Colonoscopy Bowel Prep Comparison Among Diabetic Patients: Golytely v. SUPREP
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Bowel cleanliness using the Boston Bowel Prep Score (BBPS)
研究概览
简要总结
The goal of this clinical trial is to learn if the Golytely or SUPREP bowel preparation works more effectively in bowel cleansing for colorectal cancer screening with colonoscopy in patients with diabetes. The main questions this study aims to answer are:
- Is there a significant difference in bowel prep cleanse between Golytely and SUPREP in patients with diabetes based on the Boston Bowel Prep Score (BBPS) as assessed by blinded, skilled endoscopists?
- Is there a significant difference in patients' tolerance between the bowel preparations as assessed by the validated Mayo Bowel Prep Tolerability Form (MBPTF)?
Participants will:
- Be randomized to take either Golytely or SUPREP bowel preparation prior to their colonoscopy
- Complete the MBPTF on the procedure date prior to the scheduled colonoscopy
- Undergo a standardized screening colonoscopy during which time a blinded endoscopist will document the participant's BBPS
The research team hypothesizes that SUPREP will have a significant difference in tolerability (based on MBPTF), while exhibiting no difference in bowel cleanse (based on BBPS) in the diabetic patient population.
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
- Double (Care Provider, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants having provided informed consent with signature on informed consent form: the informed consent process should be complete with full discussion of all requirements and possible risks.
- •Diabetic volunteer (defined per current ACP guidelines, and any type of DM)
- •Aged 18+ years, inclusive
- •Average screening risk, polyp surveillance, and family history of cancer
排除标准
- •Unable to provide informed consent to participate in the study Such as a mental condition rendering the participant unable to understand the nature, scope, and possible consequences of the study
- •Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult or that would put the participant at risk by participating in the study
- •Persistent significant or severe infection, either acute or chronic
- •Prior use of any investigational drug in the preceding 6 months
- •Liver function impairment or persisting elevations (confirmed by retest) of alanine aminotransferase (ALT), aspartate aminotransferase (AST), or direct bilirubin greater than 2x the upper limit of normal range (ULN).
- •Pregnant or breast-feeding women or those who plan to become pregnant during the study
- •Participants with significantly impaired bone marrow function or significant anemia, leukopenia, or thrombocytopenia (confirmed by retest):
- •Hematocrit < 35% and/or
- •Absolute white blood cell count < 3000 cells/mm3 ( L) and/or
- •Platelet count < 150 000 cells/mm3 ( L) and/or- Absolute neutrophil = 1500 cells/mm3 ( L)
- •History of colorectal cancer
- •Inflammatory Bowel Disease
- •Past surgical history of colon resection
- •Prior history of colorectal surgery
- •Family history of hereditary polyposis and cancer disorders to include but not limited to FAP (Familial Adenomatous Polyposis), Gardner Syndrome, Turcot Syndrome, Lynch Syndrome, Cowden Syndrome, and Peutz-Jeghers Syndrome
- •Symptomatic patients (bleeding, diarrhea, constipation, abdominal pain)
研究组 & 干预措施
Diabetic patients undergoing bowel prep for screening colonoscopy using SUPREP
干预措施: SUPRPEP (Drug)
Diabetic patients undergoing bowel prep for screening colonoscopy using Golytely
干预措施: Golytely (Drug)
结局指标
主要结局
Bowel cleanliness using the Boston Bowel Prep Score (BBPS)
时间窗: Procedural (during the participant's screening colonoscopy)
The BBPS uses a score from 0-9 which helps quantify bowel cleanliness after bowel prep prior to colonoscopy. A higher score indicates better visualization of the colon mucosa. This will be assessed by blinded, skilled endoscopists.
Use of the Mayo Bowel Prep Tolerability Score (MTS)
时间窗: Pre-procedural (prior to the participant's screening colonoscopy)
The questionnaire is a validated scoring system used to assess the tolerability (ex. symptoms) and experience (ex. likelihood of using the bowel prep again) among diabetic patients undergoing the study.
次要结局
未报告次要终点
研究者
Darrell F. Barker, MD, FACG
Principal Investigator
Eisenhower Army Medical Center