RecruitingNot ApplicableNCT06977906

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


Sponsor

First Affiliated Hospital of Fujian Medical University

Enrollment

300 participants

Start Date

Jan 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALE

Plain Language Summary

Simplified for easier understanding

This study is evaluating an improved approach to robotic-assisted surgery for men with high-risk prostate cancer. Researchers are collecting detailed imaging and surgical data to understand how to make robotic prostate removal more precise and effective for locally advanced cases. **You may be eligible if...** - You have been diagnosed with high-risk prostate cancer (PSA above 20, Gleason score 8 or higher, or clinical stage T2c or higher) - You are scheduled for robotic-assisted prostate removal surgery - You have had an MRI of the prostate or pelvis within 30 days before surgery - You are in good general health with no active infections or other cancers - You have an ECOG performance status of 0 or 1 (able to carry out normal activity) **You may NOT be eligible if...** - You have surgical contraindications - You have refused enhanced MRI imaging Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


Locations(1)

first hospital affiliated of Fujian medical university

Fuzhou, Fujian, China

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NCT06977906


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