Providing Specific Verbal Instructions Improves Bowel Preparation of Inpatients Undergoing Colonoscopy: a Multi-center Single Blinded Randomized Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Increase in the number of examinations with adequate bowel preparation
研究概览
简要总结
To study the impact of providing specific verbal instructions in inpatients (and/or their relatives) undergoing colonoscopy on the quality of bowel preparation.
详细描述
Introduction Adequate bowel preparation constitutes one of the most important endoscopy quality indicators: it is related with increased detection of pathologic findings, reduces the need for repeated colonoscopies and leads to burden lightening for both patients and endoscopy departments. Different factors have been related to inadequate preparation. Among them, inpatient status has been identified as a major independent risk factor.
It has been shown that providing outpatients with simple, but specific instructions regarding the importance and mode of adequate preparation - either through a leaflet, a sms or on the web - improves significantly the level of bowel cleanliness. However, data regarding the success of such an intervention in inpatients lack.
Aim To study the impact of providing specific verbal instructions in inpatients (and/or their relatives) undergoing colonoscopy on the quality of bowel preparation.
Patients - Methods Study Design This is a prospective, randomized, single-blinded study. Four Greek academic endoscopy departments will competitively enroll patients during a period of 6 months.
Randomization A central randomization list will be computer-assisted, created and sent to one collaborator of each center. Endoscopists will be blinded to participant's group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Investigator)
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
- •assignment of informed consent
排除标准
- •inability to provide informed consent
- •history of colectomy
- •indication for rectosigmoidoscopy
- •lack of knowledge of the Greek language.
结局指标
主要结局
Increase in the number of examinations with adequate bowel preparation
时间窗: At colonoscopy completion
Bowel preparation will be considered adequate if overall BBPS≥6 and all segments achieving BBPS≥2.
次要结局
- Overall BBPS score change(At colonoscopy completion)
- Segmental BBPS score changes(At colonoscopy completion)
- Total examination time, cecal intubation time and time needed to washout during the colonoscopy(At colonoscopy completion)
- Cecal intubation rate(At cecum intubation)
- Percentage of patients who received the whole amount of liquid preparation(Before colonoscopy start)
- Polyp and adenoma detection rate (overall and per segment)(Up to 4 weeks after patient's enrollment)
- Side effects related either to the preparation or the examination(Before colonoscopy start)
- Identification of potential additional risk factors for inadequate preparation(After colonoscopy completion)
- Patient satisfaction from the bowel preparation using the visual analogue scale.(After colonoscopy completion)
研究者
ATHANASIOS SIOULAS
Dr
Attikon Hospital