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临床试验/NCT03410524
NCT03410524已完成3 期

Simethicone Pretreatment With Low-volume Polyethylene Glycol-3350 and Bisacodyl in an Effort to Improve Bowel Wall Visualization During Colonoscopy

University of Nevada, Reno2 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2018年1月9日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
250
试验地点
2
主要终点
Intraluminal Bubbles Scale

研究概览

简要总结

An adequate bowel preparation has been well established to lead to a successful colonoscopy. Research has consistently demonstrated inadequate bowel preparation with lower adenoma detection rates. Over the years, endoscopy centers have changed the constituents of bowel preparation in light of new research. In 2006, 3 medical organizations recommended the use of polyethylene glycol (PEG) solution for bowel preparation. Initially, a 4 liter PEG solution was commonly used using a split dose regimen for bowel prep. However, many patients found that this large volume gave them side effects including bloating and cramping. Other studies showed that a low volume PEG solution with oral bisacodyl fared equally in terms of adequacy of bowel preparation. With the institution of lower volume PEG preparation our offices noted improved patient toleration, satisfaction, and clinical outcomes. However, multiple endoscopists have noticed an increased in intraluminal bubbles and foam with the low volume preparation. This can impair proper visualization of the bowel wall even with an adequate bowel preparation. The current standard of practice includes irrigation, lavage, and suctioning using a simethicone infused saline during the colonoscopy. Its property of reducing surface tension to help dissolve bubbles and clear the field of view is vital during the procedure. Furthermore, it does not dissolve into the blood stream and thereby, is considered rather safe.

This study evaluates whether the addition of oral simethicone with the colonoscopy bowel preparation reduces bubbles and foam during the procedure using a randomized and controlled interventional study.

详细描述

This prospective, multi-center, randomized, controlled, double (patient and endoscopist) blinded study is conducted at the Gastroenterology Consultants outpatient clinics and endoscopy centers in association with the University of Nevada-Reno School of Medicine. After obtaining signed informed consent, outpatients are recruited and randomized into 1 of 2 treatment groups; PEG3350-Bisacodyl with 200 mg liquid simethicone treatment and PEG3350-Bisacodyl treatment with inert placebo (water).

The primary outcome includes reduction of bubbles using the intraluminal bubbles scale. Secondary outcomes include the evaluations of the numbers and types of polyps, numbers and types of masses detected, cecal insertion time, withdrawal time, adverse effects, and the adequacy of bowel prep using the Boston Bowel Prep scale.

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
Triple (Participant, Care Provider, Investigator)

盲法说明

Endoscopist and patient blinded study.

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Eligible for outpatient elective colonoscopy
  • Adult 18-80 years of age able to give consent.
  • English speaking adults.

排除标准

  • History of bowel resection
  • Uncontrolled hypertension
  • Suspected bowel perforation
  • Suspected bowel obstruction
  • Indications for emergent/urgent colonoscopy
  • Non-english speaking individuals

研究组 & 干预措施

Simethicone with PEG-3350 bisacodyl preparation

Active Comparator

Treatment arm:

200 mg Simethicone in 3 mL of liquid formulation mixed with low volume PEG-3350 bisacodyl combination preparation. Bowel preparation taken as per directions including the evening before and the day of the procedure.

干预措施: Simethicone Solution (Drug)

Placebo with PEG-3350 bisacodyl preparation

Placebo Comparator

Placebo arm:

3 mL of water mixed with low volume PEG-3350 bisacodyl combination preparation. Bowel preparation taken as per directions including the evening before and the day of the procedure.

干预措施: Water (Drug)

结局指标

主要结局

Intraluminal Bubbles Scale

时间窗: Data reported during colonoscopy.

I \>90% of the mucosal circumference seen II 90%-75% of the mucosal seen without foam or bubbles not requiring irrigation III 74% to 50% of the mucosa is free of foam or bubbles. Required irrigation IV \<50% of the mucosa seen free of foam or bubbles. Required irrigation

次要结局

  • Number of masses(Data reported during colonoscopy.)
  • Type of masses(Post colonoscopy pathology. Up until pathology data reporting. Estimated up to 2 weeks after colonoscopy.)
  • Cecal insertion time(Data reported during colonoscopy.)
  • Number of polyp(Data reported during colonoscopy.)
  • Withdrawal time(Data reported during colonoscopy.)
  • Type of polyp(Post colonoscopy pathology. Up until pathology data reporting. Estimated up to 2 weeks after colonoscopy.)
  • Adverse effects(From the time of administration of the bowel preparation (day prior to colonoscopy) up until the time of the procedure preparation (pre-colonoscopy preparation). Estimated period of up to 24 hours.)
  • Boston Bowel Preparation Scale(Data reported during colonoscopy.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohit Rishi

Resident physician - Department of Internal Medicine

University of Nevada, Reno

研究点 (2)

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