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Improved Robotic-Assisted Radical Prostatectomy for Locally Advanced Prostate Cancer: Bladder Suspension and Preliminary Outcomes

Improved Robotic-Assisted Radical Prostatectomy for Locally Advanced Prostate Cancer: Bladder Suspension and Preliminary Outcomes

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06977906
Enrollment
300
Registered
2025-05-18
Start date
2024-01-01
Completion date
2027-01-01
Last updated
2025-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Suspension, Locally Advanced Prostate Cancer, Robotic-Assisted Radical Prostatectomy

Keywords

Robotic-Assisted Radical Prostatectomy, Locally Advanced Prostate Cancer, Bladder Suspension

Brief summary

This study is a prospective, single-center clinical trial. It aims to establish an improved robotic-assisted radical prostatectomy for treating locally advanced prostate cancer. The technique evaluates the impact of preserving the anterior peritoneum of the bladder on postoperative bladder descent and urinary control recovery. A retrospective analysis compares this modified approach with traditional anterior approach surgery, assessing differences in oncological outcomes, early functional recovery, and postoperative complication rates. The goal is to provide new theoretical foundations and technical support for the prevention and treatment of postoperative urinary incontinence.

Interventions

PROCEDUREconventional Robotic-assisted radical prostatectomy group

Robotic-assisted radical prostatectomy uses a standard anterior approach with transabdominal or extraperitoneal access. After establishing pneumoperitoneum, the Retzius space is dissected to expose the prostate. The deep dorsal venous complex is ligated to control bleeding, and the bladder neck is carefully dissected while preserving the ureters. Seminal vesicles, vas deferens, and neurovascular bundles are selectively preserved based on tumor characteristics. A tension-free anastomosis of the bladder and urethra is performed using absorbable sutures. Lymph node dissection is done if necessary. The robotic system ensures precise dissection, hemostasis, and suturing, optimizing oncological control while preserving urinary continence and sexual function with reduced bleeding and complications.

PROCEDUREImproved Robotic-assisted radical prostatectomy group

The procedure is performed in a head-down, feet-up supine position with an abdominal or extraperitoneal approach. The right peritoneum is opened along the right external iliac vein to clear the obturator nerve, vessels, and lymph nodes. The external and internal iliac lymph nodes are also cleared. The right pelvic fascia is incised to remove prostate fat while preserving the bladder's anterior wall peritoneum. The same approach is used on the left side. The peritoneum is retracted to clear anterior prostate fat, and the deep venous complex is ligated to expose the prostate. Prostatectomy is performed, followed by urethra and bladder anastomosis, and peritoneal suturing with drainage tube placement.

Sponsors

First Affiliated Hospital of Fujian Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Healthy volunteers
No

Inclusion criteria

1. prostate biopsy and clinical confirmation of high-risk prostate cancer (PSA \> 20 ng/mL, Gleason score ≥ 8, or cT stage ≥ T2c) followed by robotic-assisted radical prostatectomy 2. multiparametric MRI (mpMRI) with a 3.0 T scanner for prostate or pelvic scans performed within 30 days before the operation at our center 3. Eastern Cooperative Oncology Group (ECOG) performance status score between 0 and 1 4. Complete clinical and prostate biopsy pathological data. 5. General health is good, with no infections, autoimmune diseases, hematologic disorders, or other malignancies.

Exclusion criteria

1. Presence of surgical contraindications. 2. refusal of enhanced mpMRI imaging.

Design outcomes

Primary

MeasureTime frameDescription
rate of continence1 week, 1 month and 3 month after postoperative removal of the urinary catheterTime Frame:1 week, 1 month and 3 month after postoperative removal of the urinary catheter
The degree of bladder descent1 month after operationTime Frame:1 month after operation

Countries

China

Contacts

Primary ContactXu Ning, Dr.
drxun@fjmu.edu.cn+8613235907575

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026