Evaluation of Early Home Return in Patients With Enucleation of Prostate Adenoma (PRECODOM)

Evaluation of Early Home Return Care Pathway in Patients Who Have Undergone Endoscopic Enucleation of Prostate Adenoma by Laser

Prostate adenoma management includes, if necessary, surgical treatments: resection or vaporization by endoscopy or by open surgery in case of a very large prostate. Laser technology is a curative treatment for prostate adenoma. The minimum duration of hospitalization, in the context of enucleation prostatic endoscopy by laser, is estimated at 48 hours.

The Union Clinique has developed an improved rehabilitation care pathway reducing hospitalization duration to 24 hours (one night hospitalization). This care pathway involves patient as an actor in its care but also health professionals, in particular nurses.

This study is based on the hypothesis that the model developed by the Union Clinique can be translated to other healthcare establishments and that home return supervized by nurses allows reducing hospital stay length without increasing the risk of serious complications for patients

Study Overview

• Status: Recruiting
• Conditions: Adenoma
• Intervention / Treatment: Other: Patient support

Detailed Description

Prostate adenoma management includes first drug treatments and, if necessary, surgical treatments: resection or vaporization by endoscopy or by open surgery in case of a very large prostate. Laser technology is a curative treatment for prostate adenoma. Its objective is to perform endoscopic excision (ablation) of the adenoma, in order to improve patients' quality of life and their urination. The laser energy is transmitted by a guided fiber under endoscopic control through the urethral canal in contact with the adenoma. Several wavelengths of the laser beam, depending on the nature of the generator crystals, are used for their specificity in cutting and tissue cauterization: Greenlight laser, Holmium laser, Thulium laser.

The minimum duration of hospitalization, in the context of an enucleation prostatic endoscopy by laser, is estimated at 48 hours. The Union Clinique has developed an improved rehabilitation care pathway reducing hospitalization duration to 24 hours (one night hospitalization). This care pathway involves patient as an actor in its care but also health professionals, in particular nurses, who will coordinate patients care prior to their intervention and when they leave the Clinics.

This study is based on the hypothesis that the model developed by the Union Clinique can be translated to other healthcare establishments and that home return supervized by health professionals, notably nurses, allows reducing hospital stay length without increasing the risk of serious complications for patients

• Study Type: Interventional
• Enrollment (Estimated): 440
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Philippe ROUVELLAT, MD; Phone Number: + 33 5 61 37 82 93; Email: r.rouvellat.union@gmail.com

Study Locations

• France
  • Saint-Jean, France, 31240
    • Recruiting
    • Clinique de l'Union
    • Contact: Philippe ROUVELLAT, MD; Phone Number: +33561378293; Email: r.rouvellat.union@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient planned for endoscopic enucleation of prostate adenoma with laser
• Patient with symptomatic benign prostatic hyperplasia and refractory to medical reatment and/or
• Patient with benign prostatic hyperplasia complicated by chronic retention of urine and/or
• Patient with benign prostatic hyperplasia complicated by prostatitis and/or
• Patient with symptomatic benign prostatic hyperplasia

Exclusion Criteria:

• Patient living beyond the scope of care by the nurses coordination
• Bedridden patient or WHO clinical condition >2
• Patient requiring curative anticoagulation which cannot be interrupted or relayed at home by heparin
• Patient with double anti-platelet aggregation who cannot be interrupted

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early home return arm; Nurses will coordinate the patients' care prior to their intervention and when they leave the Clinics.	Other: Patient support; Patients will be supported by nurses before and after intervention and hospital leave
No Intervention: Standard Of Care arm; Patients will not receive any support before and after intervention and hospital leave

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Re-hospitalizations and/or hospitalization extensions rate	the percentage of re-hospitalizations and/or hospitalization extensions	2 weeks

Collaborators and Investigators

• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Investigators: Principal Investigator: Philippe ROUVELLAT, MD, GCS RAMSAY SANTE

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2024
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): August 15, 2026

Study Registration Dates

• First Submitted: June 12, 2023
• First Submitted That Met QC Criteria: June 12, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Adenoma
• Other Study ID Numbers: 2023-A00283-42

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No