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临床试验/NCT05912764
NCT05912764招募中不适用

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

GCS Ramsay Santé pour l'Enseignement et la Recherche2 个研究点 分布在 1 个国家目标入组 440 人开始时间: 2024年1月26日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
440
试验地点
2
主要终点
Re-hospitalizations and/or hospitalization extensions rate

研究概览

简要总结

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

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
45 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Re-hospitalizations and/or hospitalization extensions rate

时间窗: 2 weeks

the percentage of re-hospitalizations and/or hospitalization extensions

次要结局

未报告次要终点

研究者

发起方
GCS Ramsay Santé pour l'Enseignement et la Recherche
申办方类型
Other
责任方
Sponsor

研究点 (2)

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