Prospective Study of Colonoscopic Resection of Large Polyps and Flat Lesions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- Composite Data Review of Colonoscopic Resection of Colon Polyps and Flat Lesions
研究概览
简要总结
With this study, the investigators plan to review the performance of colonoscopic resection of large (> 1 cm) and flat lesions in the colon. The findings will help us define the role of colonoscopic resection 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
Our goal is to collect data from our endoscopy reports (Endoscopy Clinic database) and electronic medical record system (Clinic Station) to complete a descriptive analysis of the 1) demographics, 2) colonoscopy resection procedure, and 3) outcome of resection - immediate and delayed complications, tumor recurrence, and cancer during follow-up 01/01/2014 - 12/31/2025.
Specific variable to be reviewed:
- Patient Demographics: Age, Sex, Race, Height, Weight, BMI (patient privacy will be acknowledged).
- Indications for Colonoscopy (screening, surveillance, symptoms or tertiary referral [EMR])
- Comorbid conditions: cancer and surgical history, medical conditions.
- 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.
- 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.
- Resection techniques: Biopsy, snare resection, endoscopic mucosal resection, endoscopic submucosal dissection etc.
- Including Pathology report findings so that a comparison can be made of the optical features and actual pathology report.
- Outcomes of colonoscopy: Complete or incomplete resection, local recurrence, need for surgery, etc
- Outcome of colonoscopy: Complications (Bleeding and perforation).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All Patients who have been referred for endoscopic resection of large polyps (>1 cm) and flat lesions.
排除标准
- 未提供
结局指标
主要结局
Composite Data Review of Colonoscopic Resection of Colon Polyps and Flat Lesions
时间窗: 1 day
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