Can Simple and Inexpensive Techniques Enhance Patient Comfort in Sedation-risk Free Screening and Surveillance Colonoscopy?
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- abdominal discomfort
研究概览
简要总结
Hypotheses
- Loading the sigmoid colon with warm water and warm water irrigation for dealing with spasm (Study Treatment) will significantly reduce the proportion of patients complaining of abdominal discomfort compared with no water loading and waiting for spasms to subside (Control Treatment). The median discomfort score reported by the patients will be significantly lower in the group receiving the Study Treatment than the group receiving Control Treatment. Hypothesis
- Exploratory hypothesis: There are differences in secondary outcome variables when patients managed by the Study and Control Treatments are compared. Co-variables affect the primary and secondary outcome variables.
详细描述
The purpose of the study is to conduct a RCT study to determine the effectiveness of loading the sigmoid colon with warm water and warm water irrigation for dealing with colonic spasms in enhancing patient abdominal comfort during unsedated colonoscopy. The specific aim is to compare Study Treatment of warm water loading and irrigation when spasms occur with Control Treatment of no water loading and waiting for spasms to subside. The proportion of patients complaining of abdominal discomfort and their discomfort score are the primary outcome variables. The secondary outcome variables and co-variables described below will be recorded in a prospective manner to ensure completeness of data collection. In preliminary clinical observation at VA Sepulveda ACC, 25 to 30% of VA patients accept colonoscopy without sedation. The goal of this study is to find ways of further reducing discomfort associated with unsedated colonoscopy.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Accepts adult healthy male and female patients
- •At least 18 years of age
- •In need of colonoscopy for screening or follow up of colonic polyps
- •Willing to consent and be randomized
排除标准
- •Patients receiving outpatient narcotic treatment
- •Patients who report excessive anxiety
- •Patients with moderate to severe abdominal discomfort
- •Unable to provide consent
- •Have poor bowel preparation
研究组 & 干预措施
Warm water loading of sigmoid colon
Warm water loading of sigmoid colon and irrigation when spasms occur.
干预措施: Warm water (Other)
Control
No water loading, only air and waiting for spasms to subside.
干预措施: Control (Other)
结局指标
主要结局
abdominal discomfort
时间窗: 30 days
Abdominal discomfort reported to a blinded observer 5-10 min after colonoscopy.
次要结局
- colonoscopy-related outcomes(30 days)
研究者
Felix W. Leung
Staff Physician
VA Greater Los Angeles Healthcare System