1L Morning-only Polyethylene Glycol Plus Ascorbic Acid With Prepackaged Low-residue Diet Versus 2L Polyethylene Glycol Plus Ascorbic Acid for Bowel Preparation: a Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 主要终点
- Achievement of preparation adequacy
研究概览
简要总结
Background 2L polyethylene glycol plus ascorbic acid (PEGA) is known to be as effective as standard 4L polyethylene glycol for bowel preparation. However, the volume of this regimen is still large. Therefore, the present investigators evaluated the potential of 1L PEGA with prepackaged low-residue diet (PLD) for an alternative to 2L PEGA.
Aim: To evaluate efficacy of 1L PEG with ascorbic acid combined with prepackaged low-residue diet as bowel preparation for colonoscopy.
Methods: The subjects were randomly assigned to either groups. PEGA group received 2L PEGA split regimen. PLD group received PLD on the day preceding colonoscopy and 1L PEGA on the morning of colonoscopy. One blinded physician performed colonoscopy and evaluated the degree of bowel preparation using Boston bowel preparation score (BBPS). A questionnaire regarding tolerability and safety were also gathered.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
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
- •anyone who were scheduled for an outpatient colonoscopy below indication
- •patient who need colonic polyp screening
- •patient who have hematochezia
- •patient who have fecal occult blood test positive result
排除标准
- •inflammatory bowel disease-
- •gastrointestinal malignancy
- •severe cardiac disease (heart failure beyond NYHA Class III)
- •chronic obstructive pulmonary disease,
- •decompensated liver cirrhosis; coagulopathy
- •Female patients with pregnant or breastfeeding.
- •who use long-term use of sedative, anti-spasmodic, prokinetic, laxative or anti-diarrheal medications
研究组 & 干预措施
2 L PEG with ascorbic acid group
1 L PEG with ascorbic acid with PLD
干预措施: 1 L PEG with ascorbic acid with prepackaged, low residue diet (Procedure)
结局指标
主要结局
Achievement of preparation adequacy
时间窗: assessed at the colonoscopy day
Definition: Achievement of preparation adequacy was defined by as having BBPS scores of 2 or 3 for all colon segments. BBPS was measured by Physician who performing colonoscopy. To maintain precise evaluation, the physician participated in an online training program from www.cori.org/bbps. For each colon segment, BBPS preparation score ranged 0 to 3. Definition of BBPS are presented at www.cori.org/bbps
次要结局
- Tolerability and adverse events(assessed at the colonoscopy day)
研究者
Hyuk Yoon
Assistant professor
Seoul National University Bundang Hospital