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

Официальное название

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

Обзор

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

Подробное описание

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

Вмешательства

• Другое Patient support
  Patients will be supported by nurses before and after intervention and hospital leave

Первичные конечные точки

• Re-hospitalizations and/or hospitalization extensions rate [Срок оценки: 2 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Франция · 1 центр

• Clinique de l'Union — Saint-Jean

Идентификаторы

NCT: NCT05912764 · 2023-A00283-42

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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