A Prospective, Randomized Controlled Trial Comparing the Efficacy and Patient Tolerability of Miralax (PEG 3350) vs. Golytely as Bowel Preparation for Screening Colonoscopy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Boston Prep Scale
研究概览
简要总结
A major limitation to the widespread acceptance of colonoscopy as a procedure to screen for colorectal cancer is the laxative preparation. Phosphate-based preps (e.g. Fleets Phosphosoda) are now used on a limited basis because of their known association with renal injury. Polyethylene glycol (PEG) mixed with a balanced electrolyte solution (e.g. Golytely) has been used for over two decades for colon cleansing. The mixture is not very palatable due to the electrolyte additives which include sodium sulfate.
To overcome the limitation of existing preps, gastroenterologists and colorectal surgeons worldwide have been using PEG powder alone (same quantity as found in Golytely prep) not mixed with electrolytes (Glycolax or Miralax) and dissolving this into 64 ounces of Gatorade. Conservatively, we estimate that 25% of colonoscopies in the US are being done with this prep. Anecdotally there have been reports (case series) that it is far more palatable and the prep is equally efficacious. The active ingredient, PEG, is not changed and therefore this is not surprising. The issue at present is that there has never been a blinded study to confirm these claims.
This study will compare the efficacy of the two preps. There is no funding. The investigators will charge insurance companies for the prep - this is our current practice. The procedures will be done on healthy individuals referred for colon cancer screening and the exam will be billed to their insurance. There will be no patient honorarium. The investigators will check electrolytes to be sure patients do not develop hypokalemia with the Gatorade prep.
详细描述
Objective To determine whether Miralax is as efficacious for bowel cleansing as standard Golytely for screening colonoscopy. This study is designed and powered to be an non-inferiority study.
Primary aim: To compare the quality of bowel preparation between Miralax and Golytely
Secondary Aims:
- compare patient comfort and tolerability with each of the 2 preparation regimens
- evaluate the effects of age, gender and tolerability on bowel prep quality
- to determine if either preparation is associated with acute electrolyte disturbances
Background Colonoscopy is the standard method for luminal evaluation of the colon. Bowel cleansing prior to colonoscopy is critical to the endoscopist obtaining optimal visualization during the procedure and therefore plays an integral role in safety, efficacy and diagnostic accuracy of the procedure. The bowel cleansing portion of the procedure is often the most lamented aspect of the colonoscopy experience. This is often driven by the large volume of liquid required to be consumed, in addition to the poor palatability of some colon cleansing regimens. Cleansing methods are variable, and often times high volume solutions are time consuming, inconvenient and uncomfortable, leading to poor patient compliance. This translates into decreased effectiveness of the colonoscopy exam and often higher costs due to the need for repeat examination. Additionally, it is unknown how much the feared discomfort of the bowel preparation experience dissuades patients from pursuing a screening colonoscopy for colon cancer.
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
- Single (Investigator)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All adults undergoing average risk colon cancer screening (ages 40-75 years old)
- •Able to provide informed consent
排除标准
- •A history of constipation
- •Patients who use medications to assist with a bowel movement such as osmotic, stimulant, or cathartic laxatives (including "colon cleansers")
- •Diabetes or glucose intolerance
- •Patients with severe underlying renal or hepatic impairment
- •Pregnant women - pregnancy test performed on all menstruating women before procedure.
研究组 & 干预措施
Golytely 4 Liters
Golytely 4 Liters
干预措施: Golytely 4 liters (Drug)
PEG-3350 and Gatorade
255 miralax with 64 oz gatorade.
干预措施: PEG-3350 and Gatorade (Drug)
结局指标
主要结局
Boston Prep Scale
时间窗: photographs were taken throughout the colonoscopy and reviewed within 1 month after procedure.
The study is a non-inferiority study: The objective is to conclude that the prep quality scores of those receiving Miralax is at most 10% less than for Golytely. Thus the difference in prep scores between Miralax minus Golytely should be greater than - 10%. If this is the case, Miralax would be considered as non-inferior to Golytely. The outcome measure will use the Boston Prep Scale. The BPS is scored 0-9 with 9 being an excellent preparation throughout the colon. From the right colon, transverse colon , and left colon a score of 0-3 is given as follows and the total BPS is the arithmetic sum from each colon segment: 0 = Unprepared colon segment with mucosa not seen due to solid stool. 1. = Portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen. 2. = Minor amount of residual staining, small fragments of stool and/or opaque liquid 3. = clear colon without staining
次要结局
- Sodium Level in mmol/L(Day of procedure)
- Potassium Level in mmol/L(Day of procedure)
- Chloride Level in mmol/L(Day of procedure)
- Bicarbonate Level in mmol/L(Day of procedure)
- BUN Level in mg/dl(Day of procedure)
- Creatinine Level in mg/dl(Day of procedure)
- Glucose Level in mg/dl(Day of procedure)
- Calcium Level in mg/dl(Day of procedure)
- Magnesium Level in mg/dl(Day of procedure)
- Phosphorus Level in mg/dl(Day of procedure)