Patient Position and Impact on Colonoscopic Cecal Intubation Time
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Colonoscopic Cecal Intubation time
研究概览
简要总结
Colonoscopy is usually associated with coiling ("looping") of the colonoscope (instrument used for the procedure) in parts of the bowel. This is the main reason for patient discomfort and lengthens the duration of the procedure. Minimizing the coiling of the colonoscope would decrease the duration, and improve the efficiency and tolerability of the procedure and have a positive impact on colon cancer screening.
The primary aim of this study is to compare the time it takes for the colonoscope to reach the end of the colon when the patient is lying on the belly versus the left side (usual) at the start of the procedure. Patients who have medical conditions that may be affected by lying on their belly or those who cannot comfortably lie on the belly will be excluded from the study. Changes in patient position and use of abdominal pressure (commonly given by the endoscopy nurse during the procedure) will be permitted as necessary and determined by the endoscopist. The endoscopist will also retain the decision to discontinue the patient's participation from the study for any medical reason. After the procedure the patient will be monitored in the usual manner and asked to fill out a "satisfaction survey" (24 hours after).
详细描述
1. Principal investigator: Shivakumar Vignesh MD, Gastroenterology Attending Physician, VACHS
Colonoscopy with the patient in the prone position may reduce colonoscopy duration and may reduce patient discomfort by a reduction in coiling of the colonoscope with a mobile part of the bowel, decreased need for abdominal pressure and less sedation may improve the safety and efficacy of colonoscopy.
Objective: To determine if starting colonoscopy with the patient in the prone position will reduce cecal intubation time (time to reach the cecum) and total sedation requirement.
Subjects: 120 adult male, patients referred of outpatient colonoscopy will be the study subjects and controls. We do 15-18 colonoscopies a day and assuming half that number meet criteria for inclusion and consent to the study we will be able to recruit 120 patients in 6 months or less. Our records indicate more than 1000 colonoscopies are performed in a six-month period. If we conservatively estimate 10% ineligible patients > (n=900 remaining), 50% refusal (n=450 remaining), and enrollment on 4 of 5 weekdays (n=360 remaining), the six-month period would provide adequate sample size. The study would end if the target sample size is reached early.
Inclusion criteria: All adult, male patients presenting for outpatient colonoscopy. Patients who have had colonoscopies in the past and those who present for their first colonoscopy will be invited to participate in the study. It will not matter if it is their first or repeat colonoscopy as they will be randomized to either position.
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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male Veterans presenting for outpatient colonoscopy for any indication.
排除标准
- •Severe Congestive heart failure with left Ventricular ejection fraction <30%,
- •Severe Chronic Obstructive lung disease dependant on Home Oxygen or recent decompensation,
- •Spine disease or other condition with difficulty laying in the prone position.
结局指标
主要结局
Colonoscopic Cecal Intubation time
次要结局
- Total colonoscopy time, colonoscope withdrawal time, cumulative sedation dose, recovery time, need for abdominal pressure and changes in patient position during the procedure, adenoma prevalence rate, complications, patient satisfaction.