New method for urethral reconstruction during prostate cancer surgery
Comparison of New Reconstruction and Anastomosis in Robot-assisted Laparoscopic Radical Resection: a Prospective Randomized Controlled Study
This study is testing a new way to rebuild the urethra during prostate cancer surgery to see if it helps men have better control over their urine after the operation compared to the standard method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 94 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Qilu Hospital of Shandong University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Jinan, Shandong) |
| Trial ID | NCT06355076 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare a new urethral reconstruction technique with traditional anastomosis during robot-assisted laparoscopic radical prostatectomy for prostate cancer. The study focuses on assessing the effectiveness of the new reconstruction in reducing postoperative urinary incontinence. Participants will be divided into two groups: one receiving the new reconstruction and the other undergoing standard anastomosis. The trial seeks to determine if the new method leads to significantly better urinary control post-surgery.
Who should consider this trial
Good fit: Ideal candidates are adult males aged 18 and older diagnosed with prostate cancer who are eligible for robot-assisted laparoscopic radical prostatectomy.
Not a fit: Patients with extensive tumor metastasis, severe cardiovascular or neurological disorders, or those unwilling to undergo the surgical procedure may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve urinary control and quality of life for patients undergoing prostate cancer surgery.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving postoperative outcomes in prostate cancer surgeries.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * 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 Exclusion criteria: * 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
Where this trial is running
Jinan, Shandong
- Qilu hospital — Jinan, Shandong, China (Recruiting)
Study contacts
- Study coordinator: Shouzhen Chen, Dr.
- Email: chensz@mail.sdu.edu.cn
- Phone: 18560089085
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.