Evaluation of Robot-assisted Intracorporeal Urinary Reconstruction (iRARC-KSW)
2017年9月11日 更新者：Christoph Schregel、Kantonsspital Winterthur KSW
Prospective Cohort-study for Evaluation of Clinical Outcome of Robot-assisted Cystectomy With Intracorporeal Reconstruction of Urinary Diversion
Continous evaluation of clinical and oncologic outcome of robot-assisted cystectomy with intracorporeal reconstruction of urinary diversion.
Patient Data is entered in an anonymized registry for analyzation.
研究概览
详细说明
The registry includes patients after robot-assisted cystectomy, mainly as therapy for muscle invasive urothelial carcinoma.
The urinary diversion will be completed intracorporeal either as ileal conduit or ileal neobladder.
Outcome parameters include perioperative complications, oncologic data and oncologic follow-up data (tumor classification, recurrence, survival) as well as data on functional follow up (continence, quality of life).
研究类型
观察性的
注册 (预期的)
200
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：Christoph Schregel, MD
- 邮箱：christophschregel@gmx.de
研究联系人备份
- 姓名：Orlando Burkhardt, MD
- 电话号码：+41792912821
学习地点
-
-
-
Winterthur、瑞士、8401
- 招聘中
- Kantonsspital Winterthur
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接触：
- Christoph Schregel, M.D.
- 电话号码：+14766737873 +4152264331
- 邮箱：christophschregel@gmx.de
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接触：
- Hubert John, M.D.
- 电话号码：+41522662982
- 邮箱：hubert.john@ksw.ch
-
-
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
概率样本
研究人群
Onkologic patients that qualify for radical cystectomy according to institutional tumor-board decision or patients with functional indications after failure of all other therapy modalities and receive a cystectomy
描述
Inclusion Criteria:
- age 18 years
- informed consent for operation and data use
- Oncologic patients that qualify for radical cystectomy according to institutional tumor-board decision or patients with functional indications after failure of all other therapy modalities and receive a cystectomy
Exclusion Criteria:
- age <18 years
- declined informed consent / data use
- pregnancy
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 |
|---|---|
|
Ileal Conduit
Patient with ileal conduit as reconstruction of urinary diversion after robot-assisted cystectomy
|
Removal of urinary bladder in oncologic or functional setting using a assistance of a operation robotic for laparoscopy
|
|
Neobladder
Patient with neobladder, (orthotopic, continent ileal pouch) as reconstruction of urinary diversion after robot-assisted cystectomy
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Removal of urinary bladder in oncologic or functional setting using a assistance of a operation robotic for laparoscopy
|
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 |
|---|---|---|
|
postoperative complications
大体时间：1 year
|
deviations from normal postoperative course ["Clavien-Dindo" Grade]
|
1 year
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Treatment of tumor recurrence
大体时间：through study completion, an average of 5 years
|
Treatment of tumor recurrence (radiotherapy, chemotherapy, operation)
|
through study completion, an average of 5 years
|
|
Quality of Life urology specific
大体时间：1 year
|
EORTC-BLM 30 (European Organisation for Research and Treatment of Cancer Questionaire for muscle invasive bladder cancer) questionaire for evaluation of quality of life for patients with muscle invasive bladder cancer
|
1 year
|
|
Quality of Life overall
大体时间：1 year
|
EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionaire) questionaire for evaluation of quality of life for oncologic patients
|
1 year
|
|
Operation Time
大体时间：expected 4-8 hours
|
duration of operation [min]
|
expected 4-8 hours
|
|
Postoperative Death by any cause
大体时间：through study completion, an average of 5 years
|
Death by any cause [n/months]
|
through study completion, an average of 5 years
|
|
Pouch capacity
大体时间：1 year
|
interventional measurement of pouch capacity with pressure recording catheter [ml]
|
1 year
|
|
Type of tumor-recurrence
大体时间：through study completion, an average of 5 years
|
Location of tumor recurrence (local, metastasis)
|
through study completion, an average of 5 years
|
|
Blood loss
大体时间：expected 4-8 hours
|
blood loss during operation [ml]
|
expected 4-8 hours
|
|
Time to recurrence
大体时间：through study completion, an average of 5 years
|
time until recurrence of tumor [months]
|
through study completion, an average of 5 years
|
|
Tumor specific death
大体时间：through study completion, an average of 5 years
|
Time to tumor specific death [months]
|
through study completion, an average of 5 years
|
|
Preoperative Tumor staging
大体时间：90 days
|
Preoperative Tumor staging according UICC TNM System (Union internationale contre le cancer Tumor Nodus Metastasis System)
|
90 days
|
|
Postoperative Tumor staging
大体时间：90 days
|
Postoperative Tumor staging according UICC TNM System (Union internationale contre le cancer Tumor Nodus Metastasis System)
|
90 days
|
|
Pouch-pressure
大体时间：1 year
|
interventional measurement of pouch-pressure [cmH2O]with pressure recording catheter
|
1 year
|
|
Postvoid residual urine
大体时间：1 year
|
Residual urin after voiding [ml]
|
1 year
|
|
Functional length of urethral sphincter
大体时间：1 year
|
interventional measurement of Functional length of urethral sphincter [mm] with pressure recording catheter
|
1 year
|
|
Functional pressure of urethral sphincter
大体时间：1 year
|
interventional measurement of functional pressure of urethral sphincter [cmH2O] with pressure recording catheter
|
1 year
|
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。
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)
2015年1月1日
初级完成 (预期的)
2023年6月1日
研究完成 (预期的)
2023年6月1日
研究注册日期
首次提交
2017年8月29日
首先提交符合 QC 标准的
2017年9月11日
首次发布 (实际的)
2017年9月12日
研究记录更新
最后更新发布 (实际的)
2017年9月12日
上次提交的符合 QC 标准的更新
2017年9月11日
最后验证
2017年9月1日
更多信息
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