Comparison of Patient Satisfaction and Efficacy of Different PEG-based Bowel Preparations- an Observational Study in Five Endoscopy Units in Sweden
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,000
- 试验地点
- 5
- 主要终点
- Patient satisfaction with bowel prep
研究概览
简要总结
An multi-center, observational study where we compare the current standard, PEG-based bowel-prep to a (in Sweden) recently approved and introduced low volume (1 litre) PEG-based bowel-prep (Plenvu) in a clinical routine situation.
The investigators will investigate if there are any differences in patient satisfaction and efficacy of the different bowel preparations
详细描述
When performing Colonoscopy it is essential to use a bowel-prep that is highly effective and at the same time tolerable to intake for the patient to ensure that the patients intakes the recommended amount of the bowel-prep.
This in order to be able to detect pathological findings in the mucosa. Currently in n Sweden the standard bowel-prep used in most endoscopy-units is high volume bowel preps (4 litres) in split dose. It can be difficult for the patient to intake the whole dose wish can lead to a sub-optimal bowel-cleansing.
Recently, in Sweden, a new low-volume bowel-prep has been approved and introduced (Plenvu).
This preparation, totally 1 litre of bowel prep given in a split dose is potentially easier for the patient to intake but it is essentially to ensure that the efficacy i at least as good as the current high dose preparation. In this study the investigators will therefore investigate patient satisfaction and efficacy of the different bowel preparations, comparing Plenvu with the current standard bowel-prep regime at the participating endoscopy units.
Five endoscopy units participates in this study (Endoskopi City, Stockholm, Endoskopienheten i Malmö, Endoskopienheten i Linköping, Endoskopienheten i Örebro, Endoskopienheten Ersta sjukhus, Stockholm).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients over 18 admitted for colonoscopy at the participating endoscopy-units.
排除标准
- •Renal failure or other contraindication for using low-dose bowel-preps
- •not speking or reading swedish
- •Need for a translator
结局指标
主要结局
Patient satisfaction with bowel prep
时间窗: Day 1,When arriving to the endoscopy unit, Immediately before the endoscopy
When arriving to the endoscopy unit the patients fills in a questionnaire about their bowel-prep experience concerning; smell, taste, overall experience (five graded scales) of the prep. The higher the number are the more satisfied the patient are with the current experience (smell, taste and overall experience. In the questionnaire they are also asked how much of the prescribed bowel-prep they have digested and how much extra fluid they have been drinking during the preparation process (0-4 litres).
Efficacy of the bowel prep
时间窗: Day 1,Directly after the colonoscopy,
Immediately after the colonoscopy the gastroenterologist who has performed the investigation fills in the Boston Bowel Preparation Scale,a widely used scale describing how clean the bowel is in each of the three segment ant in total. Each segment is graded form 0-3 (3 perfect cleaning) and a sum-score of 0-9 (9 perfect clening) is calculated. The higher the number the better the cleansing are
次要结局
- Differences in the reported frequency of nausea and vomiting during the bowel-preparation process(Day 1,When arriving to the endoscopy unit, Immediately before the endoscopy)
研究者
Perjohan Lindfors
MD, PhD
Karolinska Institutet