1L-PEG-Asc Solution for Bowel Preparation in an "Open Access" Colonoscopy Booking System: Evaluation of Adverse Events
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5,981
- 试验地点
- 1
- 主要终点
- Safety of BP was assessed by reviewing the number of admissions to the Emergency Department of our Hospitals and the main presentation symptom/diagnosis in the 7 days following the colonoscopy.
研究概览
简要总结
Several factors are considered as the key indicators of quality colonoscopy, including endoscopist experience, withdrawal time, and quality of bowel preparation (BP). A number of laxatives are currently used as BP, and these are mainly based on PEG agents that differ for the volume and the addition of adjuvants. Several trials have demonstrated the efficacy and safety of low volume 2L-PEG based regimens compared with high volume PEG regimens and non-PEG agents. However, for low-volume 1L-PEG plus ascorbate (1L-PEG-Asc) only the data from registration trials are available, and none of these have been performed in an "open access" colonoscopy booking system. The aim of our study was to evaluate the safety and tolerability of 1L-PEG-Asc compared to 2L-PEG plus ascorbate (2L-PEG-Asc) in an "open access" booking system.
详细描述
All patients who underwent "open access" colonoscopy in our Unit from January 2019 to September 2020 were evaluated as part of a quality improvement project. Only patients taking 2L-PEG-Asc and 1L-PEG-Asc were enrolled in this study. Safety of BP was assessed by reviewing the number of admissions to the Emergency Department of our Hospitals and the main presentation symptom/diagnosis in the 7 days following the colonoscopy. Tolerability was evaluated as the compliance to full BP intake
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 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
- •From January 2019 to September 2020, data from all consecutive adult (aged ≥ 18 years old) patients who underwent "open access" colonoscopy performed in our Digestive Endoscopy Unit (which is based in the Hospitals of Carpi, Castelfranco Emilia, Mirandola, Pavullo and Vignola) were collected using an electronic reporting system
排除标准
- •Pregnant of breastfeeding patients
结局指标
主要结局
Safety of BP was assessed by reviewing the number of admissions to the Emergency Department of our Hospitals and the main presentation symptom/diagnosis in the 7 days following the colonoscopy.
时间窗: from January 2019 to September 2020
The safety of BPs was assessed by reviewing the clinical and laboratory data of patients who attended the Emergency Department (ED) of the five Hospitals of our Digestive Endoscopy Unit in the 7 days following the colonoscopy. This was feasible since the electronic reporting system is the same across our five Hospitals.
次要结局
- Tolerability was evaluated as the compliance to full BP intake.(from January 2019 to September 2020)
研究者
Dr. Mauro Manno
Director
Azienda USL Modena