Different Bowel Preparations in CT Colonography: is Diet Necessary? A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- overall quality of bowel preparation using a 0-3 scale for each parameter (Homogeneity of solid-fluid fecal tagging, volume of residual fluid, colon distension).
研究概览
简要总结
The aim of this study is to compare a new regimen of reduced bowel preparation that does not include low fiber diet with another reduced bowel preparation including low-fiber diet.
详细描述
Bowel preparation should be safe and well tolerated by patients, particularly in a screening setting. For this reason, limited bowel preparations have been extensively investigated. Usually, they combine the use of low-fibre diet and faecal/fluid tagging. The ingestion of a positive contrast agent (either barium, iodine or a combination of the two),needed to differentiate stool or fluid residues from true colonic lesions, is now considered mandatory. A low-fibre diet has the aim of improving residue homogeneity and facilitates tagging; however, there aren't significative evidences at support. The aim of this study is to compare a new regimen of reduced bowel preparation that does not include low fiber diet with another reduced bowel preparation including low-fiber diet. Primary outcome is the overall quality of bowel preparation.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Asymptomatic patients (Screening Patients)
- •Symptomatic patients unwilling to undergo optical colonoscopy (Symptomatic Patients)
- •Patients with a previous incomplete optical colonoscopy.
排除标准
- •Allergy to Macrogol
- •Cognitive behavioral deficits
研究组 & 干预措施
Diet included
Diet is included in bowel preparation
干预措施: Diet (Procedure)
Diet included
Diet is included in bowel preparation
干预措施: Faecal Tagging (Drug)
Diet included
Diet is included in bowel preparation
干预措施: Bowel cleansing (Drug)
Diet included
Diet is included in bowel preparation
干预措施: CT colonography (Procedure)
Diet not included
Diet is not included in bowel preparation
干预措施: Faecal Tagging (Drug)
Diet not included
Diet is not included in bowel preparation
干预措施: Bowel cleansing (Drug)
Diet not included
Diet is not included in bowel preparation
干预措施: CT colonography (Procedure)
结局指标
主要结局
overall quality of bowel preparation using a 0-3 scale for each parameter (Homogeneity of solid-fluid fecal tagging, volume of residual fluid, colon distension).
时间窗: 1 day
the evaluation of overall quality of bowel preparation on CT colonography images including: homogeneity of tagging, presence of unmarked solid stool residues, the evaluation of volume of residual fluids and colon distention.
次要结局
- compliance of patients(1 day)
研究者
Davide Bellini
Medical Doctor
University of Roma La Sapienza