A Repeated Instruction by Telephone on the Day Before Colonoscopy Improves the Quality of Bowel Preparation and Colonoscopy Procedure : a Prospective Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 605
- 试验地点
- 1
- 主要终点
- Adequate bowel preparation quality at the time of colonoscopy defined by Ottawa score<6
研究概览
简要总结
Cell phone retell the instruction of bowel preparation on the day before colonoscopy would help patient to prepare for colonoscopy and improve the quality of the bowel preparation.
详细描述
Colonoscopy is the gold standard in the diagnosis of colorectal disease. The success of colonoscopy depends on high-quality bowel preparation by patients. Inadequate bowel cleansing reduces the speed, the cecal intubation rate, and the number of polyps detected. It also increases costs, mostly due to repeated procedures. The quality of bowel cleansing has remained suboptimal even though numerous different products and regimens have been tested and compared in no fewer than six meta-analyses. Therefore, a completely different approach to improve precolonoscopy bowel cleansing is welcome.
There are many factors effect the bowel preparation such as age, cirrhosis diabetes, drug compliance, cerebral infarction, dementia, history of major surgery. 20% of patients with poor bowel preparation were due to bad compliance. Studies found that addressing patient perceptions with an inexpensive and simple booklet based on the Health Belief Model improved preparation quality. We assume that doctor retelling the instruction of bowel preparation by cell phone on the day before colonoscopy would help patient to prepare for colonoscopy and improve the quality of the bowel preparation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients undergoing colonoscopy
排除标准
- •disturbance of water and electrolyte
- •history of colorectal surgery
- •severe colonic stricture or obstructing tumor
- •known or suspected bowel obstruction or perforation
- •toxic colitis or megacolon
- •dysphagia
- •compromised swallowing reflex or mental status
- •significant gastroparesis or gastric outlet obstruction or ileus
- •severe chronic renal failure (creatinine clearance <30 mL/minute)
- •severe congestive heart failure (New York Heart Association class III or IV)
- •uncontrolled hypertension (average systolic blood pressure >170 mm Hg, average diastolic blood pressure >100 mm Hg)
- •pregnant or lactating women
- •patients who cannot give informed consent
结局指标
主要结局
Adequate bowel preparation quality at the time of colonoscopy defined by Ottawa score<6
时间窗: up to 3 months
Ottawa score：A)cleanliness of each part of the colon: 0=excellent 1=good 2=fair 3=poor 4=inadequate B)fluid in whole colon: small=0 moderate=1 large=2 The bowel preparation was considered inadequate if (1) inadequate visualization on colonoscopy defined by Ottawa score≥6; (2) the colonoscopy was cancelled because of poor bowel preparation or personal reasons; (3) incomplete colonoscopy.
次要结局
- Cecum intubation time(up to 3 months)
- Withdrawal time(up to 3 months)
- Polyp detection rate(up to 3 months)
- Compliance rate to instruction(up to 3 months)
- Willingness undergo a repeated bowel preparation(up to 3 months)
研究者
Yanglin Pan
Associated professor
Air Force Military Medical University, China