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Evaluation of Early Home Return in Patients With Enucleation of Prostate Adenoma (PRECODOM)

G

GCS Ramsay Santé pour l'Enseignement et la Recherche

Status

Enrolling

Conditions

Adenoma

Treatments

Other: Patient support

Study type

Interventional

Funder types

Other

Identifiers

NCT05912764
2023-A00283-42

Details and patient eligibility

About

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

Full 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

Enrollment

440 estimated patients

Sex

Male

Ages

45+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

440 participants in 2 patient groups

Early home return arm
Experimental group
Description:
Nurses will coordinate the patients' care prior to their intervention and when they leave the Clinics.
Treatment:
Other: Patient support
Standard Of Care arm
No Intervention group
Description:
Patients will not receive any support before and after intervention and hospital leave

Trial contacts and locations

1

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Central trial contact

Philippe ROUVELLAT, MD

Data sourced from clinicaltrials.gov

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