Retzius-sparing Robot-assisted Radical Prostatectomy With "Sandwich" Technique of Total Urethral … (NCT06730243) | Clinical Trial Compass
RecruitingNot Applicable
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
China300 participantsStarted 2023-01-01
Plain-language summary
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.
Who can participate
Age range18 Years – 80 Years
SexMALE
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Inclusion Criteria:
* Histological verified prostate carcinoma (first diagnosis) Indication for primary curative radical prostatectomy Age ≤80 years Patient agrees to randomisation Patient is able to fill in the questionnaires on his own Patient is willing to provide written informed consent
Exclusion Criteria:
* Insufficient knowledge of German Severe cognitive impairment Obesity (BMI \> 35) Current existing severe comorbidities (e.g. liver cirrhosis, second malignancy or relapse of every kind) Tumor stage: T4 Previous malignancy (≤ 3 years before trial participation) Neoadjuvant therapy (hormons) within the last 3 months before participation in the trial Patient is immuno-compromised History of intermittent urinary self-catheterization within the last year Psychological disorders (dementia, chronic depression, psychosis) Any of the following treatments ≤ 3 months before trial participation: surgery of the sigmoid colon, extended haemorrhoid resection, transurethral needle ablation of the prostate (TUNA), osteosynthesis of the pelvis, salvage prostatectomy Patients with chronic urinary infection Dialysis patients Lacking willingness for data storage and handling in the frame of the trial protocol/aims
What they're measuring
1
immediate urinary continence analysis
Timeframe: 1day,1month, 3 months after removal of the urinary cathete
Trial details
NCT IDNCT06730243
SponsorMinistry of Science and Technology of the People´s Republic of China