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

NCT05912764 | Recruiting

• 1 other identifier: 2023-A00283-42
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 1

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

Conditions

Adenoma

Outcome Measures

Primary Outcomes (1)

• Re-hospitalizations and/or hospitalization extensions rate

  the percentage of re-hospitalizations and/or hospitalization extensions

  2 weeks

Study Arms (2)

Early home return arm

EXPERIMENTAL

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

Other: Patient support

Standard Of Care arm

NO INTERVENTION

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

Interventions

Patient support OTHER

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

Early home return arm

Eligibility Criteria

• Age: 45 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead

Study Sites (1)

Clinique de l'Union

Saint-Jean, 31240, France

RECRUITING

MeSH Terms

Conditions

Adenoma

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Philippe ROUVELLAT, MD

  GCS RAMSAY SANTE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philippe ROUVELLAT, MD

CONTACT

+ 33 5 61 37 82 93; r.rouvellat.union@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: June 22, 2023
• Study Start: January 26, 2024
• Primary Completion (Estimated): August 15, 2027
• Study Completion (Estimated): August 15, 2027
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)