Impacts of Inspection During Instrument Insertion on Colonoscopy Quality: a Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 428
- 试验地点
- 2
- 主要终点
- Percentage of Participants With Detection of at Least One Adenoma Per Procedure
研究概览
简要总结
Small colon polyps which are found during colonoscopy insertion are sometimes difficult to find during withdrawal and thus missed. The investigators aim to evaluate the differences of colon polyp/adenoma detection rates of patients undergoing additional inspection and polypectomy during insertion as compared to the patients undergoing traditional practice of careful inspection and polypectomy performed entirely during withdrawal of colonoscopy.
详细描述
Participants will be randomly assigned by a research assistant, by using a computer-generated randomization sequence to undergo colonoscopy with either inspection and polypectomy during both insertion and withdrawal of colonoscope (study group) or inspection and polypecotmy entirely during withdrawal of colonoscope (control group). Randomization will be done via concealed allocation with a sealed envelope that designate study group or control group.
Colonoscopies will be performed by two experienced investigators by using a standard colonoscopy (CF-Q260AI or CF-Q260AL; Olympus Medical Systems Corp., Tokyo, Japan). All procedures are performed under moderate conscious sedation with fentanyl (United Biomedical, Taipei, Taiwan) and midazolam (Dormicum; Roche Pharmaceuticals, Basel, Switzerland) according to the current guidelines. Carbon dioxide insufflation is used for all endoscopic procedures. All participants receive 3-L polyethylene glycol (PEG; Klean-Prep, Helsinn Birex Pharmaceuticals Ltd., Dublin, Ireland) for bowel preparation. A split-dose of the PEG preparation is provided. The level of colon cleansing is prospectively evaluated with the Boston Bowel Preparation Scale score.
For participants assigned into the study group, the colonic lumen is washed with saline and the fluid and debris are suctioned as the instrument is slowly inserted from rectum to cecum. Deliberate and systematic inspection of the colonic mucosa is performed with adequate luminal insufflations during both the insertion and withdrawal phases. Polyp size is determined by comparison with open colonoscopic biopsy forceps pushed against the polyp or, in some cases of pedunculated polyp by direct measurement after retrieval. Polyps with size <10mm are removed as they are identified on insertion and withdrawal. Polyps with size ≥10mm are removed only during withdrawal.
For participants assigned into the control group, deliberate mucosal inspection and polyp removal are performed exclusively on instrument withdrawal. During insertion, minimal mucosal inspection and insufflation are applied to efficiently advance the instrument into cecum. If a polyp is found during insertion, investigators are instructed to make a mental note of it and find it during withdrawal for polypectomy.
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 (Participant)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 45 years or older.
- •Agree to participate the study and provide a written informed consent
排除标准
- •Previous surgical resection of the colon or rectum
- •Inflammatory bowel disease
- •Polyposis syndrome
- •Previously incomplete colonoscopy
- •Obstructive lesions of colon
- •Inadequate bowel preparation, defined as Boston Bowel Preparation Scale score of 0 or 1 in any colon segment
- •Gastrointestinal bleeding
- •Allergy to fentanyl or midazolam
- •American Society of Anesthesiology classification of physical status 3 or higher
- •Mental retardation
- •Pregnancy
- •Refusal to provide a written informed consent
研究组 & 干预措施
Insertion/withdrawal colon polypectomy
For participants assigned in the experimental group, the colon is washed and the debris is suctioned as the colonoscopy is slowly inserted from rectum to cecum. Deliberate and systematic inspection of the mucosa is performed with adequate insufflation during both insertion and withdrawal phases.Colon polypectomy for polyp size <10 mm will be performed when they are identified during insertion and withdrawal of the colonoscope. Colon polypectomy for polyp size >10 mm will be performed only during withdrawal of the scope.
干预措施: Colon polypectomy (Procedure)
Withdrawal colon polypectomy
For participants assigned in the control group, deliberate mucosa inspection and colon polypectomy will be performed exclusively on colonoscopy withdrawal.During insertion, minimal mucosal inspection and insufflation are applied to efficiently advance the instrument into cecum.
干预措施: Colon polypectomy (Procedure)
结局指标
主要结局
Percentage of Participants With Detection of at Least One Adenoma Per Procedure
时间窗: During procedure, approximately one hour
Colon adenoma detection rate is defined as the proportion of colonoscopies where at least one adenoma is found.
次要结局
- Mean Colon Adenoma Per Colonoscopy(During procedure, approximately one hour)
研究者
Chi-Liang Cheng
Director of Gastroenterology
Evergreen General Hospital, Taiwan