Prospective RCT of Water Exchange (WE) vs. WE Plus Cap-Assisted Colonoscopy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 280
- 试验地点
- 6
- 主要终点
- Real Time Maximum Insertion Pain
研究概览
简要总结
This is a study to compare two different, but normally, used methods of colonoscopy in patients undergoing colonoscopy without sedation. There will be two arms in this study: WE (water exchange) control, and WE (water exchange) plus cap (placed at tip of the colonoscope). The patient will prepare himself/herself for the colonoscopy as per normal instructions and he/she will be given the information for the study at that time so that he/she can make a decision to participate in the study. The control method will use water instead of air during insertion of the colonoscope. The study method will use a cap that will fit onto the end of the colonoscope plus water during insertion of the colonoscope. This study will assess if the study method is less painful than the control method.
详细描述
This will be a multi-VA site, unblinded investigators, prospective randomized control trial (RCT). Randomization (WE, WE + cap) will be based on computer generated random numbers placed inside opaque sealed envelopes. The envelope (in pre-arranged order set up by statistics consultant) will be opened to reveal the code when the colonoscopist is ready to insert the endoscope to begin the examination. This will be a comparison of two arms (WE, WE + cap) to see which one is less painful.
Patients who are willing to participate will sign an informed consent before starting the colonoscopy procedure. Separate parallel randomization will be set up at each site, stratified type of colonoscopy (screening, surveillance, diagnostic). All subjects will have scheduled unsedated colonoscopy as a result of lack of escort or personal preference for no sedation. Randomization will be set up by statistics consultant.
Control Method: One arm of the study will include unsedated colonoscopy with water exchange (WE) as the control method. Residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water will be removed by suction, along with residual fecal debris, predominantly during insertion.
Study method: The other arm will include unsedated colonoscopy with water exchange (WE) and the addition of a cap, fitted to the colonoscope per manufacturer instruction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Informed/educated (about pros and cons of the unsedated option) Veterans undergoing:
- •diagnostic
- •surveillance (follow up of polyps)
- •screening (first-time) colonoscopy at participating sites
- •choosing scheduled unsedated colonoscopy for any reason (lack of escort, personal preference)
排除标准
- •decline to be randomized
- •unable to give consent or respond to questionnaires
- •history of colon surgery
- •active inflammatory bowel disease
- •lower gastrointestinal bleeding (except for occult blood or FIT positive in the context of colon cancer screening)
- •therapeutic colonoscopy (e.g., hemostasis, removal of large polyp)
- •proctosigmoidoscopy
- •bidirectional endoscopy
- •inadequate consumption of bowel preparation
- •known history of severe diverticulosis or diverticulitis
- •history of abdominal surgery previously requiring sedation for colonoscopy
- •current narcotic/anxiolytic medication use
- •prior unsuccessful experience with unsedated colonoscopy
- •emergent colonoscopy
- •evidence of colonic obstruction based on pre-colonoscopy clinical evaluation
- •current participation in other studies
- •medical condition that could increase the risk associated with colonoscopy
- •active cardiac
- •or pulmonary disease
- •or other serious disease
- •medical condition that would preclude a benefit from colonoscopic screening
- •or any terminal illness
- •prosthetic heart valve
- •anticoagulant therapy
- •nonmedical problems
- •psychiatric disorders
- •excessive use of alcohol
- •need for special precautions in performing colonoscopy
- •antibiotic prophylaxis
- •request of on demand sedation
结局指标
主要结局
Real Time Maximum Insertion Pain
时间窗: Insertion pain was measured during the duration of the colonoscopy procedure, which lasted on average for about 1 hour
Pain during insertion reported to the unblinded assisting nurse, visual analogue scale, VAS: 0=none, 10=most severe. The highest pain score will be tabulated for analysis. Timing of data collection will be at the discretion of the nurse to minimize bias by colonoscopist behavior.
次要结局
- Insertion Time(Insertion time in minutes was measured during the duration of the colonoscopy procedure, which lasted on average for about 1 hour)
- Right Colon Adenoma Detection Rate (ADR)(Adenoma Detection Rate (ADR) was measured during the duration of the colonoscopy procedure, which lasted on average for about 1 hour)
- Proportion of Patients With No Insertion Pain(Pain was measured during the duration of the colonoscopy procedure, which lasted on average for about 1 hour)