NCT01577836

Medico-economic Comparison of Robot-assisted Radical Prostatectomy Versus Radical Prostatectomy Via Laparotomy

Medico-economic Comparison of Robot-assisted Radical Prostatectomy Using the da Vinci System Versus Radical Prostatectomy Via Laparotomy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Centre Hospitalier Universitaire de Nīmes · Academic / Other
• Sex: Male
• Age: 45 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The main objective of the study is to estimate and compare the overall cost of care of patients over 60 months of follow-up between two groups: (1) patients undergoing robot-assisted radical prostatectomy using the Da Vinci system versus (2) patients undergoing robot-assisted radical prostatectomy via laparotomy. The time horizon of the main objective changes to 60 months (due to the opportunity to access patient care consumption from the National Health Data System).

Detailed description

The secondary objectives of this research are to compare the following between the two groups: * The actual cost of the surgical prostatectomy. * Erectile function at 0, 1, 6, 12 and 24 * Oncological results at 1, 6, 12 and 24 months. * Functional results at 0, 1, 6, 12 and 24 months. * Quality of life at 0, 1, 6, 12 and 24 months. * Complication rates at 1 and 24 months.

Conditions

• Prostatic Neoplasms

Interventions

Type	Name	Description
PROCEDURE	Robot-assisted radical prostatectomy	Transperitoneal robot-assisted radical prostatectomy technique with the Da Vinci S
PROCEDURE	Radical prostatectomy via laparotomy	Classic radical prostatectomy via open retropubic approach

Timeline

• Start date: 2012-11-26
• Primary completion: 2018-06-04
• Completion: 2021-03-22
• First posted: 2012-04-16
• Last updated: 2025-12-12

Locations

3 sites across 1 country: France