral needle ablation of the prostate (TUNA), osteosynthesis of the pelvis, salvage prostatectomy Patients with chronic urinary infection Dialysis patients Lacking willingness for data storage and handling in the frame of the trial protocol/aims
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
National Cancer Center
Beijing, Beijing Municipality, 100021
dong chen, +8618613398116, cd900103@163.com
Nianzeng Xing
About this study
Official title: To Evaluate the Impact of Retzius-sparing Robot-assisted Radical Prostatectomy With "Sandwich" Technique of Total Urethral Reconstruction on Early Recovery of Urinary Continence (UC) Compared to the Conventional Approach (Anterior Approach) and Laparoscopic Radical Prostatectomy for the Treatment of Clinically Localized Prostate Cancer (PCa).
To evaluate the impact of Retzius-sparing robot-assisted radical prostatectomy with "Sandwich" Technique of Total Urethral Reconstruction on early recovery of urinary continence (UC) compared to the conventional approach (anterior approach) and Laparoscopic Radical Prostatectomy for the treatment of clinically localized prostate cancer (PCa).Purpose: The trial compares outcomes between three groups.
Read the detailed description
300 consecutive patients with clinically localized PCa underwent RS-RARP-S (Retzius-sparing robot-assisted radical prostatectomy and "Sandwich" Technique of Total Urethral Reconstruction) or S-RARP (Standard RARP) or LRP by 6 experienced surgeons regardless of clinicopathological features. The indication for one technique or the others were surgeon preference; one surgeon exclusively performed RS-RARP-S( did not exclude high risk cases or those with apical and anterior tumors), two surgeons performed S-RARP, and three surgeons exclusively performed LRP. The investigation include an extensive evaluation of clinical, oncological, functional and quality of life related data by means of validated patient-reported outcome measures.
The primary outcome is early recovery of urinary continence compared to the conventional approach.
- Being tested
- Retzius-sparing robot-assisted radical prostatectomy and "Sandwich" Technique of Total Urethral Reconstruction, Standard Robot-Assisted Radical Prostatectomy, Laparoscopic Radical Prostatectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retzius-sparing robot-assisted radical prostatectomy and "Sandwich" Technique of Total Urethral ReconstructionProcedure or surgery
Retzius-sparing robot-assisted radical prostatectomy and "Sandwich" Technique of Total Urethral Reconstruction
Standard Robot-Assisted Radical ProstatectomyProcedure or surgery
Standard Robot-Assisted Radical Prostatectomy
Laparoscopic Radical ProstatectomyProcedure or surgery
Laparoscopic Radical Prostatectomy
| Study group | Role | What they receive |
|---|---|---|
| RS-RARP-S | Experimental | Retzius-sparing robot-assisted radical prostatectomy and "Sandwich" Technique of Total Urethral Reconstruction Receives: Procedure: Retzius-sparing robot-assisted radical prostatectomy and "Sandwich" Technique of Total Urethral Reconstruction |
| S-RARP | Experimental | Standard RARP Receives: Procedure: Standard Robot-Assisted Radical Prostatectomy |
| LRP | Sham comparator | Laparoscopic Radical Prostatectomy Receives: Procedure: Laparoscopic Radical Prostatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
immediate urinary continence analysis
Primary outcome was UC (defined as 0 pads/one security liner per day) after catheter removal
Measured: 1day，1month, 3 months after removal of the urinary cathete
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2024
- Study start1 Jan 2023
- Primary completion10 Dec 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retzius-sparing Robot-assisted Radical Prostatectomy With "Sandwich" Technique of Total Urethral ReconstructionStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ministry of Science and Technology of the People´s Republic of China
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Xing Nianzeng, Ministry of Science and Technology of the People´s Republic of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06730243
- Sponsor's protocol ID
- 24/048-4328
- Acronym
- RS-RARP-S
- Status last verified
- Dec 2024
- First submitted
- 8 Dec 2024
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- 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 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Impact of Retzius-sparing Robot-assisted Radical Prostatectomy With "Sandwich" Technique of Total Urethral Reconstruction on Early Recovery of Urinary Continence (UC) Compared to the Conventional Approach (Anterior Approach) and Laparoscopic Radical Prostatectomy for the Treatment of Clinically Localized Prostate Cancer (PCa).
- ClinicalTrials.gov ID
- NCT06730243
- Acronym / sponsor ID
- RS-RARP-S / 24/048-4328
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Ministry of Science and Technology of the People´s Republic of ChinaOther government
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 10 Dec 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 12 Dec 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.
To evaluate the impact of Retzius-sparing robot-assisted radical prostatectomy with "Sandwich" Technique of Total Urethral Reconstruction on early recovery of urinary continence (UC) compared to the conventional approach (anterior approach) and Laparoscopic Radical Prostatectomy for the treatment of clinically localized prostate cancer (PCa).Purpose: The trial compares outcomes between three groups.
Detailed description
300 consecutive patients with clinically localized PCa underwent RS-RARP-S (Retzius-sparing robot-assisted radical prostatectomy and "Sandwich" Technique of Total Urethral Reconstruction) or S-RARP (Standard RARP) or LRP by 6 experienced surgeons regardless of clinicopathological features. The indication for one technique or the others were surgeon preference; one surgeon exclusively performed RS-RARP-S( did not exclude high risk cases or those with apical and anterior tumors), two surgeons performed S-RARP, and three surgeons exclusively performed LRP. The investigation include an extensive evaluation of clinical, oncological, functional and quality of life related data by means of validated patient-reported outcome measures.
The primary outcome is early recovery of urinary continence compared to the conventional approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RS-RARP-S | Experimental | Procedure: Retzius-sparing robot-assisted radical prostatectomy and "Sandwich" Technique of Total Urethral ReconstructionRetzius-sparing robot-assisted radical prostatectomy and "Sandwich" Technique of Total Urethral Reconstruction |
| S-RARP | Experimental | Procedure: Standard Robot-Assisted Radical ProstatectomyStandard RARP |
| LRP | Sham comparator | Procedure: Laparoscopic Radical ProstatectomyLaparoscopic Radical Prostatectomy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Histological verified prostate carcinoma (first diagnosis) Indication for primary curative radical prostatectomy Age ≤80 years Patient agrees to randomisation Patient is able to fill in the questionnaires on his own Patient is willing to provide written informed consent
Key exclusion criteria (1 listed)
- Insufficient knowledge of German Severe cognitive impairment Obesity (BMI > 35) Current existing severe comorbidities (e.g. liver cirrhosis, second malignancy or relapse of every kind) Tumor stage: T4 Previous malignancy (≤ 3 years before trial participation) Neoadjuvant therapy (hormons) within the last 3 months before participation in the trial Patient is immuno-compromised History of intermittent urinary self-catheterization within the last year Psychological disorders (dementia, chronic depression, psychosis) Any of the following treatments ≤ 3 months before trial participation: surgery of the sigmoid colon, extended haemorrhoid resection, transurethral needle ablation of the prostate (TUNA), osteosynthesis of the pelvis, salvage prostatectomy Patients with chronic urinary infection Dialysis patients Lacking willingness for data storage and handling in the frame of the trial protocol/aims
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 |
|---|---|---|
| Retzius-sparing robot-assisted radical prostatectomy and "Sandwich" Technique of Total Urethral ReconstructionRetzius-sparing robot-assisted radical prostatectomy and "Sandwich" Technique of Total Urethral Reconstruction | Procedure or surgery | RS-RARP-S |
| Standard Robot-Assisted Radical ProstatectomyStandard Robot-Assisted Radical Prostatectomy | Procedure or surgery | S-RARP |
| Laparoscopic Radical ProstatectomyLaparoscopic Radical Prostatectomy | Procedure or surgery | LRP |
Primary outcome
immediate urinary continence analysis
Time frame: 1day，1month, 3 months after removal of the urinary cathete
Primary outcome was UC (defined as 0 pads/one security liner per day) after catheter removal
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Retzius-sparing robot-assisted radical prostatectomy and "Sandwich" Technique of Total Urethral Reconstruction, Standard Robot-Assisted Radical Prostatectomy and Laparoscopic Radical Prostatectomy in people with Retzius-sparing Robot-assisted Radical Prostatectomy With "Sandwich" Technique of Total Urethral Reconstruction, run by Ministry of Science and Technology of the People´s Republic of China at 1 site in China.
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 1 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: looking for participants now, as of the sponsor's last update on 12 Dec 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 China. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
immediate urinary continence analysis (time frame: 1day，1month, 3 months after removal of the urinary cathete). 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 12 Dec 2024.