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

Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05912764
Collaborator
(none)
440
2
24.5

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Other: Patient support
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
440 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Evaluation of Early Home Return Care Pathway in Patients Who Have Undergone Endoscopic Enucleation of Prostate Adenoma by Laser
Anticipated Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Aug 15, 2025
Anticipated Study Completion Date :
Aug 15, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Re-hospitalizations and/or hospitalization extensions rate [2 weeks]

    the percentage of re-hospitalizations and/or hospitalization extensions

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • GCS Ramsay Santé pour l'Enseignement et la Recherche

Investigators

  • Principal Investigator: Philippe ROUVELLAT, MD, GCS RAMSAY SANTE

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
GCS Ramsay Santé pour l'Enseignement et la Recherche
ClinicalTrials.gov Identifier:
NCT05912764
Other Study ID Numbers:
  • 2023-A00283-42
First Posted:
Jun 22, 2023
Last Update Posted:
Jun 26, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 26, 2023