A Low-residue Diet is a Good Option for Patients With PEG Based Colon Preparation: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 215
- 主要终点
- Quality of bowel colonoscopy preparation
研究概览
简要总结
This was a randomized, endoscopists' blinded comparison of bowel colonoscopy cleansing and tolerability of a prespecified low-residue diet compared with a clear liquid diet and Polyethylene Glycol bowel preparation. Outcome measures included efficacy of bowel preparation, patient preparation tolerability and side-effects.
详细描述
An adequate examination is dependent on the bowel colonoscopy cleansing of stool. There are many different colon preparations, however endoscopists traditionally recommend the patient remain on a clear liquid diet for at least 24 h prior to their colonoscopy to reduce continued residue inflow into the colon from the small bowel, in addition the large volume preparation with PEG. The most common problems leading to less than adequate colon cleansing include lack of compliance with the clear liquid diet and difficulty taking the large volume preparation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Care Provider)
盲法说明
This was a randomized, endoscopists' blinded comparison of bowel cleanising, tolerability and quality indicators for colonoscopy
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Out-patient scheduled for colonoscopy
排除标准
- •Subjects under 18 years of age
- •Pregnancy
- •Subjects with decompensated metabolic, renal, cardiac and psychiatric disease
- •Allergy to PEG
- •Refuse participation
研究组 & 干预措施
Clear Liquid Diet
110 subjects received clear liquid diet 24 hours before colonoscopy
干预措施: Clear Liquid Diet (Dietary Supplement)
Low-residue Diet
105 subjects received a prespecified low-residue diet 24 hours before colonoscopy
干预措施: Low-residue Diet (Dietary Supplement)
结局指标
主要结局
Quality of bowel colonoscopy preparation
时间窗: 1 day
The quality of cleansing was recorded using the Boston Bowel Preparation Scale (BBPS), a four-point scoring system applied to each of the three broad regions of the colon (right=cecum and ascending, transverse= including the hepatic and splenic flexures and left=descending, sigmoid and rectum) during withdrawal. The point was assigned as 0= unprepared to 3=entire mucosa of colon segment seen well with no residual staining. Successful colon cleansing was considered when BBPS were \>2 per segment.
次要结局
- Satisfaction(1 day)
- Tolerability(1 day)
研究者
FELIX IGNACIO TELLEZ AVILA
M.D., M.Sc., Ph. D
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran