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

Primary Purpose

Adenoma

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Patient support
Sponsored by
GCS Ramsay Santé pour l'Enseignement et la Recherche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Adenoma

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Early home return arm

    Standard Of Care arm

    Arm Description

    Nurses will coordinate the patients' care prior to their intervention and when they leave the Clinics.

    Patients will not receive any support before and after intervention and hospital leave

    Outcomes

    Primary Outcome Measures

    Re-hospitalizations and/or hospitalization extensions rate
    the percentage of re-hospitalizations and/or hospitalization extensions

    Secondary Outcome Measures

    Full Information

    First Posted
    June 12, 2023
    Last Updated
    June 22, 2023
    Sponsor
    GCS Ramsay Santé pour l'Enseignement et la Recherche
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05912764
    Brief Title
    Evaluation of Early Home Return in Patients With Enucleation of Prostate Adenoma
    Acronym
    PRECODOM
    Official Title
    Evaluation of Early Home Return Care Pathway in Patients Who Have Undergone Endoscopic Enucleation of Prostate Adenoma by Laser
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 1, 2023 (Anticipated)
    Primary Completion Date
    August 15, 2025 (Anticipated)
    Study Completion Date
    August 15, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    GCS Ramsay Santé pour l'Enseignement et la Recherche

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Adenoma

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    440 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Early home return arm
    Arm Type
    Experimental
    Arm Description
    Nurses will coordinate the patients' care prior to their intervention and when they leave the Clinics.
    Arm Title
    Standard Of Care arm
    Arm Type
    No Intervention
    Arm Description
    Patients will not receive any support before and after intervention and hospital leave
    Intervention Type
    Other
    Intervention Name(s)
    Patient support
    Intervention Description
    Patients will be supported by nurses before and after intervention and hospital leave
    Primary Outcome Measure Information:
    Title
    Re-hospitalizations and/or hospitalization extensions rate
    Description
    the percentage of re-hospitalizations and/or hospitalization extensions
    Time Frame
    2 weeks

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Philippe ROUVELLAT, MD
    Phone
    + 33 5 61 37 82 93
    Email
    r.rouvellat.union@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Philippe ROUVELLAT, MD
    Organizational Affiliation
    GCS RAMSAY SANTE
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Evaluation of Early Home Return in Patients With Enucleation of Prostate Adenoma

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