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

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

NCT ID: NCT05912764

Condition: Adenoma

Conditions: Official terms:
Adenoma

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Supportive Care

Masking: None (Open Label)

Intervention:

Intervention type: Other
Intervention name: Patient support
Description: Patients will be supported by nurses before and after intervention and hospital leave
Arm group label: Early home return arm

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

Criteria for 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

Gender: Male

Minimum age: 45 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Clinique de l'Union

Address:
City: Saint-Jean
Zip: 31240
Country: France

Status: Recruiting

Contact:
Last name: Philippe ROUVELLAT, MD

Phone: +33561378293
Email: r.rouvellat.union@gmail.com

Start date: January 26, 2024

Completion date: August 15, 2026

Lead sponsor:
Agency: GCS Ramsay Santé pour l'Enseignement et la Recherche
Agency class: Other

Source: GCS Ramsay Santé pour l'Enseignement et la Recherche

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05912764