NCT03682146

Laparoscopic vs Robotic-Assisted Radical Prostatectomy

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 782 (actual)
• Sponsor: University of Leipzig · Academic / Other
• Sex: Male
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
PROCEDURE	Prostatectomy	Comparison of robotic-assisted and conventional laparoscopic radical prostatectomy

Timeline

• Start date: 2014-11-01
• Primary completion: 2021-05-01
• Completion: 2021-12-01
• First posted: 2018-09-24
• Last updated: 2023-11-30

Locations

4 sites across 1 country: Germany