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Clinical Trials/NCT05172986
NCT05172986
Completed
Not Applicable

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

Elsan1 site in 1 country135 target enrollmentOctober 27, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prostate Cancer
Sponsor
Elsan
Enrollment
135
Locations
1
Primary Endpoint
postoperative stay of RAAC-type treatment
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 27, 2021
End Date
December 31, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Sponsor
Elsan
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

postoperative stay of RAAC-type treatment

Time Frame: 5 days

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

Study Sites (1)

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