NCT07127354招募中4 期
The Impact of GLP-1 Agonist and GIP Agonist on Bowel Preparation Quality: A Randomized Controlled Trial
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 132
- 试验地点
- 2
- 主要终点
- Rate of inadequate bowel preparation
研究概览
简要总结
The goal of this clinical trial is to learn how GLP-1 and GIP agonists effect bowel preparation in patients scheduled for colonoscopies. The main questions it aims to answer are:
- Does GLP-1 and GIP agonist increase the rate of inadequate bowel preparation?
- Does the quality of bowel preparation differ in patients who hold vs. those who continue a single dose of their GLP-1 or GIP agonist medication?
- Are there any differences in the rates of complications gastric aspiration in patients who hold vs. continue a single dose of their GLP-1 or GIP agonist medication?
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
- Double (Care Provider, Investigator)
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
- •Adult patient (Age 18 years or older)
- •Patient scheduled for outpatient screening, surveillance, or diagnostic colonoscopy
- •Using a GLP-1 or GIP agonist at a stable dose for at least one month
排除标准
- •Unable to provide informed consent, e.g., dementia
- •Patient refuses the USMSTF recommended bowel cleansing regimen for patients with diabetes or obesity (split-dose 4 liters polyethylene glycol + 15 mg bisacodyl the afternoon before; low residue diet 3 days before colonoscopy; clear liquid diet the day before colonoscopy)
- •Risk factors for inadequate bowel preparation besides diabetes and obesity with a likelihood ratio of 1.6 or greater:
- •Parkinson's disease
- •Tricyclic antidepressant use
- •Gastroparesis* or suspected gastric outlet obstruction on pre-procedure imaging (*defined based on a documented 4-hour solid phase gastric emptying study or prior history of retained gastric contents during upper endoscopy)
- •Previous colorectal surgery
- •Prior history of inadequate bowel preparation
研究组 & 干预措施
Continue GLP/GIP medication
Active Comparator
Patient maintains dose, frequency, duration of medication prior to colonoscopy.
干预措施: Continue GLP/GIP (Drug)
结局指标
主要结局
Rate of inadequate bowel preparation
时间窗: During Surgery
次要结局
- Rate of unplanned endotracheal intubation(During Surgery)
- Adenoma detection rate(During Surgery)
- Median Boston bowel prep score(During Surgery)
- Colonoscope Insertion time(During Surgery)
- Withdrawal time(During Surgery)
- Total procedure time(During Surgery)
- Median Ottawa bowel preparation score(During Surgery)
- hospitalization/emergency department evaluation/readmission for hypoxia or pnemonia within 96 hours after the procedure(From the day of the procedure to 96 hours after the procedure)
- Other serious adverse events(Day of the procedure up to 96 hours after the procedure.)
研究者
Shah,Tilak
Principal Investigator
The Cleveland Clinic
研究点 (2)
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