A Prospective Randomized Comparison of the Adenoma Detection Rate in Screening Colonoscopy With and Without a Disposable Cap (ENDOCUFF VISION®)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,382
- 试验地点
- 9
- 主要终点
- Adenoma Detection Rate (ADR) in the two study groups
研究概览
简要总结
The aim of this study is to evaluate the effect of ENDOCUFF VISION® (caps with soft, about 1 cm long lateral feet of rubber ("Endocuff") to flatten the colon folds) on ADR in a real-life setting (general practices) and in a homogenous patient collective (screening colonoscopies only).
It is a prospective randomized multi centric study, with participation of at least 10 study sites (private practice). The study is an inverstigator-initiated trial (IIT).
Depending on the randomization (closed envelope), the patients are examined with the standard instruments without or with ENDOCUFF VISION®.
Group 1: screening colonoscopy with standard colonoscopes with ENDOCUFF VISION® Group 2: screening colonoscopy with standard colonoscopes without cap
详细描述
Colonoscopy is currently the best method for the detection of colon carcinomas and, as precursor, adenomas, since these can also be biopsied and removed. Therefore, the screening colonoscopy was introduced at the end of 2002 (covered by state insurance) from the age of 55. The main quality parameter for outcome quality is the adenoma detection rate (ADR), which correlates with the rate of the carcinomas prevented. However, since even smaller polyps, especially if they are flat or sunken, may be relevant for colon cancer development, the aim of colonoscopy should be to be able to recognize and remove as many adenomas as possible. There is a need to optimize the efficiency of screening colonoscopy by increasing the rate of adenoma detection, as it is known from many studies that approximately 15-30% of adenomas can be missed- even though the adenoma rate in the German screening colonoscopy register continues to increase over the years and currently stands at 28%.
Previous studies on the increase of the adenoma detection rate by endoscopy concerning newer endoscope technologies including conventional caps have been almost entirely negative.
For about 2 years, a newer version of ENDOCUFF VISION® caps (caps with soft, about 1 cm long lateral feet of rubber (Endocuff) to flatten the colon folds) is available which has already been used in about 8,000 colonoscopies in Germany and another 10,000 colonoscopies in Europe; there are no studies on this version of Endocuff caps.
The aim of this study is to evaluate the effect of ENDOCUFF VISION® in a real-life setting (general practices) and in a homogenous patient collective (screening colonoscopies only).
It is a prospective randomized multi centric study, with participation of at least 10 study sites (private practice). The study is an inverstigator-initiated trial (IIT).
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
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •> 55 years
- •who voluntarily undergo a screening colonoscopy
- •information and signed declaration of consent
排除标准
- •symptoms that may indicate a colonic disease
- •rectal/colonic bleeding
- •known colon disease for further diagnosis, e.g. Carcinoma, polyps for erosion, inflammatory bowel disease, stenosis
- •follow-up/surveillance after colon carcinoma surgery or polypectomy
- •anticoagulant drugs that make a biopsy or polypectomy impossible
- •poor general condition (from ASA (American Society of Anesthesiologists Classification) III)
- •partial/incomplete colonoscopy planned
结局指标
主要结局
Adenoma Detection Rate (ADR) in the two study groups
时间窗: through study completion, an average of 1 year
Differences in ADR with or without the new disposable ENDOCUFF VISION® cap. Hypothesis: Endocuff Vision improves the adenoma detection rate (ADR) by about 25% compared to the comparison group.
次要结局
- assessment of adenoma subgroups by form(12 months)
- ADR (all adenoma/all patients)(12 months)
- assessment of adenoma subgroups by size(12 months)
- procedure technique(through study completion, an average of 1 year)
- assessment of adenoma subgroups by location(12 months)
- assessment of adenoma subgroups by adjustability(12 months)
- assessment of adenoma subgroups by resection practice(12 months)
- assessment of adenoma subgroups by histology(12 months)
- Intervention times(through study completion, an average of 1 year)
研究者
Prof. Dr. Thomas Rösch
Prof. Dr. med.
Universitätsklinikum Hamburg-Eppendorf