Clinical trial NCT05912764: Evaluation of Early Home Return in Patients With Enucleation of Prostate Adenoma
Official title: Evaluation of Early Home Return Care Pathway in Patients Who Have Undergone Endoscopic Enucleation of Prostate Adenoma by Laser
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Adenoma
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
First posted: 2023-06-22
Enrollment: 440
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

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

Primary outcomes:
measure: Re-hospitalizations and/or hospitalization extensions rate
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-Jean
country: France
facility: Clinique de l'Union
Study officials:
affiliation: GCS RAMSAY SANTE
name: Philippe ROUVELLAT, MD
role: PRINCIPAL_INVESTIGATOR
References: