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临床试验/NCT01788709
NCT01788709已完成4 期

PEG-Electrolyte Solution (FORTRANS®) With Mentholyptus Drops (Halls®) Versus Reduced Volume Ascorbic Acid Supplemented PEG-Electrolyte (MoviPrep®) in Colonoscopy Preparation: A Randomised Controlled Study

American University of Beirut Medical Center1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2013年1月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
入组人数
200
试验地点
1
主要终点
Bowel preparation quality

研究概览

简要总结

The colonoscopy accuracy and safety depend on the quality of colon cleansing. An inadequately prepped bowel will increase the risk of missing a lesion, prolong procedure, increase patient discomfort, and eventually increase complication rate. Therefore an excellent colon cleansing is of extreme importance to the endoscopist and the patient.

Split Fortrans® prep with sugar-free mentholyptus drops (Halls®) has a better palatability and tolerability than the reduced volume ascorbic acid-supplemented PEG-electrolyte (MoviPrep®) in bowel cleansing for colonoscopy.

详细描述

Abstract:

Colorectal cancer is amongst the leading cancers worldwide. Treatment is greatly dependent on the stage of illness, with more favorable outcomes associated with early cancers. For this reason, screening colonoscopies have been increasing, as are efforts to improve the quality of bowel preparations. The colonoscopy accuracy and safety depend on the quality of colon cleansing. An inadequately prepped bowel will increase the risk of missing a lesion, prolong procedure, increase patient discomfort, and eventually increase complication rate. Hence, an Ideal bowel cleansing solution would quickly and reliably clean the colon while having a good tolerability and palatability to the patient. Current colonoscopy preparation regimens require the use of large volume of iso-osmotic PEG-electrolyte solution for adequate cleansing and are often poorly tolerated by patients. We have shown previously that mentholyptus drops significantly improved the palatability of PEG-electrolyte (Fortrans®) solution and the quality of preparation (1). We aim at this study to compare the efficacy of the above-mentioned prep technique and the reduced volume ascorbic acid-supplemented PEG-electrolyte (MoviPrep®). This is a randomized controlled trial that 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. 100 Patients will be asked to have candy (Halls®) during the whole 2 hours period while drinking the PEG solution (Fortrans®). Another 100 patients will be asked to take reduced volume ascorbic acid-supplemented PEG-electrolyte (MoviPrep®). All patients will then be interviewed by the research coordinator to evaluate 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. Based on the results of a pilot study, our sample size calculation showed that 100 patients per arm will be enough to attain significance. As for the statistical analysis, SPSS version 20.0 will be used for data entry and analysis.

I- Aim:

To compare the efficacy of split PEG-electrolyte (Fortrans®) with mentholyptus (Halls®) drops and the reduced volume ascorbic acid-supplemented PEG-electrolyte (MoviPrep®) in improving the palatability of solution used in bowel cleansing for colonoscopy.

II- Background:

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
Single (Outcomes Assessor)

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
否

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 (New York Heart Association [NYHA] class III or IV)
  • •Dehydration
  • •Severe acute inflammatory disease
  • •Compromised swallowing reflex or mental status
  • •Uncontrolled hypertension (SBP ≥170 mm Hg, DBP ≥100 mm Hg)
  • •Toxic colitis or megacolon
  • •Patients with IBD
  • •Status post partial colon resection
  • •Severe constipation and laxative dependent

研究组 & 干预措施

A

Active Comparator

Fortrans (split dose) + Mentholyptus drops

干预措施: preparation cleaning solution (Other)

B

Active Comparator

MoviPrep (split dose)

干预措施: preparation cleaning solution (Other)

结局指标

主要结局

Bowel preparation quality

时间窗: 6 months

Superiority of Fortrans + Halls to MoviPrep in cleansing the bowels

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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