Patient Experiences Following Urinary Diversion as Part of Surgery for Advanced and Recurrent Rectal Cancer (Pelvex 3)
2021年2月6日 更新者:Professor Des Winter、St Vincent's University Hospital, Ireland
Surgical and Patient-entered Experiences Following Urinary Reconstruction After Pelvic Exenteration for Locally Advanced and Recurrent Rectal Cancer
The outcomes of patients who undergo radical surgery for locally advanced and recurrent rectal cancer have improved vastly, but there is a lack of emphasis on the quality-of-life outcomes of these patients.
This study will assess the patient experience of having a stoma for urinary diversion as part of surgery for advanced pelvic malignancy.
This will be assessed at regular intervals both before and after surgery with the goal of increasing awareness of patient beliefs and concerns with regards to their stomas and to devise interventions that will improve their quality-of-life.
研究概览
详细说明
Considerable progress has been made in the management of advanced and recurrent pelvic cancer over the last few decades.
However, much emphasis has been placed on surgical and hospital-related outcomes.
In recent years, there has been an increased focus on patient quality-of-life following major abdominopelvic surgery.
However, there is a lack of updated evidence on how patients manage and perceive their stomas.
Managing a stoma is a difficult task for patients and can adversely effect their quality-of-life.
This study will investigate specifically the impact of managing a urostomy or ileal conduit.
Patients will be contacted via an anonymized, opt-in SMS or email to answer a questionnaire, having previously been provided with a patient information leaflet.
This will take approximately 5 minutes to complete and will be carried out just prior to and at 1, 3, 6, 9 and 12 months post-operatively.
All of this data will be collated and published as part of a wider investigation in to patient quality-of-life following major abdominal and pelvic surgery.
This study will be carried out in 35 countries.
研究类型
观察性的
注册 (预期的)
1200
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:Matthew Fahy, MB
- 电话号码:00353874510237
- 邮箱:MFahy94@gmail.com
研究联系人备份
- 姓名:Michael Kelly, MD
- 邮箱:kellym11@tcd.ie
学习地点
-
-
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Dublin、爱尔兰、D4
- 招聘中
- St. Vincent's Hospital
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接触:
- Des Winter, MD
- 邮箱:pelvexcollaborative@gmail.com
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-
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
Cohort of patients who are undergoing surgery for locally advanced or recurrent rectal cancer and are undergoing a urinary diversion or reconstruction.
描述
Inclusion Criteria:
- Histologically-proven advanced rectal cancer
- Has undergone urinary diversion/reconstruction
- Aged 18 years or older
- Able and willing to give written, informed consent
- Able to access email/internet
Exclusion Criteria:
- Strong evidence of metastatic or peritoneal disease
- Palliative exenteration
- Non-rectal origin of primary tumour
- Colonic obstruction
- Inability to answer online questionnaire
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
- 观测模型:队列
- 时间观点:预期
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 |
---|---|---|
To determine the 30-day complication rate of urinary diversion/reconstruction following pelvic exenteration
大体时间:2 years
|
Morbidity of urinary diversion/reconstruction
|
2 years
|
To assess the impact of urinary diversion/reconstruction subtypes on quality-of-life
大体时间:Before surgery and at 1, 3, 6, 9 and 12 months respectively
|
Patient-reported outcomes assessing their quality-of-life
|
Before surgery and at 1, 3, 6, 9 and 12 months respectively
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
To assess the longer-term complications associated with urinary diversion/reconstruction
大体时间:1 month - 12 months
|
Morbidity of urinary diversion or reconstruction over longer than 1 month but less than 1 year
|
1 month - 12 months
|
To measure the rate of reintervention for complications associated with urinary diversion/reconstruction
大体时间:12 months
|
Rate of reintervention
|
12 months
|
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)
2020年12月1日
初级完成 (预期的)
2021年12月1日
研究完成 (预期的)
2022年3月1日
研究注册日期
首次提交
2021年1月14日
首先提交符合 QC 标准的
2021年1月14日
首次发布 (实际的)
2021年1月20日
研究记录更新
最后更新发布 (实际的)
2021年2月10日
上次提交的符合 QC 标准的更新
2021年2月6日
最后验证
2021年2月1日
更多信息
与本研究相关的术语
关键字
其他研究编号
- STVINCENTSIRELAND
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
不
IPD 计划说明
No individual patient date other than their responses to the questionnaire will be collected or shared.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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.
生活质量的临床试验
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Swansea University完全的
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Yale-NUS College完全的
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Scripps Translational Science Institute完全的