Cap Assisted Colonoscopy Enhances Quality Based Competency in Colonoscopy Among Trainees
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 219
- 试验地点
- 1
- 主要终点
- Number of Participants That Successfully Reached the Cecum Within 30 Minutes of Insertion
研究概览
简要总结
The purpose of this study is to identify if performing diagnostic colonoscopy with a small plastic cap attached to the camera will improve performance of colonoscopies by physician trainees.
详细描述
Training novice endoscopists to perform effective diagnostic colonoscopy is a central objective of Gastroenterology fellowship. Though there is no universal definition of competency, it is traditionally assessed with a combination of objective measures such as volume of procedures and subjective factors such as formal evaluations. As quality measures such as cecal intubation time, cecal intubation rate, and adenoma detection rate gain in importance in clinical practice, they should be increasingly incorporated as objectives into more formalized and objective training methodologies.
Indeed, though 140 colonoscopies have been suggested as a rough volume threshold needed for trainees to gain competence, evidence suggests that the number may actually be much higher when taking various objective quality measures into account.
Recent attention has turned to various measures to improve trainee performance such as computer simulation and magnetic endoscopy imaging. Along these lines, simple, effective, and economical measures are needed to improve trainee performance.
Cap assisted colonoscopy (CAC) is performed with the aid of a transparent inert cap attached to the distal end of the colonoscope. CAC allows close examination of mucosa proximal to flexures and haustral folds and prevents "red out" when closely approximated against mucosa, aiding in luminal orientation and examination. CAC has been shown to improve cecal intubation time, polyp detection rate, and adenoma detection rate in the hands of experienced practitioners. A handful of studies have also indicated that these benefits also extend to trainees, while another prospective study showed no improvement in cecal intubation rate.
The investigators hypothesize that cap assisted colonoscopy will result in significantly improved cecal intubation rate and time, as well as adenoma detection rate, among trainees when compared with standard non cap assisted colonoscopy in a large academic Gastroenterology training program in the United States.
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
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients undergoing colonoscopy by a novice endoscopist
排除标准
- •Age less than 18 years or greater than 90 years.
- •Pregnancy.
- •Prior surgical resection of colon or rectum.
- •Known obstructing colorectal tumors.
- •Severe hematochezia.
- •Diverticulitis within 1 month of procedure.
- •Clinical or radiological evidence of colonic obstruction or megacolon within 1 month of procedure.
- •Referral for endoscopic mucosal resection.
- •Unsedated colonoscopies.
- •Colonoscopies abandoned due to inadequate bowel prep or colonoscopies with Boston bowel prep score < 3.
研究组 & 干预措施
Cap Assisted Colonoscopy
The distal attachment cap is affixed to the colonoscope before every colonoscopy in this arm.
干预措施: Distal Attachment Cap (Device)
Standard Colonoscopy
Standard colonoscopy without the distal attachment cap is performed in this arm.
结局指标
主要结局
Number of Participants That Successfully Reached the Cecum Within 30 Minutes of Insertion
时间窗: Each outcome measured during a complete colonoscopy. All colonoscopies performed during the initial 3 months of a 12 month training program
Proportion of all colonoscopies in which the trainee successfully reached the cecum within 30 minutes of insertion without the help of the attending physician.
次要结局
- Mean Time From the Moment of Colonoscope Insertion Until the Appendiceal Orifice or Ileocecal Valve is Identified(Each outcome measured during a complete colonoscopy. All colonoscopies performed during the initial 3 months of a 12 month training program)
- Number of Colonoscopies During Which at Least One Adenoma Was Identified(Each outcome measured during a complete colonoscopy. All colonoscopies performed during the initial 3 months of a 12 month training program)
- Number of Colonoscopies During Which at Least One Polyp Was Identified(Each outcome measured during a complete colonoscopy. All colonoscopies performed during the initial 3 months of a 12 month training program)
研究者
Kalpesh Patel
Assistant Professor
Baylor College of Medicine