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临床试验/NCT04900558
NCT04900558招募中不适用

Impact of Robotic Surgery on Post-operative Outcomes of Patients Who Underwent Radical Cystectomy

University of Florence1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2021年4月29日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
500
试验地点
1
主要终点
Number of participants who will experience bladder cancer recurrence

研究概览

简要总结

Currently, in the treatment of bladder cancer the use of robotics has entered in clinical practice, therefor robotic radical cystectomy with or without reconstruction is offered to patients during counseling procedures, if deemed appropriate and possible. The aim of the study is therefore the long-term evaluation of the peri-post-operative, oncological and functional results of patients undergoing radical cystectomy, both with an open and robotic approach. This study will thus help to clarify the actual impact of robotic surgery

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

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

入选标准

  • Age major or equal 18 years
  • Patients who will undergo radical cystectomy
  • Consent to participate

排除标准

  • Absence of willingness to participate
  • Further refusal to participate to the study

结局指标

主要结局

Number of participants who will experience bladder cancer recurrence

时间窗: From enrollment to late follow-up, up to 7 years

Bladder Cancer Recurrence

Number of participants who will die from bladder cancer

时间窗: From enrollment to late follow-up, up to 7 years

Bladder Cancer Specific Mortality after surgery

Number of participants who will die from all causes

时间窗: From enrollment to late follow-up, up to 7 years

All cause mortality after surgery

次要结局

  • Number of participants who will experience surgical complications according to Urinary diversions(From enrollment to late follow-up, up to 7 years)
  • Number of participants who will experience bladder cancer recurrence according to Urinary diversions(From enrollment to late follow-up, up to 7 years)
  • Number of participants who will die from all causes according to Urinary diversions(From enrollment to late follow-up, up to 7 years)
  • Variation in Quality of Life questionnaire after Robotic Surgery(From enrollment to late follow-up, up to 7 years)
  • Number of participants who will experience bladder cancer recurrence after Robotic Surgery(From enrollment to late follow-up, up to 7 years)
  • Variation in Quality of Life questionnaire according to Urinary diversions(From enrollment to late follow-up, up to 7 years)
  • Number of participants who will die from bladder cancer according to Urinary diversions(From enrollment to late follow-up, up to 7 years)
  • Number of participants who will die from bladder cancer after Robotic Surgery(From enrollment to late follow-up, up to 7 years)
  • Number of participants who will experience surgical complications after Robotic Surgery(From enrollment to late follow-up, up to 7 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Simone Morselli

PhD Student

University of Florence

研究点 (1)

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