Laparoscopic vs Robotic-Assisted Radical Prostatectomy (NCT03682146) | Clinical Trial Compass
CompletedNot Applicable
Laparoscopic vs Robotic-Assisted Radical Prostatectomy
Germany782 participantsStarted 2014-11
Plain-language summary
This randomized trial was designed to address the lack of high-quality literature comparing robotic-assisted (RARP) and laparoscopic (LRP) radical prostatectomy (RP).
Purpose: The LAP-01 trial compares outcomes between RARP and LRP.
Who can participate
Age range18 Years – 75 Years
SexMALE
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Inclusion criteria
* Histological verified prostate carcinoma (first diagnosis)
* Indication for primary curative radical prostatectomy
* Age ≤ 75 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
Early Continence
Timeframe: 3 months after removal of the urinary catheter