NCT03550040

3D Versus Robot Assisted Laparoscopic Prostatectomy.

3D Versus Robot Assisted Laparoscopic Prostatectomy. A Prospective Randomized Non-inferiority Study.

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 155 (actual)
• Sponsor: Tampere University Hospital · Academic / Other
• Sex: Male
• Age: 34 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

A randomized, prospective study to compare the direct and indirect costs, functional and oncologic results of 3D laparoscopic and robot assisted radical prostatectomy procedures.

Detailed description

The direct and indirect costs, functional and oncologic results of robot assisted radical prostatectomy (RALP) are compared to those of 3D laparoscopic radical prostatectomy. The hypothesis of the study is that the functional and oncologic results of the two operative methods are equal, but the direct costs of RAPL are significantly higher. A randomized, prospective non-inferiority study will will enroll 280 patients randomized 1:1 to both operative approaches to test this hypothesis. The primary functional outcome measure is the proportion of patients with complete urinary continence (no protective pad use) at 12 months post operatively. Secondary functional outcome measure is the preservation erectile function at 12 months post operatively. Oncologic outcome measures are the proportion of patients with undetectable post operative prostate specific antigen levels and positive surgical margins at pathological examination. The direct and indirect costs of both operative approaches are recorded.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
PROCEDURE	Radical prostatectomy	Surgical removal of the prostate

Timeline

• Start date: 2018-05-31
• Primary completion: 2021-07-30
• Completion: 2022-07-30
• First posted: 2018-06-08
• Last updated: 2023-11-24

Locations

1 site across 1 country: Finland