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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05912764
Acronym
PRECODOM
Enrollment
440
Registered
2023-06-22
Start date
2024-01-26
Completion date
2027-08-15
Last updated
2025-11-24

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

Conditions

Adenoma

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

Interventions

OTHERPatient support

Patients will be supported by nurses before and after intervention and hospital leave

Sponsors

GCS Ramsay Santé pour l'Enseignement et la Recherche
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
45 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Re-hospitalizations and/or hospitalization extensions rate2 weeksthe percentage of re-hospitalizations and/or hospitalization extensions

Countries

France

Contacts

Primary ContactPhilippe ROUVELLAT, MD
r.rouvellat.union@gmail.com+ 33 5 61 37 82 93

Outcome results

None listed

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