Laparoscopic vs Robotic-Assisted Radical Prostatectomy

A Multicenter Randomized Study to Investigate the Outcomes of Laparoscopic and Robotic-assisted Radical Prostatectomy

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.

LAP-01 is the first multicenter, prospective randomized, patient-blinded controlled trial comparing robotic-assisted and conventional laparoscopic radical prostatectomy.

The investigation include an extensive evaluation of clinical, oncological, functional and quality of life related data by means of validated patient-reported outcome measures.

The primary outcome is the assessment of time to continence restoration at 3 months. This is evaluated by an assessment of a pad diary completed daily by each patient from the time of catheter removal until restoration of continence. Secondary endpoints include continence and erectile function, as well as quality of life (EORTC-QLQ-C30, EORTC-QLQ-PR25), patient satisfaction and Hospital Anxiety and Depression Scale (HADS) at 1, 3, 6 and 12 months after surgery in addition to oncological outcomes up to 3 years follow-up.

With 782 enrolled patients it is the largest trial carried out till date on this topic.

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