Randomized Control Trial Comparing the Incidence of Loop Formation in Water Infusion Versus Air Insufflation Colonoscopy Techniques
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 142
- 主要终点
- Number and type of colonscopy loops formed
研究概览
简要总结
A colonoscopy is a common procedure used to check for problems in the colon, such as disease or other health issues. Although it's widely used, one challenge is that the flexible tube used in the procedure (called a colonoscope) can sometimes form loops inside the colon. When this happens, pushing the tube further doesn't help it move forward-it just makes the loop bigger, which can make the procedure harder to complete. These loops can also cause more pain for the patient, require more sedation (medication to relax or put the patient to sleep), and increase the time it takes to finish the procedure. Because of this, it's important to find ways to reduce loop formation. Two common methods used in colonoscopies are called air insufflation and water infusion.
This study will compare the two methods-air vs. water-to see which one causes fewer loops. It will be a randomized controlled trial, meaning participants will be randomly assigned to one of the two methods. The study will involve real patients, and the data will be collected by physicians, residents (doctors in training), and medical students. During the colonoscopies, images from a tool that guides the scope will be recorded on video.
Experienced staff doctors and surgical residents (with at least two months of special training in this procedure) will perform the colonoscopies. Each procedure will be supervised by a team member, such as a medical student, resident, or staff doctor. Afterward, two reviewers who don't know which method was used will watch the videos to look for any loops. They will look for specific types of loops, including n, alpha, reverse alpha, reverse splenic, and gamma loops.
The study will also track how long it takes to reach the end of the colon (called the cecum), how comfortable the patient was (using a standard rating system already used in all colonoscopies), and how much sedation was needed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Consenting patients who are undergoing a routine colonoscopy.
- •Ages between 18-80 years old.
排除标准
- •Refusal to participate
- •Inability to provide informed consent.
- •History of prior colonic surgery.
- •Poor bowel preparation.
- •Known bowel obstruction.
- •Emergency colonoscopy.
研究组 & 干预措施
Colonoscopy with water insufflation
Colonoscopy performed using just water to inflate the colon
干预措施: colonoscopy (Diagnostic Test)
Colonoscopy with air insufflation
Colonoscopy performed using just air to inflate the colon
干预措施: colonoscopy (Diagnostic Test)
结局指标
主要结局
Number and type of colonscopy loops formed
时间窗: 12 months
The number and type of different colonoscopy loops formed during each colonoscopy will be recorded from the initial insertion of the colonoscope to complete removal of the colonoscope of each colonoscopy.
Number and type of colonscopy loops formed
时间窗: 12 months
The number and type of different colonoscopy loops formed during each colonoscopy will be recorded from the initial insertion of the colonoscope to complete removal of the colonoscope of each colonoscopy.
次要结局
未报告次要终点
研究者
David Pace
Dr. Davis Pace
Memorial University of Newfoundland
