跳至主要内容
临床试验/NCT01827241
NCT01827241Unknown不适用

Outcome of Colonoscopy Screening and Surveillance

M.D. Anderson Cancer Center1 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2011年9月最近更新:
适应症

试验速览

阶段
不适用
入组人数
5,000
试验地点
1
主要终点
Polyp Detection in Colon Cancer Screening and Surveillance

研究概览

简要总结

With this study, we plan to review the performance of colonoscopy in colon cancer screening and surveillance, especially with the recent improvements in endoscopic technology (high definition endoscopes), use of split dose preparation which provides excellent colon preparation for detection of lesions and increasing awareness and detection of flat lesions of the colon. The findings will help us define the role of colonoscopy screening of colon polyps and flat lesions and identity areas for improvement. The data will be used for continuing quality improvement and presenting our outcomes at academic meetings and publishing our results in peer reviewed journals.

详细描述

Investigator's goal is to collect data from the endoscopy reports and clinic station reports to complete a descriptive analysis of the demographics, colonoscopy procedure performance, and assess the type of benign colon polyps detected during screening and surveillance from 02/01/2000 - 12/31/2020.

Specific variable to be reviewed:

  1. Patient Demographics: Age, Sex, Race, Height, Weight, BMI (patient privacy will be acknowledged).
  2. Indications for Colonoscopy (screening, surveillance, symptoms or tertiary referral [EMR])
  3. Comorbid conditions: , cancer and surgical history, medical conditions,
  4. Colonoscopy procedure; quality of colon preparation (using the Boston Bowel Preparation Scale) 0 - 3 for each section of the colon (Ascending, Transverse, Descending and Total Colon) , cecal intubation rate, cecal intubation and total procedure time, type of colonoscope (if CO2 was used in the procedure and techniques for colonoscope insertion, including position changes.
  5. Examination findings: number of polyps and nature of polyps removed (site, size, surface, vascular pattern); type of polyp removed (serrated and sessile (flat) ; optical features and histology of polyps.
  6. Resection techniques: biopsy, snare resection, endoscopic mucosal resection etc.
  7. Including Pathology report findings so that a comparison can be made of the optical features and actual pathology report.
  8. Outcomes of colonoscopy: adenoma detections (tubular and villous), cancer and quality metrics.
  9. Outcome of colonoscopy: Complications (Bleeding and performance).

研究设计

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

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

  • All Patients who have undergone colonoscopy for screening, surveillance or symptom evaluation.

排除标准

  • 未提供

结局指标

主要结局

Polyp Detection in Colon Cancer Screening and Surveillance

时间窗: 9 years

Descriptive tables presented for demographics, polyp counts, colonoscopy experiences, polyp removals and findings. Proportions presented with 95% confidence intervals. Continuous values such as age and times presented with median, minimum and maximum. Comparisons among patient subgroups made with chi-square tests for categorical data and t-tests or the non-parametric alternative, Wilcoxon tests, to compare continuous measures. Graphics such as box plots, trellis plots, bar graphs, or stacked bar graphs used to describe distributions overall and among subgroups.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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