Assessing the Agreement Between Endoscopic and Histopathological Diagnosis of Colorectal Sessile Serrated Lesions.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 772
- 试验地点
- 1
- 主要终点
- To assess the degree of agreement between the endoscopic and the anatomopathological diagnosis of sessile serrated colorectal lesions
研究概览
简要总结
The goal of this observational study was to assess the degree of agreement between the endoscopic and anatomopathological diagnosis of sessile serrated colorectal lesions in adult patients undergoing colonoscopy in Hospital Sírio-Libanes.
The main questions it aimed to answer were:
- The degree of agreement between endoscopic and anatomopathological diagnosis of sessile serrated colorectal lesions by calculating the Kappa Value of agreement.
- To establish the detection rate of sessile serrated lesions and adenomas in the Endoscopy Department at Hospital Sírio-Libanês.
- To evaluate the degree of agreement between endoscopic and anatomopathological diagnosis of sessile serrated colorectal lesions based on the resection method.
- To assess the accuracy, positive predictive value, and negative predictive value of endoscopic diagnosis of serrated lesions compared to anatomopathological diagnosis.
The data were prospectively collected through a form specifically designed for this project, that was completed immediately after the examination by the performing colonoscopist. All patients enrolled in this study agreed to participate in it and signed an informed consent form prior to the colonoscopy.
详细描述
The study population was:
Patients aged over 18 undergoing colonoscopy at Hospital Sírio-Libanês in the Bela-Vista unit, São Paulo, Brazil, between June and August 2020.
The sample:
For the present study, an odds ratio of 1.5 in the adenoma detection rate of colorectal lesions was considered concerning the vascular pattern classification of the lesion (NICE), with an expected discordance rate of 30% regarding the histopathological pattern. To achieve this, an estimated sample size of 758 patients was calculated, considering an 80% statistical power and a risk α≤5% for a Type I error, using the McNemar's test for proportions.
Inclusion criteria:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- 是
入选标准
- •Patients undergoing elective colonoscopy at Hospital Sírio-Libanês between February 2020 and August
- •Age over 18 years.
排除标准
- •Patients with inflammatory bowel disease (IBD)
- •Patients diagnosed with hereditary polyposis or non-polyposis syndromes.
- •Patients with a history of colorectal surgery.
- •Patients previously diagnosed with colorectal cancer (CRC).
结局指标
主要结局
To assess the degree of agreement between the endoscopic and the anatomopathological diagnosis of sessile serrated colorectal lesions
时间窗: 2 years
To evaluate concordance between colonoscopy diagnosis and anatomopathological diagnosis, both overall and according to the resection method employed, Cohen's Kappa coefficients and their respective 95% confidence intervals were calculated. These coefficients were then categorized based on Landis \& Koch's criteria (1977).
次要结局
- Evaluate the degree of agreement between endoscopic and anatomopathological diagnosis of sessile serrated colorectal lesions based on the resection method.(2 years)
- To establish the detection rate of sessile serrated lesions and adenomas in the Endoscopy Department at Hospital Sírio-Libanês.(2 years)
- Assess the accuracy, positive predictive value, and negative predictive value of endoscopic diagnosis of serrated lesions compared to anatomopathological diagnosis.(2 years)