An Observational, Retrospective and Multicenter Study to Evaluate the Effectiveness and Safety of 1L (PEG)+ Ascorbic Acid Given for Bowel Preparation Prior to Colonoscopy in Iberia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 13,393
- 试验地点
- 12
- 主要终点
- Number of Patients With 'Excellent Plus Good' (Highly Effective) Bowel Cleansing (Colon Ascendens)
研究概览
简要总结
A retrospective study to evaluate the effectiveness and safety of 1L polyethylene glycol (PEG)+ Ascorbic acid given for bowel preparation before colonoscopy.
详细描述
Observational, retrospective, and multicenter study based on the review of the existing medical records of patients followed on an outpatient basis (computerized databases and dissociated data).
The design implies the incorporation of existing anonymized data by the hospital centers without leaving any record of the code assigned to each patient. The design, therefore, avoids the possible risk of the dissemination of the personal data of patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Male and female outpatients aged: ≥18 years undergoing a screening, surveillance, or diagnostic colonoscopy between June 1, 2019, to September 1, 2021
- •Who have used NER1006 in the preparation of the colonoscopy either in split doses or same day.
排除标准
- •History of colorectal cancer o colectomy before the first colonoscopy
- •Impossibility to obtain the required mandatory data
结局指标
主要结局
Number of Patients With 'Excellent Plus Good' (Highly Effective) Bowel Cleansing (Colon Ascendens)
时间窗: Up to 2 days (from day of first dosing to day of colonoscopy)
Proportion of patients with a high-quality cleaning in the right colon defined as a BBPS score = 3.
Number of patients With Successful Bowel Cleansing (Overall Colon)
时间窗: Up to 2 days (from day of first dosing to day of colonoscopy)
The proportion of patients with adequate total colon cleansing is defined as a Boston Bowel preparation scale (BBPS) score ≥ 2 in all segments (BBPS\> 6).
次要结局
- Withdrawal time(Up to 2 days (from day of first dosing to day of colonoscopy))
- Tolerability of the preparation, if available(Up to 2 days (from day of first dosing to day of colonoscopy))
- Polyps Detection Rate in the total colon and in the right colon(Up to 2 days (from day of first dosing to day of colonoscopy))
- Adherence to the preparation, if available.(Up to 2 days (from day of first dosing to day of colonoscopy))
- Safety of the preparation(Up to 2 days (from day of first dosing to day of colonoscopy))
- Treatment satisfaction, if available(Up to 2 days (from day of first dosing to day of colonoscopy))
- Sub-analyzes will be conducted in different patient populations(Up to 2 days (from day of first dosing to day of colonoscopy))
- Sub-analyzes of the primary and secondary outcomes(Up to 2 days (from day of first dosing to day of colonoscopy))
- Adenoma Detection Rate in the total colon and in the right colon(Up to 2 days (from day of first dosing to day of colonoscopy))
- Cecal intubation rate(Up to 2 days (from day of first dosing to day of colonoscopy))
- Quality of the preparation (BBPS> 2 in all colon segments) depending on the dietary guideline(Up to 2 days (from day of first dosing to day of colonoscopy))
- Cecal intubation time(Up to 2 days (from day of first dosing to day of colonoscopy))