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

E

Elsan

Status

Completed

Conditions

Quality of Life
Prostate Cancer
Recovery Programm

Treatments

Behavioral: Follow-up patient program

Study type

Interventional

Funder types

Other

Identifiers

NCT05172986
2020-A03292-37

Details and patient eligibility

About

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.

Full 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.

Enrollment

135 patients

Sex

Male

Ages

40 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

135 participants in 2 patient groups

RAAC (Program Arm)
Experimental group
Description:
Patient under RAAC Program
Treatment:
Behavioral: Follow-up patient program
Standard Arm
No Intervention group
Description:
Standard patient procedure

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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