Efficacy and Tolerability of Morning (AM) Only Low Volume (2L) PEG With Low Residue Test Meals Versus High Volume (4L) Split-dose (PM/AM) PEG Bowel Preparation With Standard Meals: A Prospective Randomized, Investigator Blinded Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 188
- 试验地点
- 1
- 主要终点
- Quality of bowel preparation
研究概览
简要总结
Morning only low volume PEG with low reside meals may enhance patient tolerability and have similar bowel cleansing efficacy compared to standard method using high volume split-dose PEG with standard diet.
详细描述
We aimed to evaluate the efficacy and tolerability of bowel preparation protocols with low volume PEG and low residue meals PEG compared to conventional high volume (4L) split-dose and standard diet.
Entry criteria: Entry criteria: Adult outpatients and inpatients (18-85 years of age) who undergo colonoscopy for screening, cancer surveillance or with gastrointestinal symptoms, other symptoms
Primary Outcome: Quality of bowel preparation (Ottawa scale) Secondary Outcome: Tolerability (preparation completion, side effect), acceptance, willingness
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult outpatients and inpatients (18-85 years of age) who undergo colonoscopy for screening, cancer surveillance or with gastrointestinal symptoms, other symptoms
排除标准
- •Age under 18 years
- •Pregnancy
- •Breast feeding
- •Prior history of surgical large bowel resection
- •Severe medical condition such as severe cardiac
- •Hepatic, renal failure (creatinine ≥ 3.0mg/dL (normal 0.8-1.4))
- •Drug addiction or major psychiatric illness
- •Suspected bowel obstruction or ileus
- •Allergy to PEG
- •Refusal of consent to participate in the study.
研究组 & 干预措施
High volume PEG
Patients who are scheduled colonoscopy ingest high volume PEG(4L) for bowel preparation.
干预措施: high volume PEG (Drug)
Low volume PEG with low residual meals
Patients who are scheduled colonoscopy ingest low volume PEG(2L) and have a prepackaged low residual meals for bowel preparation.
干预措施: Low volume PEG (Drug)
结局指标
主要结局
Quality of bowel preparation
时间窗: 2 months
Quality of bowel preparation is assessed using Ottawa bowel preparation scale.
次要结局
- Tolerability(2 months)
研究者
Eun Hee Seo, MD
Principal investigator
Inje University