Cleansing Options in Outpatient Setting to Improve Tolerance (COOP SIT) Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Patient Experience
研究概览
简要总结
The purpose of this research is to compare patient preferences for two bowel preparation options: low-volume tablets (Suflave/Sutab) versus the standard colon preparation using Golytely (polyethylene glycol). The study aims to enroll approximately 300 patients, who will be randomly assigned to one of the two preparation methods in a 2:1 ratio prior to their scheduled colonoscopy appointments. Surveys will be conducted both before and after the procedures.
This project will be conducted over a 12-month period and seeks to compare patient experience of both preparation methods in an outpatient setting. The study will evaluate the rate of preparation completion, patient satisfaction, tolerance of the solutions, and the endoscopic adequacy of each method.
Eligible participants are patients aged 18 or older with upcoming colonoscopy appointments who can provide informed consent in English or Spanish. There is no health risks associated with this study, as both bowel preparation methods are FDA-approved and commonly used in clinical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults over age of 18 years undergoing outpatient colonoscopy for various indications, ability to consent in English or Spanish. Patients will still be allowed to join if there is a history of colorectal cancer or previous surgery
排除标准
- •Patient is less than 18 years of age, any pregnant or nursing women, unable to consent, or patient is incarcerated.
研究组 & 干预措施
Golytely
GoLYTELY is a prescription medicine used by adults to clean the colon before a colonoscopy or barium enema X-ray examination. GoLYTELY cleans your colon by causing you to have diarrhea (loose stools). Cleaning your colon helps your healthcare provider see the inside of your colon more clearly during your colonoscopy. Drink reconstituted solution at a rate of 8 ounces every 10 minutes, until 4 liters are consumed, or rectal effluent is clear.
干预措施: Golytely (Drug)
Sulfave
Suflave is a combination, osmotic prescription laxative that may be used to cleanse the bowel in preparation for colonoscopy in adults. Suflave contains polyethylene glycol 3350, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride, and is supplied as a powder that is mixed with a low volume of water before consuming. It tastes like a lemon-lime sports drink. Drink 8 ounces of the solution every 15 minutes until the bottle is empty, and then drink an additional 16 ounces of water during the evening. One dose of Suflave is equal to one bottle plus one flavor-enhancing packet.
干预措施: Sulfave (Drug)
Sutab
SUTAB comes in a kit that contains two medication bottles and a cup for water. Each bottle contains 12 tablets (pills). You'll take 12 pills (one bottle) with water from the cup the night before your exam. Later that evening, drink two more cups of water. Fill the cup to the line each time. Then, six hours before your exam, repeat all three of those steps.
干预措施: Sutab (Drug)
结局指标
主要结局
Patient Experience
时间窗: Until the end of the study
Evaluate the patient experience of the two new colon prep options (low volume and tablets) versus conventional bowel prep in an out-patient setting.
Edoscopic Adequacy
时间窗: Until the end of the study
Assess endoscopic adequacy of the three bowel cleansing solutions
次要结局
- Rate of Completion(Until the end of the study)