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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05172986
Acronym
PROSTA-RAAC
Enrollment
135
Registered
2021-12-29
Start date
2021-10-27
Completion date
2023-12-31
Last updated
2024-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer, Quality of Life, Recovery Programm

Keywords

Robotic assisted

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.

Interventions

BEHAVIORALFollow-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.

Sponsors

Elsan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
40 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
postoperative stay of RAAC-type treatment5 daysTo assess the length of postoperative stay of RAAC-type treatment compared to standard treatment, during a robotic-assisted radical prostatectomy.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026