A Randomized Prospective Trial Comparing Different Regimens of Polyethylene Glycol-based Lavage and Sodium Picosulphate With Magnesium Citrate in the Preparation of Patients for Colonoscopy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- the quality of the bowel preparation using the Ottawa bowel preparation scale (OBPS)
研究概览
简要总结
Adequate bowel cleansing is important for a completeness of colonoscopy and detection of colon polyps. Inadequate bowel preparation leads to longer duration of colonoscopy and obscured mucosal visualization resulting in missed lesions.
Bowel cleansing agents are simply classified into the large volume, iso-osmotic polyethylene glycol (PEG) based solutions or the small volume osmotically active agents, such as sodium picosulphate with magnesium citrate (SPMC).
There are rare reports that compare directly conventional polyethylene glycol (PEG) solution and sodium picosulphate with magnesium citrate (SPMC) for bowel preparation in korea.
The aim of this study is to compare the efficacy, safety, and tolerability of different regimens of SPMC and PEG solution.
详细描述
-
Study design: endoscopist-blinded, prospective, randomized controlled trial
-
Subjects
-
Entry criteria: Male or female patients, aged between18 and 75 years undergoing elective outpatient colonoscopy were eligible for the study.
-
Exclusion criteria:
gastrointestinal obstruction or perforation, toxic megacolon, severe uncontrolled inflammatory bowel disease, previous colorectal resection, congestive heart failure, recent acute myocardial infarction or unstable angina, uncontrolled arterial hypertension, renal insufficiency with glomerular filtration rate < 60 ml/minute/1.73 m2, liver cirrhosis or ascites, pregnancy, lactation, and history of hypersensitivity to any bowel cleansing agents. 3. Sampling design: Consecutive recruitment of consenting patients 4. Variables Predictor
- group 1 (same day PEG) received 4 L of PEG at 6 hours before procedure on the day of the colonoscopy
- group 2 (split PEG) received 2 L of PEG at 6:00 p.m the evening before colonoscopy and 2 L of PEG at 4-6 hours before procedure
- group 3 (SPMC 2) received one sachet of SPMC at 6 p.m the evening before colonoscopy and another sachet of SPMC at 4-6 hours before procedure;
- group 4 (SPMC 3) received one sachet of SPMC at 6 p.m and the other sachet at 9 p.m the evening before colonoscopy and another sachet at 4-6 hours before procedure.
- Primary Outcome: Quality of bowel preparation (Ottawa scale)
- Secondary Outcome: Tolerability, palatability, side effect of the cleansing agents
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients, aged between18 and 75 years undergoing elective outpatient colonoscopy were eligible for the study
排除标准
- •gastrointestinal obstruction or perforation, toxic megacolon, severe uncontrolled inflammatory bowel disease, previous colorectal resection, congestive heart failure, recent acute myocardial infarction or unstable angina, uncontrolled arterial hypertension, renal insufficiency with glomerular filtration rate < 60 ml/minute/1.73 m2, liver cirrhosis or ascites, pregnancy, lactation, and history of hypersensitivity to any bowel cleansing agents.
研究组 & 干预措施
Same day PEG
group 1 (same day PEG, N=50) received 4 L of PEG at 6 hours before procedure on the day of the colonoscopy
干预措施: Polyethylene glycol (Drug)
split PEG
group 2 (split PEG, N=50) received 2 L of PEG at 6:00 p.m the evening before colonoscopy and 2 L of PEG at 4-6 hours before procedure
干预措施: Polyethylene glycol (Drug)
SPMC 2
group 3 (SPMC 2, N=50) received one sachet of SPMC at 6 p.m the evening before colonoscopy and another sachet of SPMC at 4-6 hours before procedure
干预措施: Sodium picosulphate with magnesium citrate (Drug)
SPMC 3
group 4 (SPMC 3, N=50) received one sachet of SPMC at 6 p.m and the other sachet at 9 p.m the evening before colonoscopy and another sachet at 4-6 hours before procedure.
干预措施: Sodium picosulphate with magnesium citrate (Drug)
结局指标
主要结局
the quality of the bowel preparation using the Ottawa bowel preparation scale (OBPS)
时间窗: 20 minutes
Immediately following the colonoscopy, the endoscopist who were unaware of the preparation regimen scored the quality of the bowel preparation using the Ottawa bowel preparation scale (OBPS).
次要结局
- Completeness of the bowel preparation(30 minutes before the colonoscopy)
- the patient's tolerability(30 minutes before the colonoscopy)
- the side effects of the sodium picosulphate and magnesium citrate(1 hour before the colonoscopy)
研究者
Woo-Jin Lee
fellow
Korea University Anam Hospital