Enhanced Recovery Program After a Robotic-assisted Surgery (RAAC) of Radical Prostatectomy. PROSTA-RAAC

Not Applicable

Completed

• Conditions: Quality of Life; Prostate Cancer; Recovery Programm
• Interventions: Behavioral: Follow-up patient program

• Registration Number: NCT05172986
• Lead Sponsor: Elsan

Brief Summary

There are few published data on the benefit of Enhanced recovery program in radical prostatectomy in the management of localized prostate cancer. All the studies available on the subject are retrospective (1-3).

This randomized comparative study is proposed in order to compare in a homogeneous population (place and time) the interest of RAAC specifically in this surgery.

Detailed Description

The implementation of RAAC programs in healthcare establishments would improve the quality and safety of patient care (functional development and rapid convalescence of patients and reduction in postoperative morbidity through active prevention of perioperative complications) and optimization of care costs for health establishments and for health insurance (reduction in length of stay and convalescence, reduction in postoperative complications). Its implementation requires a strong involvement of all the teams and a transversal and multidisciplinary coordination, specifically dedicated to one type of intervention. This approach must therefore show its effectiveness by specialty and then by pathology within the same specialty.

There are few published data on the benefit of RAAC in radical prostatectomy in the management of localized prostate cancer. All the studies available on the subject are retrospective (1-3).

This randomized comparative study is proposed in order to compare in a homogeneous population (place and time) the interest of RAAC specifically in this surgery.

Study Timeline

• Study Start: 2021-10-27
• Study First Submitted: 2021-12-21
• Study First Submitted QC: 2021-12-21
• Study First Posted: 2021-12-29
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-03
• Last Update Posted: 2024-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 135

Inclusion Criteria

• Male over 40 and under 75
• Patient scheduled for a robot assisted radical prostatectomy within the center
• Affiliation to a social security scheme or beneficiary of such a scheme
• Patient having signed the free and informed consent

Exclusion Criteria

• Minor, age ≤ 40 years or ≥ 75 years
• ASA 4 or more
• Severe or poorly balanced associated conditions
• Covid + declared in the previous 3 months
• Refusal to participate in the study
• Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RAAC (Program Arm)	Follow-up patient program	Patient under RAAC Program

Primary Outcome Measures

Name	Time	Method
postoperative stay of RAAC-type treatment	5 days	To assess the length of postoperative stay of RAAC-type treatment compared to standard treatment, during a robotic-assisted radical prostatectomy.

Trial Locations

Locations (1)

Clinique Saint Augustin; 🇫🇷 Bordeaux, Nouvelle Aquitaine, France