Written Endoscopist Recommendation to Improve Adherence to Early Repeat Colonoscopy Within 1 Year in Patients With Inadequate Bowel Preparation.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 465
- 试验地点
- 2
- 主要终点
- Adherence to repeat colonoscopy
研究概览
简要总结
Our study aims to improve adherence to international clinical guidelines of repeating colonoscopy within 1 year, when bowel cleansing has failed. To this end, we have designed an ambispective study in patients with inadequately prepared colonoscopy. An intervention group to which a precise written recommendation on the need to repeat the colonoscopy in less than 1 year is attached, compared with a control group to which no written recommendations are provided.
The sample size calculation is 171 patients per arm. In addition, we will quantify the percentage of pre-malignant and malignant lesions detected at repeat colonoscopy. We will also analyze factors that may be related to the recommendation or non-recommendation of repeat colonoscopy, as well as the association of variables related to adherence to repeat colonoscopy at an interval of less than 1 year.
Through our study, we intend to demonstrate that a written recommendation, easily applicable and generalizable, has a positive impact on adherence to clinical follow-up guidelines in patients in whom bowel cleansing has failed.
详细描述
STUDY HYPOTHESIS
In patients with an inadequately prepared colonoscopy, a written recommendation on the need for repeat colonoscopy in less than 1 year improves adherence.
OBJECTIVES
Main objective
- To evaluate adherence to repeat colonoscopy in less than 1 year, after including an accurate written recommendation, versus not including a written recommendation, in patients with a colonoscopy with inadequate preparation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with a colonoscopy with inadequate bowel preparation for any indication except for colorectal cancer screening
排除标准
- •Patients with no indication for repeat colonoscopy due to clinical criteria
- •Patients with a recommendation to repeat the colonoscopy with a different interval
- •Hospitalized patients
- •Patients with special reprogramming circuit (colorectal cancer screening, hospitalized patients, complex polypectomies, revision of polypectomies)
- •Incomplete examination for other reasons than intestinal cleansing (stenosis, loops, etc...)
- •Patients under 18 years of age
结局指标
主要结局
Adherence to repeat colonoscopy
时间窗: 1 year after index colonoscopy
Adherence to repeat colonoscopy within1 year in patients with inadequate bowel preparation colonoscopy.
次要结局
- Overall adenoma detection rate(At the moment of colonoscopy)
- Complete colonoscopy rate(At the moment of colonoscopy)
- Overall serrated lesion detection rate(At the moment of colonoscopy)
- Overall cancer detection rate(At the moment of colonoscopy)
- Overall advanced adenoma detection rate(At the moment of colonoscopy)
- Boston Bowel Preparation Scale(At the moment of colonoscopy)
研究者
Miguel Angel Pantaleon Sanchez
MD-PhD at Hospital del Mar
Parc de Salut Mar