Adenoma Detection Rate in Colonoscopy Performed With EndoRings - a Single-centre Prospective Randomised Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 97
- 试验地点
- 2
- 主要终点
- Adenoma detection rate
研究概览
简要总结
The study is designed to examine whether colonoscopy using an EndoRings cap has a higher adenoma detection rate than conventional colonoscopy. Secondary end-points is to compare completion rate, completion time, complication rate and detection of malignancies. Half of the patients will be randomised to colonoscopy using cap and the other half to no cap.
详细描述
Colonoscopy is recognised as the standard method for finding and removing colorectal adenomas, which are precursors of most colorectal cancers. It has been shown that there is a direct correlation between adenoma detection rate and the risk of developing colorectal cancer subsequently. However, patients undergoing colonoscopy are still at risk of developing colorectal cancer, mainly because precursor lesions are missed during the procedure. This may be due to insufficient bowel preparation, difficulties in visualising flat lesions or the location of lesions behind haustral folds.
Improving the ADR can be achieved by different means; better training of endoscopists, improved bowel preparation, optimal sedation and medico technical developments. The technical improvements have mainly been in the optimising of image and improved scope thickness and flexibility, including devices that improve visualisation by increasing the exposed colonic surface . One of these new inventions is the EndoRings II Distal Attachment.
According to the Danish Colorectal Cancer Screening Database, the ADR of standard screening colonoscopy is between 34 and 67 % with a national average of 49 % of patients with detected adenomas. Due to the known adenoma miss rate in standard screening colonoscopies, it is important to increase the ADR on average as well as finding ways to improve ADR for centres with a lower than average ADR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
It is partially blinded in the way that the endoscopist knows whether the procedure is performed with or without the EndoRings but neither patient, pathologist nor investigators will have this information, which is only to be revealed to the investigators at the end of data processing.
入排标准
- 年龄范围
- 50 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients meeting all the below listed criteria are eligible for inclusion in the trial:
- •Age between 50 - 74 years (age range of screening population)
- •Positive HemoCult home test from the Danish Colorectal Cancer Screening Programme
- •Ability to give informed consent to participation in the trial.
排除标准
- •Patients meeting one or more of the below listed criteria will be excluded from the trial:
- •History of colorectal cancer
- •History of Inflammatory Bowel Disease
- •Part of other control programme (e.g. HNPCC or adenoma control)
- •ASA =/> 4 and/or necessity of general anaesthesia
- •Former surgery with removal of a part of the colon on either benign or malignant background
研究组 & 干预措施
With EndoRings
Colonoscopy is performed with the use of the cap-device EndoRings II Distal Attachment to be attached to the tip of the colonoscope
干预措施: EndoRings II Distal Attachment (Device)
NO EndoRings
Colonoscopy is performed conventionally without any caps
结局指标
主要结局
Adenoma detection rate
时间窗: maximum 60 minutes
Number of colorectal adenomas/neoplasms/carcinomas found in colonoscopy
次要结局
- Completion time(maximum 60 minutes)
- Completion rate(maximum 60 minutes)
- Malignancy detection(maximum 60 minutes)