The Effect of Mentholyptus Drops (Halls®) on the Palatability of PEG-Electrolyte Solution (FORTRANS®) in Colonoscopy Preparation: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- measurement of Palatability of the PEG-electrolyte solution
研究概览
简要总结
The investigators aim is to study the efficacy of mentholyptus drops in improving the palatability of PEG-electrolyte solution used in bowel cleansing for colonoscopy. The study is a randomized controlled trial which will include patients undergoing elective colonoscopy at the American University of Beirut Medical Center. Patients will be randomized into one of two study arms using a computer generated randomization list. Patients assigned to the intervention arm will be asked to have candy (Halls®) during the whole 2 hours period while drinking the PEG solution unlike the control arm patients who will only receive the PEG solution. All patients will then be evaluated for the tolerability of the preparation while taking into account the palatability of the solution as main outcome and the remaining volume of the PEG solution and side effects as secondary outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •elective colonoscopy
- •consent to the study
排除标准
- •pregnant or lactating women
- •age less than 18 years
- •significant gastroparesis
- •gastric outlet obstruction
- •known or suspected bowel obstruction or perforation
- •phenylketonuria
- •glucose-6-phosphate dehydrogenase deficiency
- •severe chronic renal failure (creatinine clearance <30 mL/minute)
- •severe congestive heart failure (NYHA class III or IV)
- •dehydration
- •severe acute inflammatory disease
- •compromised swallowing reflex or mental status
- •uncontrolled hypertension (systolic blood pressure ≥170 mm Hg, diastolic blood pressure ≥100 mm Hg)
- •toxic colitis or megacolon
- •previous colonoscopy within the last 5 years
- •active Inflammatory bowel disease
- •previous colectomy or partial colectomy
研究组 & 干预措施
Halls
every patient will drink 4 Liters of PEG solution (FORTRANS®) split into 2 days with sugar-free mentholyptus drops (2 L at 7-9 pm on the day prior to the colonoscopy with Halls®, and 2 L on the day of the colonoscopy to be completed a minimum of 1.5 hours before the procedure with Halls®).
干预措施: PEG solution (Fortrans®) and Mentholyptus Drops (Halls®) (Other)
no Halls
Every patient will drink 4 liters of PEG solution (FORTRANS®) split into 2 days (2 L at 7-9 pm on the day prior to the colonoscopy, and 2 L on the day of the colonoscopy to be completed a minimum of 1.5 hours before the procedure)
干预措施: PEG solution (Fortrans®) (Other)
结局指标
主要结局
measurement of Palatability of the PEG-electrolyte solution
时间窗: 1.5 hours after drinking the solution
patients will be asked to assess the palatability of the colon preparation solution (Fortrans®) by giving it a score on a scale from 1 to 5 with 1 being disgusting and 5 being tasty after drinking the whole solution and immediately prior to the colonoscopy
次要结局
- volume remaining of the colon preparation solution(1.5 hours after drinking the solution)
- Side effects(1.5 hours after drinking the solution)
研究者
Ala'a Sharara
Head and Professor, Division of Gastroenterology and Hepatology
American University of Beirut Medical Center