Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
MALE
NCT06730243

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

Led by Ministry of Science and Technology of the People´s Republic of China · Updated on 2024-12-12

300

Participants Needed

1

Research Sites

104 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 80Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed prostate cancer requiring primary curative radical prostatectomy
  • Age 80 years or younger
  • Agree to randomization
  • Able to complete questionnaires independently
  • Willing to provide written informed consent
Not Eligible

You will not qualify if you...

  • Insufficient German language skills
  • Severe cognitive impairment
  • Obesity with BMI greater than 35
  • Severe existing comorbidities such as liver cirrhosis or second malignancy
  • Tumor stage T4
  • Previous malignancy within 3 years before participation
  • Neoadjuvant hormone therapy within 3 months before participation
  • Immunocompromised status
  • History of intermittent urinary self-catheterization within the past year
  • Psychological disorders including dementia, chronic depression, or psychosis
  • Undergoing certain surgeries within 3 months before participation (sigmoid colon surgery, extended hemorrhoid resection, transurethral needle ablation of the prostate, pelvic osteosynthesis, salvage prostatectomy)
  • Chronic urinary infection
  • Dialysis patients
  • Unwillingness to allow data storage and handling per trial protocol

AI-Screening

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Trial Site Locations

Total: 1 location

1

National Cancer Center

Beijing, Beijing Municipality, China, 100021

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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