Prostate CancerNCT06355076
New Urethral Reconstruction in Robot-assisted Laparoscopic Radical Resection
A study testing New urethral reconstruction in people with Prostate Cancer, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
The purpose of this clinical trial is to compare new reconstruction and anastomosis in robot-assisted radical laparoscopic resection It will also understand the possibility of exploring new reconstruction in completely solving patients' postoperative urinary incontinence The main questions it aims to answer are: Is… 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?
- New urethral reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteChina
- Study dates
- 5 Feb 2023to Jun 2026
- 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
- Age ≥ 18 years old, confirmed by puncture pathology as prostate cancer
- The tumor has no extensive distant metastasis, or has reached a resectable state through neoadjuvant chemotherapy and endocrine therapy
- Willing to accept robot assisted laparoscopic radical prostatectomy
Who cannot join
- Tumor metastasis cannot achieve curative effect through surgery
- Concomitant severe cardiovascular and cerebrovascular complications
- Merge severe mental and neurological disorders
- Poor liver and kidney function
- Refusal to accept robot assisted laparoscopic radical prostatectomy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Qilu hospital
Jinan, Shandong, 276600
shouzhen chen, 18560089085, 201900412102@mail.sdu.edu.cn
About this study
Official title: Comparison of New Reconstruction and Anastomosis in Robot-assisted Laparoscopic Radical Resection: a Prospective Randomized Controlled Study
The purpose of this clinical trial is to compare new reconstruction and anastomosis in robot-assisted radical laparoscopic resection It will also understand the possibility of exploring new reconstruction in completely solving patients' postoperative urinary incontinence The main questions it aims to answer are:
Is there a significant improvement in urinary control in patients with new reconstruction compared with patients with anastomosis? The researchers compared the new reconstruction with anastomosis in robot-assisted laparoscopic radical resection to see if the new reconstruction improved urinary incontinence after operation.
Read more
Participants will:
The intervention group adopted the new reconstruction proposed by our team; End-to-end anastomosis was performed in non-intervention group.
Read the detailed description
It is one of the most common malignant tumors in urology, and its incidence rate is the second among male malignant tumors in the world. In recent years, with the economic and social development in China, the incidence rate has increased year by year, which seriously threatens the Radical resection is the current treatment plan. Although radical surgery can prolong the survival time of patients, because of the surgical injury, the incidence of urinary incontinence and sexual function after operation is high, which greatly affects the physiological health, mental health and social function of patients.
In order to solve the above problems, Professor Shi Benkang's team of Urology Department of Qilu Hospital of Shandong University improved the existing urinary tract reconstruction after consulting a large number of related literatures and combining with the new findings of our team's previous anatomical work, which needed to be carried out under Da Vinci Xi surgical system. By continuously suturing the fascia on the surface of levator anal muscle and the posterior dorsal median ridge (MDR) and Dirichlet fascia of the lateral tissue, it achieved the purpose of protecting the apical saccular tube bundle (NVB) and maintaining the stability of the length of vascular and nerve lengthening function in the posterior MDR We found that the postoperative urinary incontinence of patients with new reconstruction technique is obviously better than that of anastomosis, which provides a new idea for improving the postoperative urinary incontinence of RARP patients.
- Conditions
- Prostate Cancer
- Being tested
- New urethral reconstruction
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New urethral reconstructionProcedure or surgery
This kind of reconstruction suture has larger area, higher firmness, better fixation of the position of broken end and prolongation of functional length.
| Study group | Role | What they receive |
|---|---|---|
| New urethral reconstruction arm | Experimental | The experimental group received a new reconstruction technique, in which the levator anus and the dorsal median ridge (MDR) of the lateral striated muscle were sutured to the Dirichlet fascia for continuous suture before anastomosis Receives: Procedure: New urethral reconstruction |
| Traditional bladder urethral anastomosis arm | Active comparator | End to end anastomosis of bladder and urethra Receives: Procedure: New urethral reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery of urinary incontinence
Recovery of urinary incontinence in intervention group and non-intervention group at the first time of catheter extubation, 1 month, 3 months, 6 months and 1 year after catheter extubation
Measured: at the first time of catheter extubation, 1 month, 3 months, 6 months and 1 year after catheter extubation
Secondary outcomes (3)
complication
complications include infection, bleeding, etc.
Measured: at the first time of catheter extubation, 1 month, 3 months, 6 months and 1 year after catheter extubation
PSA
Prostate Specific Antigen
Measured: at the first time of catheter extubation, 1 month, 3 months, 6 months and 1 year after catheter extubation
recurrence
Tumor recurrence
Measured: at the first time of catheter extubation, 1 month, 3 months, 6 months and 1 year after catheter extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start5 Feb 2023
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe sponsor's other registered studies.
- 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 experimental group received a new urethral reconstruction technique, which involves suturing the levator ani muscle with the lateral striated muscle of the urethra, the dorsal median ridge (MDR), and the Di's fascia together for continuous suturing before performing bladder urethral anastomosis. After the reconstruction is completed, the end to end anastomosis of the bladder urethra is performed
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shouzhen Chen, Dr., Study chair, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06355076
- Sponsor's protocol ID
- CSZ03
- Status last verified
- Sep 2023
- First submitted
- 31 Mar 2024
- Last updated
- 9 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ficarra V, Rossanese M, Crestani A, Alario G, Mucciardi G, Isgro A, Giannarini G. Robot-assisted Radical Prostatectomy Using the Novel Urethral Fixation Technique Versus Standard Vesicourethral Anastomosis. Eur Urol. 2021 Apr;79(4):530-536. doi: 10.1016/j.eururo.2021.01.028. Epub 2021 Feb 4.
PubMed 33551295Cui J, Guo H, Li Y, Chen S, Zhu Y, Wang S, Wang Y, Liu X, Wang W, Han J, Chen P, Nie S, Yin G, Shi B. Pelvic Floor Reconstruction After Radical Prostatectomy: A Systematic Review and Meta-analysis of Different Surgical Techniques. Sci Rep. 2017 Jun 2;7(1):2737. doi: 10.1038/s41598-017-02991-8.
PubMed 28578433Rocco B, Gregori A, Stener S, Santoro L, Bozzola A, Galli S, Knez R, Scieri F, Scaburri A, Gaboardi F. Posterior reconstruction of the rhabdosphincter allows a rapid recovery of continence after transperitoneal videolaparoscopic radical prostatectomy. Eur Urol. 2007 Apr;51(4):996-1003. doi: 10.1016/j.eururo.2006.10.014. Epub 2006 Oct 23.
PubMed 17079070Sanda MG, Dunn RL, Michalski J, Sandler HM, Northouse L, Hembroff L, Lin X, Greenfield TK, Litwin MS, Saigal CS, Mahadevan A, Klein E, Kibel A, Pisters LL, Kuban D, Kaplan I, Wood D, Ciezki J, Shah N, Wei JT. Quality of life and satisfaction with outcome among prostate-cancer survivors. N Engl J Med. 2008 Mar 20;358(12):1250-61. doi: 10.1056/NEJMoa074311.
PubMed 18354103Mungovan SF, Carlsson SV, Gass GC, Graham PL, Sandhu JS, Akin O, Scardino PT, Eastham JA, Patel MI. Preoperative exercise interventions to optimize continence outcomes following radical prostatectomy. Nat Rev Urol. 2021 May;18(5):259-281. doi: 10.1038/s41585-021-00445-5. Epub 2021 Apr 8.
PubMed 33833445Moore K, Allen M, Voaklander DC. Pad tests and self-reports of continence in men awaiting radical prostatectomy: establishing baseline norms for males. Neurourol Urodyn. 2004;23(7):623-6. doi: 10.1002/nau.20067.
PubMed 15382185Qi W, Dou M, Xu L, Qu S, Zhu Y, Chen S, Shi B. Robot-assisted radical prostatectomy using a novel urethral reconstruction technique vs standard vesicourethral anastomosis. A retrospective cohort study. World J Urol. 2023 Jan;41(1):51-58. doi: 10.1007/s00345-022-04208-8. Epub 2022 Nov 24.
PubMed 36434138
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of New Reconstruction and Anastomosis in Robot-assisted Laparoscopic Radical Resection: a Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06355076
- Acronym / sponsor ID
- CSZ03
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 5 Feb 2023 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 9 Apr 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.
The purpose of this clinical trial is to compare new reconstruction and anastomosis in robot-assisted radical laparoscopic resection It will also understand the possibility of exploring new reconstruction in completely solving patients' postoperative urinary incontinence The main questions it aims to answer are:
Is there a significant improvement in urinary control in patients with new reconstruction compared with patients with anastomosis? The researchers compared the new reconstruction with anastomosis in robot-assisted laparoscopic radical resection to see if the new reconstruction improved urinary incontinence after operation.
Participants will:
The intervention group adopted the new reconstruction proposed by our team; End-to-end anastomosis was performed in non-intervention group.
Detailed description
It is one of the most common malignant tumors in urology, and its incidence rate is the second among male malignant tumors in the world. In recent years, with the economic and social development in China, the incidence rate has increased year by year, which seriously threatens the Radical resection is the current treatment plan. Although radical surgery can prolong the survival time of patients, because of the surgical injury, the incidence of urinary incontinence and sexual function after operation is high, which greatly affects the physiological health, mental health and social function of patients.
In order to solve the above problems, Professor Shi Benkang's team of Urology Department of Qilu Hospital of Shandong University improved the existing urinary tract reconstruction after consulting a large number of related literatures and combining with the new findings of our team's previous anatomical work, which needed to be carried out under Da Vinci Xi surgical system. By continuously suturing the fascia on the surface of levator anal muscle and the posterior dorsal median ridge (MDR) and Dirichlet fascia of the lateral tissue, it achieved the purpose of protecting the apical saccular tube bundle (NVB) and maintaining the stability of the length of vascular and nerve lengthening function in the posterior MDR We found that the postoperative urinary incontinence of patients with new reconstruction technique is obviously better than that of anastomosis, which provides a new idea for improving the postoperative urinary incontinence of RARP patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The experimental group received a new urethral reconstruction technique, which involves suturing the levator ani muscle with the lateral striated muscle of the urethra, the dorsal median ridge (MDR), and the Di's fascia together for continuous suturing before performing bladder urethral anastomosis. After the reconstruction is completed, the end to end anastomosis of the bladder urethra is performed
| Arm | Type | Receives |
|---|---|---|
| New urethral reconstruction arm | Experimental | Procedure: New urethral reconstructionThe experimental group received a new reconstruction technique, in which the levator anus and the dorsal median ridge (MDR) of the lateral striated muscle were sutured to the Dirichlet fascia for continuous suture before anastomosis |
| Traditional bladder urethral anastomosis arm | Active comparator | Procedure: New urethral reconstructionEnd to end anastomosis of bladder and urethra |
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)
- Age ≥ 18 years old, confirmed by puncture pathology as prostate cancer
- The tumor has no extensive distant metastasis, or has reached a resectable state through neoadjuvant chemotherapy and endocrine therapy
- Willing to accept robot assisted laparoscopic radical prostatectomy
Key exclusion criteria (5 listed)
- Tumor metastasis cannot achieve curative effect through surgery
- Concomitant severe cardiovascular and cerebrovascular complications
- Merge severe mental and neurological disorders
- Poor liver and kidney function
- Refusal to accept robot assisted laparoscopic 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 |
|---|---|---|
| New urethral reconstructionThis kind of reconstruction suture has larger area, higher firmness, better fixation of the position of broken end and prolongation of functional length. | Procedure or surgery | New urethral reconstruction arm, Traditional bladder urethral anastomosis arm |
Primary outcome
Recovery of urinary incontinence
Time frame: at the first time of catheter extubation, 1 month, 3 months, 6 months and 1 year after catheter extubation
Recovery of urinary incontinence in intervention group and non-intervention group at the first time of catheter extubation, 1 month, 3 months, 6 months and 1 year after catheter extubation
3 secondary outcomes
complication
Time frame: at the first time of catheter extubation, 1 month, 3 months, 6 months and 1 year after catheter extubation
PSA
Time frame: at the first time of catheter extubation, 1 month, 3 months, 6 months and 1 year after catheter extubation
recurrence
Time frame: at the first time of catheter extubation, 1 month, 3 months, 6 months and 1 year after catheter extubation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
- Background: PubMed 33551295Ficarra V, Rossanese M, Crestani A, Alario G, Mucciardi G, Isgro A, Giannarini G. Robot-assisted Radical Prostatectomy Using the Novel Urethral Fixation Technique Versus Standard Vesicourethral Anastomosis. Eur Urol. 2021 Apr;79(4):530-536. doi: 10.1016/j.eururo.2021.01.028. Epub 2021 Feb 4.
- Background: PubMed 28578433Cui J, Guo H, Li Y, Chen S, Zhu Y, Wang S, Wang Y, Liu X, Wang W, Han J, Chen P, Nie S, Yin G, Shi B. Pelvic Floor Reconstruction After Radical Prostatectomy: A Systematic Review and Meta-analysis of Different Surgical Techniques. Sci Rep. 2017 Jun 2;7(1):2737. doi: 10.1038/s41598-017-02991-8.
- Background: PubMed 17079070Rocco B, Gregori A, Stener S, Santoro L, Bozzola A, Galli S, Knez R, Scieri F, Scaburri A, Gaboardi F. Posterior reconstruction of the rhabdosphincter allows a rapid recovery of continence after transperitoneal videolaparoscopic radical prostatectomy. Eur Urol. 2007 Apr;51(4):996-1003. doi: 10.1016/j.eururo.2006.10.014. Epub 2006 Oct 23.
- Background: PubMed 18354103Sanda MG, Dunn RL, Michalski J, Sandler HM, Northouse L, Hembroff L, Lin X, Greenfield TK, Litwin MS, Saigal CS, Mahadevan A, Klein E, Kibel A, Pisters LL, Kuban D, Kaplan I, Wood D, Ciezki J, Shah N, Wei JT. Quality of life and satisfaction with outcome among prostate-cancer survivors. N Engl J Med. 2008 Mar 20;358(12):1250-61. doi: 10.1056/NEJMoa074311.
- Background: PubMed 33833445Mungovan SF, Carlsson SV, Gass GC, Graham PL, Sandhu JS, Akin O, Scardino PT, Eastham JA, Patel MI. Preoperative exercise interventions to optimize continence outcomes following radical prostatectomy. Nat Rev Urol. 2021 May;18(5):259-281. doi: 10.1038/s41585-021-00445-5. Epub 2021 Apr 8.
- Results publication: PubMed 15382185Moore K, Allen M, Voaklander DC. Pad tests and self-reports of continence in men awaiting radical prostatectomy: establishing baseline norms for males. Neurourol Urodyn. 2004;23(7):623-6. doi: 10.1002/nau.20067.
- Results publication: PubMed 36434138Qi W, Dou M, Xu L, Qu S, Zhu Y, Chen S, Shi B. Robot-assisted radical prostatectomy using a novel urethral reconstruction technique vs standard vesicourethral anastomosis. A retrospective cohort study. World J Urol. 2023 Jan;41(1):51-58. doi: 10.1007/s00345-022-04208-8. Epub 2022 Nov 24.
Related trials for Prostate Cancer
Active, not recruitingPhase 2/3
Veterans Affairs Seamless Phase II/III Randomized Trial of STAndard Systemic theRapy With or Without PET-directed Local Therapy for Oligometastatic pRosTate Cancer
Prostate Cancer, Oligometastasis
Not yet recruiting
Mind-Body Interventions for the Improvement of Quality of Life, Stress, and Sleep Quality Among Survivors of Breast, Prostate, Endometrial, or Colorectal Cancer
Breast Cancer Stage I, Colorectal Cancer
RecruitingPhase 3
Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003)
Prostate Cancer Metastatic
Active, not recruitingObservational study
Spatial Needle Placement Strategies and Pathological Concordance in Prostate Biopsy: A National Multicenter Retrospective Cohort Study
Prostate Cancer, Prostatic Neoplasms
Active, not recruitingPhase 2
177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu-J591) and Ketoconazole in Patients With Prostate Cancer
Prostate Cancer
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.
Shouzhen Chen, Dr. study chair
Qilu Hospital of Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New urethral reconstruction in people with Prostate Cancer, run by Qilu Hospital of Shandong University 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 3 inclusion and 5 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 9 Apr 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. 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?
Contact Shouzhen Chen, Dr. (18560089085, chensz@mail.sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recovery of urinary incontinence (time frame: at the first time of catheter extubation, 1 month, 3 months, 6 months and 1 year after catheter extubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06355076, which also lists 7 linked publications.
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 9 Apr 2024.