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临床试验/NCT03119168
NCT03119168已完成4 期

The Effect Of Adding High Dose Simethicone To A Standard Polyethylene Glycol Preparation On Adenoma Detection Rate During Screening Colonoscopy: A Randomized Controlled Pilot Trial

Texas Tech University Health Sciences Center, El Paso1 个研究点 分布在 1 个国家目标入组 268 人开始时间: 2017年3月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
268
试验地点
1
主要终点
Adenoma Detection Rate

研究概览

简要总结

This study is evaluating the effect of adding a high dose of simethicone to the standard polyethylene glycol preparation for screening colonoscopy in the quality of the preparation , adenoma detection rate and withdrawal times.

详细描述

A proper bowel preparation is key to a thorough and safe colonoscopy. Several factors affect the mucosal visualization during colonoscopy, and consequently the quality of such evaluation. Undoubtedly, this can have unfavorable implications like missed lesions. One of the most commonly encountered scenarios is the presence of multiple bubbles that interfere with mucosal visualization. When this occurs, simethicone (an antifoam agent used to reduce bloating when ingested orally) is injected through the colonoscope to eliminate the bubbles and get a clear view of the mucosa. A few studies have used oral simethicone in conjunction with oral preparation agents (PEG, magnesium citrate, sodium phosphate) in an attempt to improve the quality of the preparation. Unfortunately these studies have not used the exact same preparation agent with and without simethicone, making it difficult to draw conclusions on its efficacy. However, it is important to understand that simethicone is not intended to decrease the amount of stool in the colon, and it's purpose is to decrease the amount of bubbles interfering with the visualization of the mucosa provided that there is no stool present . Furthermore, it is unclear if adding simethicone to a standard bowel preparation makes a significant difference in key aspects of screening colonoscopy such as adenoma detection rate or withdrawal times. This prospective randomized controlled, observer blinded study at Texas Tech University Health Sciences Center in El Paso, aims at studying the effect of simethicone on the overall colon preparation as well as on adenoma detection rate and withdrawal times.

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

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

入选标准

  • Patients between the ages of 30-80 scheduled for screening colonoscopy.
  • Male and female patients
  • Ambulatory patients
  • Signed informed consent form

排除标准

  • Previous colonic surgery
  • Patient with mental/physical condition that impairs oral ingestion of preparation
  • Allergy or hypersensitivity to simethicone
  • Patients with limited mobility (bedridden patients)
  • Patients with gastrointestinal obstruction
  • Patients with gastroparesis

研究组 & 干预措施

Simethicone solution + Polyethylenglycol

Experimental

This arm of the study will include the patients assigned to take simethicone solution with their colon preparations ( 4L Polyethyleneglycol)

干预措施: Simethicone Solution (Drug)

Polyethylenglycol

Active Comparator

This arm of the study will include the patients assigned to take a regular bowel preparation (4L Polyethylenglycol)

干预措施: Polyethylenglycol (Other)

结局指标

主要结局

Adenoma Detection Rate

时间窗: 25 minutes

The number of adenomatous polyps removed at colonoscopy

次要结局

  • Withdrawal Times(6-10 minutes)
  • Intraprocedural Use of Simethicone(6-10 minutes)
  • Colon Preparation(25 minutes)

研究者

发起方
Texas Tech University Health Sciences Center, El Paso
申办方类型
Other
责任方
Principal Investigator
主要研究者

Antonio Mendoza-Ladd

Assistant Professor of Medicine

Texas Tech University Health Sciences Center, El Paso

研究点 (1)

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