CT Carcinogenic Risk in Patients With Appendicitis
2020年2月12日 更新者：Ji Hoon Park、Seoul National University Bundang Hospital
Carcinogenic Risk of CT in Patients With Appendicitis
The purpose of this study is to compare the incidence rate of leukemia between CT-exposed and CT-unexposed group in patients who underwent appendectomy in South Korea.
研究概览
详细说明
South Korea has a single-payer healthcare system, administered by National Health Insurance Service (NHIS).
As healthcare providers in South Korea need to claim reimbursement to NHIS for the vast majority of diagnostic and therapeutic procedures, the NHIS database enabled us to construct a large cohort who did or did not undergo CT for appendicitis.
The purpose of this study is to compare the incidence rate of cancer between CT-exposed and CT-unexposed group in patients who underwent appendectomy in South Korea.
研究类型
观察性的
注册 (预期的)
1000000
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。
学习地点
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Gyeonggi-do
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Seongnam-Si、Gyeonggi-do、大韩民国、463-707
- 招聘中
- Seoul National University Bunadang Hospital
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接触：
- Min Jeong Jeong
- 电话号码：82-31-787-7607
- 邮箱：jeongminjeong1004@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
- 孩子
- 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
Patients who underwent appendectomy under the diagnosis of appendicitis
描述
Inclusion Criteria:
- Patients will be entered in the cohort on the date of appendectomy under the diagnosis of appendicitis
Exclusion Criteria:
- (a) patients who had a cancer diagnosis before the date of appendectomy,
- (b) those who had prior experience of CT examination more than 7 days before appendectomy,
- (c) those who had syndromes or diseases predisposing cancers,
- (d) those whose diagnosis was changed to appendiceal cancer and
- (e) those whose follow-up duration was shorter than a lag period.
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 |
|---|---|
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CT-exposed group
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Patients are divided into CT-exposed or unexposed group according to the presence of claims codes of abdominopelvic CT conducted within seven days before and after appendectomy.
The seven-day threshold is arbitrarily determined considering the delay in the diagnosis of appendicitis and the postoperative examination for surgical complication.
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CT-unexposed group
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Patients are divided into CT-exposed or unexposed group according to the presence of claims codes of abdominopelvic CT conducted within seven days before and after appendectomy.
The seven-day threshold is arbitrarily determined considering the delay in the diagnosis of appendicitis and the postoperative examination for surgical complication.
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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 |
|---|---|---|
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Age and sex-standardized incidence rate ratio (IRR) for malignancies of hematologic system
大体时间：Cancer occurrence after a lag period (2 years)
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Hematologic malignancies are categorized into lymphomas, multiple myeloma, leukemias, myelodysplasia and others using ICD-10 codes.
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Cancer occurrence after a lag period (2 years)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Age and sex-standardized incidence rate ratio (IRR) for malignancies of abdominal organs
大体时间：Cancer occurrence after a lag period (2 years)
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age and sex-standardized IRRs for malignancies of abdominal organs for CT-exposed versus unexposed patients.
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Cancer occurrence after a lag period (2 years)
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Age and sex-standardized incidence rate ratio (IRR) for all cancers
大体时间：Cancer occurrence after a lag period (2 years)
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age and sex-standardized IRRs for all cancers for CT-exposed versus unexposed patients.
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Cancer occurrence after a lag period (2 years)
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Sensitivity analysis
大体时间：Cancer occurrence after different lag periods (6 months, 1 year, 3 years and 5 years)
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Various lag periods will be applied for the outcomes.
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Cancer occurrence after different lag periods (6 months, 1 year, 3 years and 5 years)
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Subgroup analysis by subsequent CT scans conducted more than 7 days after appendectomy
大体时间：CT undergone more than 7 days after appendectomy will be counted.
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IRR in patients who underwent CT after appendectomy IRR in patients who did not undergo CT after appendectomy
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CT undergone more than 7 days after appendectomy will be counted.
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Subgroup analysis
大体时间：Cancer occurrence after a lag period (2 years)
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by age and sex
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Cancer occurrence after a lag period (2 years)
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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)
2018年1月15日
初级完成 (预期的)
2020年12月15日
研究完成 (预期的)
2021年5月15日
研究注册日期
首次提交
2018年12月13日
首先提交符合 QC 标准的
2018年12月13日
首次发布 (实际的)
2018年12月14日
研究记录更新
最后更新发布 (实际的)
2020年2月17日
上次提交的符合 QC 标准的更新
2020年2月12日
最后验证
2020年2月1日
更多信息
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