Comparison of Efficacy and Patient Tolerability of Four Commercially Available Bowel Purgatives for Screening and Surveillance Colonoscopy: A Single Tertiary Medical Center Experience.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Efficacy of bowel cleansing according to the Boston Bowel Preparation Score (BPPS)
研究概览
简要总结
This will be a 4-way comparison to prospectively evaluate the efficacy and patient tolerability of four commercially available bowel preparations among patients undergoing colonoscopy for screening and surveillance in a single tertiary academic medical center.
详细描述
We will randomize 300 consecutive patients undergoing colonoscopy for screening or surveillance purposes to receive one of four bowel purgatives. These purgatives include
- Split dose 4 liter polyethylene glycol with electrolytes (PEG+E): Brand name GoLytely
- Split dose 2 liter polyethylene glycol with ascorbic acid (PEG+Asc): Brand name: MoviPrep
- Split dose sodium picosulfate, magnesium oxide, and anhydrous citric acid (P+MC): Brand name Prepopik
- Split dose sodium sulfate, magnesium sulfate, and potassium sulfate solution (sulfate): Brand name Suprep
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or greater
- •Ability to understand and complete questionnaires
- •Ability to speak and read English
- •Willingness to participate in study
- •Colonoscopy is being performed for routine screening (i.e. no prior personal history of polyps or cancer) or surveillance (i.e. follow up for a personal history of polyps) purposes
排除标准
- •Previous bowel resection of any kind (small or large bowel)
- •End stage renal disease (ESRD)
- •Contraindication to bowel purgative
- •Necessity for inpatient admission to receive bowel preparation for any reason
- •Currently taking any narcotic/opiate pain or anticholinergic medication (since these may predispose to higher colon stool burden at baseline)
- •Currently taking stool softeners (e.g. Miralax, Amitiza, Linzess, lactulose) or stimulant laxatives (e.g. Dulcolax)
- •Subject did not follow appropriate dosing instructions for bowel purgative
- •Colonoscopy is being performed to evaluate a clinical symptom such as rectal bleeding, constipation, abdominal pain, or diarrhea
- •History of colon polyposis syndrome
- •Personal history of inflammatory bowel disease
- •History of inadequate colon preparation on any prior colonoscopies
- •Patient is pregnant
研究组 & 干预措施
PEG+E
Split dose 4 liter polyethylene glycol with electrolytes
干预措施: PEG+E (Drug)
PEG+Asc
Split dose 2 liter polyethylene glycol with ascorbic acid
干预措施: PEG+Asc (Drug)
P+MC
Split dose sodium picosulfate, magnesium oxide, and anhydrous citric acid
干预措施: P+MC (Drug)
sulfate
Split dose sodium sulfate, magnesium sulfate, and potassium sulfate solution
干预措施: sulfate (Drug)
结局指标
主要结局
Efficacy of bowel cleansing according to the Boston Bowel Preparation Score (BPPS)
时间窗: Patient outcome will be assessed at the time of the colonoscopy by the performing physician and ducomentation of this outcome will occur within 24 hours of the procedure
次要结局
- Patient tolerability and satisfaction(Outcome of satisfaction will be assessed on a single survey that the patient will provide the day of their colonoscopy and will be recorded by study personnel up to 30 days thereafter)
研究者
Zachary Smith
Division of Gastroenterology
Medical College of Wisconsin