Clincosm LogoSign in Get a demo

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

Sponsor
Elsan (Other)
Overall Status
Recruiting
CT.gov ID
NCT05172986
Collaborator
(none)
140
Enrollment
1
Location
2
Arms
8.9
Anticipated Duration (Months)
15.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Follow-up patient program
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
140 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Enhanced Recovery Program After a Robotic-assisted Surgery (RAAC) of Radical Prostatectomy. PROSTA-RAAC
Actual Study Start Date :
Oct 1, 2021
Anticipated Primary Completion Date :
Jun 30, 2022
Anticipated Study Completion Date :
Jun 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: RAAC (Program Arm)

Patient under RAAC Program

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.
No Intervention: Standard Arm

Standard patient procedure

Outcome Measures

Primary Outcome Measures

  1. postoperative stay of RAAC-type treatment [5 days]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 75 Years
Sexes Eligible for Study:
Male
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Clinique Saint Augustin Bordeaux Nouvelle Aquitaine France 33200

Sponsors and Collaborators

  • Elsan

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Elsan
ClinicalTrials.gov Identifier:
NCT05172986
Other Study ID Numbers:
  • 2020-A03292-37
First Posted:
Dec 29, 2021
Last Update Posted:
Jan 18, 2022
Last Verified:
Jan 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Elsan
Robotic assisted

Study Results

No Results Posted as of Jan 18, 2022