Digitising colonoscopy care pathways and enhancing bowel preparation quality with patient reported measures (DIGICLEAN).
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https://www.omicsdi.org/dataset/ecrin-mdr-crc/2733492
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Interventions: Participants in the interventional arm of the study will receive their bowel preparation instructions delivered via scheduled SMS, web-based smartphone application, email, and videos. All enrolled participants must possess a smartphone device. The interventional arm will occur in parallel design with the control arm. Depending on whether participants have a history of constipation, bloating, or diverticular disease as assessed by the faecal occult blood test (FOBT) nurse or the gastroenterologist at the initial phone call, participants will be stratified into one of two groups depending on their indicated bowel preparation regimens.
Participants will be either given Standard Bowel Preparation instructions with PLENVU [macrogol 3350, sodium ascorbate, sodium sulfate anhydrous, ascorbic acid, sodium chloride, potassium chloride; polyethylene glycol containing ascorbic acid (PEG-ASC)], or Enhanced Bowel Preparation [PLENVU plus daily Movicol (sodium chloride, potassium chloride, bicarbonate, macrogol 3350) and Senokot (sennoside)]. Additional aperients, such as Movicol and Senokot, will be encouraged in the interventional arm through dynamic multimedia instructions if indicated. Participants will be asked to take PLENVU over a two-day split dosing schedule with the first 500 mL dose of PLENVU (including additional 500 mL of clear fluid) taken in the evening before the clinical procedure (at 6 pm) and the second 500 mL dose (including additional 500 mL of clear fluid) in the early morning of the day of the clinical procedure (at 5 am for morning procedure or 8 am for afternoon procedures). Participants in the Enhanced Bowel Preparation group will also take 1 sachet of Movicol and 2 Senokot tablets daily at 0800 in the week leading up to the colonoscopy.
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Primary outcome(s): Comparison of the adenoma detection rate based on histopathology assessment of biopsy samples collected at the time of colonoscopy in patients randomised to receive dynamic multimedia bowel preparation instructions versus those that receive verbal and/or written bowel preparation instructions.[At the time of colonoscopy assessment.];Compare the patient reported measures using the validated colonoscopy-specific Newcastle ENDOPREM Questionnaire on the day after colonoscopy between patients randomised to receive dynamic multimedia bowel preparation instructions versus those that receive standard verbal and/or written bowel preparation instructions.[One day after colonoscopy assessment.]
Study Design: Purpose: Diagnosis; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy
干预措施:本研究试验组受试者将通过定时短信、基于网页的智能手机应用程序、电子邮件及视频渠道获取肠道准备指导。所有入组受试者均需配备智能手机设备。试验组与对照组采用平行设计方案。根据受试者在首次电话随访时由粪便隐血试验(faecal occult blood test, FOBT)护士或胃肠病医师评估的便秘、腹胀或憩室病病史,将受试者按照其适用的肠道准备方案分为两组。
受试者将分别接受标准肠道准备指导(使用PLENVU[聚乙二醇3350、抗坏血酸钠、无水硫酸钠、抗坏血酸、氯化钠、氯化钾;含抗坏血酸的聚乙二醇(PEG-ASC)]),或强化肠道准备方案(PLENVU联合每日服用聚乙二醇4000散(Movicol,成分为氯化钠、氯化钾、碳酸氢钠、聚乙二醇3350)及番泻苷片(Senokot,成分为番泻苷))。若存在临床指征,试验组将通过动态多媒体指导鼓励受试者额外使用缓泻剂,如Movicol及Senokot。受试者需分两日服用PLENVU:首剂500mL PLENVU(需配合额外500mL清亮液体)于临床操作前一日傍晚(18:00)服用,第二剂500mL PLENVU(同样配合额外500mL清亮液体)于临床操作当日清晨(上午操作则于5:00,下午操作则于8:00)服用。强化肠道准备组受试者还需在结肠镜检查前一周内,每日08:00服用1袋Movicol及2片Senokot。
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主要结局指标:1. 对比随机接受动态多媒体肠道准备指导的受试者与接受口头及/或书面肠道准备指导的受试者,其结肠镜检查时采集的活检样本经组织病理学评估后的腺瘤检出率[结肠镜检查评估阶段];2. 对比两组受试者在结肠镜检查次日,使用经过验证的结肠镜特异性纽卡斯尔ENDOPREM问卷报告的患者自评指标[结肠镜检查评估后1日]。
研究设计:研究目的:诊断性研究;分配方案:随机对照试验;设盲:采用设盲法;分组方式:平行分组;终点类型:有效性
创建时间:
2023-03-15



