Clear Liquid vs Liberalized Diet in Preparation for Colonoscopy
试验速览
- 阶段
- 不适用
- 入组人数
- 1,000
- 主要终点
- Adenoma Detection Rate
研究概览
简要总结
Colorectal cancer is the third most common cancer diagnosed in both men and women in the United States. The death rate from this disease, however, has been decreasing over the last 20 years. Early detection and removal of pre-malignant polyps is considered to be at the core of this change. At the same time, polyp detection is highly dependent on an adequate bowel preparation. Froehlich, et al., found that poor bowel preparation is associated with longer colonoscopy times, more difficult procedures and a higher rate of incomplete procedures(2).
Although a Clear Liquid Diet is usually the prescribed diet in most bowel preparation regimes, several studies have shown similar results with less restrictive diets.
Based on the hypothesis that a Full Liquid Diet(FLD) is not inferior to a Clear Liquid Diet(CLD), investigators plan to conduct a prospective, randomized trial, in order to compare these dietary interventions. The investigators and endoscopists will be blinded to patient's diet group.
Researchers aim to investigate if diet liberalization to a Full Liquid Diet(FLD) is associated with similar bowel cleansing as compared with a Clear Liquid Diet(CLD). Investigators will compare the performance of these dietary interventions regarding adenoma detection rates(ADR), time to cecal intubation(TCI), and colonoscope withdrawal time. In addition, the investigators want to assess whether patient's Compliance and Satisfaction is similar or superior in the experimental group vs the control group.
详细描述
The purpose of this study is to investigate if a Full Liquid Diet is not inferior to a Clear Liquid Diet in preparation for Screening Colonoscopy. Based on the data presented above, the investigators hypothesize that a Full Liquid Diet will be better tolerated by participants and will not adversely affect colonoscopy outcomes in terms of bowel cleansing(BC), adenoma detection rate(ADR), time to cecal intubation(TCI).
The results of this study may help guide dietary interventions in preparation for Colonoscopy in the Department of Defense(DOD) Military Treatment Facilities.
The relationship between adequate colon cleansing and adenoma detection rate(ADR) has been already established. Almost 25% of patients, however, have a poor bowel preparation at the time of Colonoscopy(1). After reviewing 5832 colonoscopies, Froehlich, et al., found that poor bowel preparation is associated with longer colonoscopy times, more difficult procedures and a higher rate of incomplete procedures(2).
Among other causes, bowel cleansing is affected by purgative selection and timing of administration, compliance with recommended pre-procedural diet and compliance with purgative administration. Recently, it has been found that the classically recommended clear liquid diet(CLD) is not indispensable for adequate bowel prep. Stolpman, et. al, found that a low-residue diet is non-inferior to clear liquid diet(CLD), in a group of 201 patients(3). Similarly, Melicharkova, et al, found that the bowel cleansing efficacy of a low-residue breakfast, the day before colonoscopy, was comparable with a clear liquid diet(CLD) in a sample of 213 patients administered a low volume purgative in preparation for colonoscopy(4). They also found a statistically significant difference in the level of patient's acceptance of the low-residue diet.
A group from South Korea, led by Dr. Jung Yoon, found similar rates of bowel cleansing in patient undergoing afternoon colonoscopy, when offered Regular Diet(5). A study, in a small study population, presented as an abstract at the American College of Gastroenterology Conference in 2011, reported comparable bowel cleansing, polyp detection rate, and colonoscopy times in patients allowed a full liquid diet before the procedure(6). Taken together, these studies show that a clear liquid diet may not be necessary in order to obtain a good bowel cleanse in preparation for colonoscopies performed in the outpatient setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Asymptomatic patients 50 years old or older, undergoing screening colonoscopy and willing to participate in the study will be included, after obtaining informed/written consent.
排除标准
- •Symptomatic patients, patients with indications for therapeutic colonoscopy, like for example, rectal bleeding or with a prior diagnosis requiring evaluation with colonoscopy(Prior diagnosis of colon polyps, Iron-deficiency Anemia, Inflammatory Bowel Disease, Colorectal Cancer, Chronic diarrhea, Abnormal Imaging) will be excluded from participation. Please note that patients with Iron-deficiency Anemia will not be excluded from the study, based solely on this diagnosis, if they have an indication, otherwise, for Screening Colonoscopy.
结局指标
主要结局
Adenoma Detection Rate
时间窗: During Colonoscopy
Number of patients with at least one adenoma, divided by total number of patients aged 50 years or older screened with colonoscopy
Time to Cecal Intubation
时间窗: During Colonoscopy
Quality of Bowel Preparation
时间窗: At the time of Colonoscopy
This will be assessed using the Boston Bowel Preparation Scale
Colonoscope Withdrawal time
时间窗: During Colonoscopy
Time elapsed since the endoscopist starts withdrawing the colonoscope, after reaching the cecum, until the completion of the test.
次要结局
- Patient compliance(Before Colonoscopy)
- Patient satisfaction(Before Colonoscopy)
研究者
Luis X. Velez-Colon, MD
Gastroenterology Fellow(PGY5)
San Antonio Military Medical Center