Comparing Right Colon Adenoma and Hyperplastic Polyp Miss Rates in Colonoscopy Using Water Exchange and CO2 Insufflation: A Multicenter Randomized Tandem Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 386
- 试验地点
- 1
- 主要终点
- Right Colon Hyperplastic Polyp Miss Rate
研究概览
简要总结
A prospective multicenter randomized controlled trial (RCT) comparing water exchange (WE) colonoscopy and carbon dioxide (CO2) insufflation in terms of right colon combined adenoma miss rate (AMR) and hyperplastic polyp miss rate (HPMR) by tandem inspection.
详细描述
This will be a prospective RCT comparing CO2 insufflation and WE in terms of right colon combined AMR and HPMR by tandem inspection. It will be a multicenter study conducted in three community hospitals (Evergreen General Hospital, Taoyuan; Dalin Tzu-Chi Hospital, Chiayi; Taipei Medical University Hospital, Taipei) in Taiwan. Consecutive patients aged 45 years or older undergoing colonoscopy for screening, surveillance, and positive FIT will be considered for enrollment from December 2019 to May 2021. A written informed consent will be obtained from all participating patients. Participants will be randomized in a 1:1 ratio to undergo either the CO2 insufflation colonoscopy (CO2 group) or WE colonoscopy (WE group). WE colonoscopies will be performed by five board-certified colonoscopists (Chi-Liang Cheng, Yen-Lin Kuo [Evergreen General Hospital]; Yu-Hsi Hsieh, Chih-Wei Tseng [Dalin Tzu-Chi Hospital]; Jui-Hsiang Tang [Taipei Medical University Hospital]. Standard colonoscopes (CF-Q260AL/I, CF-HQ290L/I; Olympus Medical Systems Corp., Tokyo, Japan) will be used. Felix W. Leung will be involved in the study design, data analyses, and report preparation, but not in patient enrollment. Antispasmodic medication will not be administered during colonoscopy examination. CO2 insufflation will be used for CO2 group and the withdrawal phase of the WE group. In the WE group, the air pump will be turned off before starting the procedure. During the insertion phase, air and residual water or feces in the rectum will be aspirated, and then the colon will be irrigated with warm water. When the cecum is reached and after most of the water is suctioned to collapse the cecal lumen, CO2 will be opened. In the CO2 group, colonoscopy is performed in the usual fashion, with minimal insufflation required to aid insertion. Cleaning in the CO2 group will be performed entirely during withdrawal. Upon arriving at the cecum, CO2 insufflation will be used in both groups and the scope will be withdrawn from the cecum to the hepatic flexure, with inspection of the mucosa at the same time. All polyps identified will be resected and sent for pathology evaluation. The most distal part of the hepatic flexure will be marked by a forceps biopsy and then the scope will be reinserted into the cecum by the first endoscopist using CO2 insufflation. A tandem inspection of the right colon will then be performed by a blinded endoscopist in both study groups. All polyps found herein will be counted as the missed polyps. After the second withdrawal to the mark of distal hepatic flexure, the remainder of the colon will be examined in a standard manner by the first endoscopist. Polyp search and resection will be performed during the withdrawal phase in both groups. Insertion polypectomy will not be performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The second endoscopist will perform tandem right colon examination and is blinded to the insertion method used by the first endoscopist.
入排标准
- 年龄范围
- 45 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consecutive patients aged 45 years or older undergoing colonoscopy for screening, surveillance, and positive fecal immunochemical test will be considered for enrollment.
排除标准
- •Familial adenomatous polyposis and hereditary non-polyposis colorectal cancer (CRC) syndrome, personal history of CRC or inflammatory bowel disease, previous colonic resection, obstructive lesions of the colon, gastrointestinal bleeding, allergy to fentanyl, midazolam or propofol, American Society of Anesthesiology classification of physical status grade 3 or higher, mental retardation, pregnancy, and refusal to provide a written informed consent.
结局指标
主要结局
Right Colon Hyperplastic Polyp Miss Rate
时间窗: One day
Lesions detected on the tandem right colon examination will be used for the calculation of hyperplastic polyp miss rate. Right colon hyperplastic polyp miss rate will be calculated as the the number of hyperplastic polyps missed during the first right colon examination divided by the total number of hyperplalstic polyps detected during both the first and tandem right colon examinations.
Right Colon Adenoma Miss Rate
时间窗: One day
Lesions detected on the tandem right colon examination will be used for the calculation of adenoma miss rate. Right colon adenooma miss rate will be calculated as the the number of adenomas missed during the first right colon examination divided by the total number of adenomas detected during both the first and tandem right colon examinations.
次要结局
未报告次要终点
