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

Prostate Cancer Clinical Trial

— PROSTA-RAAC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05172986
• Other study ID #: 2020-A03292-37
• Status: Completed
• Phase: N/A
• Start date: October 27, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2024
• Source: Elsan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Quality of Life

Intervention

Behavioral:
• Follow-up patient program
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.

Locations

Country	Name	City	State
France	Clinique Saint Augustin	Bordeaux	Nouvelle Aquitaine

Sponsors (1)

Lead Sponsor	Collaborator
Elsan

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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