Robotic Radical Cystectomy Outcomes
2021年5月19日 更新者：Simone Morselli、University of Florence
Impact of Robotic Surgery on Post-operative Outcomes of Patients Who Underwent Radical Cystectomy
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
研究概览
研究类型
观察性的
注册 (预期的)
500
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Simone Morselli, MD
- 电话号码：3473050852
- 邮箱：simone.morselli.89@gmail.com
研究联系人备份
- 姓名：Silvia Benemei, PhD
- 邮箱：silvia.benemei@unifi.it
学习地点
-
-
Tuscany
-
Florence、Tuscany、意大利、50134
- 招聘中
- Careggi University Hospital
-
副研究员：
- Mauro Gacci, MD
-
副研究员：
- Riccardo Campi, MD
-
接触：
- Arcangelo Sebastianelli, MD
- 邮箱：arcangelo.sebastianelli@gmail.com
-
首席研究员：
- Simone Morselli, MD
-
副研究员：
- Maria Rosaria Raspollini, MD
-
首席研究员：
- Arcangelo Sebastianelli, MD
-
副研究员：
- Donata Villari, MD
-
副研究员：
- Graziano Vignolini, MD
-
副研究员：
- Saverio Giancane, MD
-
副研究员：
- Pietro Spatafora, MD
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
The study population is made up of patients who underwent radical cystectomy at AOU Careggi, SOD Robotic Urological Surgery, Minimally Invasive and Renal Transplantation.
描述
Inclusion Criteria:
- Age major or equal 18 years
- Patients who will undergo radical cystectomy
- Consent to participate
Exclusion Criteria:
- Absence of willingness to participate
- Further refusal to participate to the study
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Radical Cystectomy
Patients who underwent radical cystectomy for bladder cancer in our centre
|
All the patients enrolled have undergone or will undergo radical cystectomy, with or without lymphadenectomy or urethrectomy All possibles urinary diversion are included, like ileal conduit, neobladder etc...
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of participants who will die from bladder cancer
大体时间：From enrollment to late follow-up, up to 7 years
|
Bladder Cancer Specific Mortality after surgery
|
From enrollment to late follow-up, up to 7 years
|
|
Number of participants who will experience bladder cancer recurrence
大体时间：From enrollment to late follow-up, up to 7 years
|
Bladder Cancer Recurrence
|
From enrollment to late follow-up, up to 7 years
|
|
Number of participants who will die from all causes
大体时间：From enrollment to late follow-up, up to 7 years
|
All cause mortality after surgery
|
From enrollment to late follow-up, up to 7 years
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of participants who will die from bladder cancer after Robotic Surgery
大体时间：From enrollment to late follow-up, up to 7 years
|
Robotic surgery specific impact on survival
|
From enrollment to late follow-up, up to 7 years
|
|
Number of participants who will experience bladder cancer recurrence after Robotic Surgery
大体时间：From enrollment to late follow-up, up to 7 years
|
Robotic surgery specific impact on recurrence
|
From enrollment to late follow-up, up to 7 years
|
|
Number of participants who will experience surgical complications after Robotic Surgery
大体时间：From enrollment to late follow-up, up to 7 years
|
Robotic surgery specific impact on surgical complications
|
From enrollment to late follow-up, up to 7 years
|
|
Variation in Quality of Life questionnaire after Robotic Surgery
大体时间：From enrollment to late follow-up, up to 7 years
|
Robotic surgery specific impact on quality of life according to European Organisation for Research and Treatment of Cancer (EORTC) core quality of life questionnaire (QLQ-C30)
|
From enrollment to late follow-up, up to 7 years
|
|
Variation in Quality of Life questionnaire according to Urinary diversions
大体时间：From enrollment to late follow-up, up to 7 years
|
Urinary diversion specific impact on quality of life according to European Organisation for Research and Treatment of Cancer (EORTC) core quality of life questionnaire (QLQ-C30)
|
From enrollment to late follow-up, up to 7 years
|
|
Number of participants who will experience surgical complications according to Urinary diversions
大体时间：From enrollment to late follow-up, up to 7 years
|
Urinary diversion specific impact on surgical complications
|
From enrollment to late follow-up, up to 7 years
|
|
Number of participants who will experience bladder cancer recurrence according to Urinary diversions
大体时间：From enrollment to late follow-up, up to 7 years
|
Urinary diversion specific impact on bladder cancer recurrence
|
From enrollment to late follow-up, up to 7 years
|
|
Number of participants who will die from bladder cancer according to Urinary diversions
大体时间：From enrollment to late follow-up, up to 7 years
|
Urinary diversion specific impact on bladder cancer rmortality
|
From enrollment to late follow-up, up to 7 years
|
|
Number of participants who will die from all causes according to Urinary diversions
大体时间：From enrollment to late follow-up, up to 7 years
|
Urinary diversion specific impact on all cause mortality after surgery
|
From enrollment to late follow-up, up to 7 years
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Arcangelo Sebastianelli, MD、Careggi Hospital, University of Florence
- 首席研究员：Simone Morselli, MD、University of Florence
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2021年4月29日
初级完成 (预期的)
2031年2月1日
研究完成 (预期的)
2038年2月1日
研究注册日期
首次提交
2021年5月3日
首先提交符合 QC 标准的
2021年5月19日
首次发布 (实际的)
2021年5月25日
研究记录更新
最后更新发布 (实际的)
2021年5月25日
上次提交的符合 QC 标准的更新
2021年5月19日
最后验证
2021年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.