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NCT Number: NCT05912764

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

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

Recruiting

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Key information

Age range

45 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Clinique de l'Union

Saint-Jean, 31240, France

Location status: Recruiting

Location contact

Philippe ROUVELLAT, MD

CONTACT

[email protected]

+33561378293

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patient support

Other

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

Primary outcomes

  1. Re-hospitalizations and/or hospitalization extensions rate

    Time frame: 2 weeks

    the percentage of re-hospitalizations and/or hospitalization extensions

Study contacts

Contact information is provided by the study sponsor or research team.

Philippe ROUVELLAT, MD

CONTACT

[email protected]

+ 33 5 61 37 82 93

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Registry information

Official study title

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

Acronym: PRECODOM

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jun 22, 2023
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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