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

NCT05172986 | Completed

• 1 other identifier: 2020-A03292-37
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer; Quality of Life; Recovery Programm

Keywords

Robotic assisted

Outcome Measures

Primary Outcomes (1)

• postoperative stay of RAAC-type treatment

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

  5 days

Study Arms (2)

RAAC (Program Arm)

EXPERIMENTAL

Patient under RAAC Program

Behavioral: Follow-up patient program

Standard Arm

NO INTERVENTION

Standard patient procedure

Interventions

Follow-up patient program BEHAVIORAL

An additional paramedical visit will be carried out before the surgery. The interview is carried out by the healthcare team. An organization within the service has been set up so that a nurse can be totally seconded for the RAAC mission. The consultation lasts 30 to 45 minutes.

RAAC (Program Arm)

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Elsan: lead

Study Sites (1)

Clinique Saint Augustin

Bordeaux, Nouvelle-Aquitaine, 33200, France

Location

Related Publications (1)

• Pierquet G, Prevost E, Lopez L, Gaston R, Rouffilange J, Riviere J, Roche JB, Vuong N, Genty A, Hoepffner JL, Asimakopoulos AD, Piechaud PT. Enhanced recovery after surgery protocol does not reduce the length of postoperative hospitalization after robot-assisted radical prostatectomy. Outcomes from the first randomized controlled trial: the (PROSTA-RAAC) study. World J Urol. 2025 Nov 15;43(1):699. doi: 10.1007/s00345-025-06078-2.

  PMID: 41240114 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2021
• First Posted: December 29, 2021
• Study Start: October 27, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: January 5, 2024

Record last verified: 2024-01

Locations

FR (1)