NCT05912764 Evaluation of Early Home Return in Patients With Enucleation of Prostate Adenoma
| NCT ID | NCT05912764 |
| Status | Recruiting |
| Phase | — |
| Sponsor | GCS Ramsay Santé pour l'Enseignement et la Recherche |
| Condition | Adenoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 440 participants |
| Start Date | 2024-01-26 |
| Primary Completion | 2027-08-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 440 participants in total. It began in 2024-01-26 with a primary completion date of 2027-08-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
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
Contact & Investigator
Philippe ROUVELLAT, MD
PRINCIPAL INVESTIGATOR
GCS RAMSAY SANTE
Frequently Asked Questions
Who can join the NCT05912764 clinical trial?
This trial is open to male participants only, aged 45 Years or older, studying Adenoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05912764 currently recruiting?
Yes, NCT05912764 is actively recruiting participants. Contact the research team at r.rouvellat.union@gmail.com for enrollment information.
Where is the NCT05912764 trial being conducted?
This trial is being conducted at Saint-Jean, France.
Who is sponsoring the NCT05912764 clinical trial?
NCT05912764 is sponsored by GCS Ramsay Santé pour l'Enseignement et la Recherche. The principal investigator is Philippe ROUVELLAT, MD at GCS RAMSAY SANTE. The trial plans to enroll 440 participants.