Investigation of Cecal Intubation Rates and Pain Levels Between Water Exchange and Air Insufflation Flexible Sigmoidoscopy: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 4
- 主要终点
- Full colon exam
研究概览
简要总结
This study evaluates how often patients without sedation that receive screening sigmoidoscopy are able to have their full colon examined without significant discomfort by comparing a new colonoscopy technique known as the water exchange technique to the traditional air insufflation technique. It compares the differences between complete colon exam rates for water exchange when compared to the traditional air technique. Patients will be randomised and blinded to the procedure type.
Previous studies have shown that the water exchange method is associated with a significant reduction in discomfort and often allows patients to receive colonoscopy without sedation or with only minimal sedation. However, the potential for water exchange to be used in the screening setting has yet to be evaluated. As per standard practices in sigmoidoscopy screening, patients will not be sedated. However, unlike standard practices in sigmoidoscopy screening, while maintaining minimal levels of discomfort, the investigators will attempt to scope beyond the distal colon.
详细描述
Purpose:
This study is being conducted to evaluate whether a new technique, known as the water exchange technique can more frequently allow for the full colon to be examined in patients undergoing screening sigmoidoscopy.*
Hypothesis & Goals & Objectives:
It is hypothesised that there will be a 20% or greater difference in cecal intubation rate (ability for the colonoscope to reach the Ileocecal juncture, and thereby provide full examination of the colon) at a minimal and acceptable level of discomfort in non-sedated colon screening patients receiving a scope using the water-exchange method, when compared to the air insufflation method.
Justification:
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, Investigator)
盲法说明
The study interviewer and the patient will be blinded to the procedure type both during and following the procedure type both during and following the procedure by concealing the monitors and relevant equipment from their sight.
The physician performing the procedure will be blinded to the procedure type until the patient is brought into the procedure room. They will open the allocation envelope once the patient has been placed and positioned on the procedure bed.
Neither the patient, the RN, nor the research assistant, who will be conducting the follow-up interviews, will be informed of the study arm. Patient assignment will be managed by the study project manager and will be kept in a password protected file and will remain separate from other study data until the time of the final analysis.
入排标准
- 年龄范围
- 50 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Asymptomatic average risk (as per BC colon screening guidelines) individuals
- •Ages 50-74 years of age
排除标准
- •A sigmoidoscopy or colonoscopy within 10 years,
- •A FIT within 2 years,
- •Individuals classified with any high-risk screening criteria in accordance to the
- •BC colon screening guidelines including:
- •a personal history of adenoma,
- •a first degree relative that was diagnosed with colorectal cancer or multiple adenomas under the age of 60,
- •two or more first degree relatives with colorectal cancer at any age, longstanding inflammatory bowel diseases,
- •a family history of familial adenomatous polyposis or hereditary nonpolyposis colorectal cancer, - Individuals presenting with rectal pain, rectal bleeding, abdominal pain, or unintentional weight loss at the time of the examination.
结局指标
主要结局
Full colon exam
时间窗: Immediately following the procedure
Ability for patient to receive full exam of the colon with minimal discomfort
次要结局
- Recalled Discomfort(Immediately following the procedure)
- Adenoma detection rates(Immediately following the procedure)