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Completed

NCT Number: NCT05172986

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

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.

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Key information

Age range

40 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Clinique Saint Augustin

Bordeaux, New Aquitaine, 33200, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Elsan

Other

Registry information

Acronym: PROSTA-RAAC

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Dec 29, 2021
Registry last updated
Jan 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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