Investigation of the Effect of Different Same-day Colonoscopic Bowel Preparation Procedures on Patient Compliance, Tolerability, and Bowel Cleansing: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 128
- 主要终点
- Compliance and Tolerance to the Bowel Preparation Protocol
研究概览
简要总结
The aim of this study was to investigate the effect of different bowel preparation protocols applied on the same day on patients' compliance, tolerance and bowel cleansing before colonoscopy.
Hypotheses of the Study : Same-day administration of bowel preparation before colonoscopy; H1.1: There is a significant difference between the bowel preparation protocol with polyethylene glycol (Protocol I) and the protocol with sodium phosphate (Protocol II) in bowel preparation score scores H1.2: There is a significant difference between the compliance levels of the patients who underwent a bowel preparation protocol containing polyethylene glycol (Protocol I) and a protocol containing sodium phosphate (Protocol II) H1.3: There is a significant difference between the tolerance of the patients who underwent a bowel preparation protocol containing polyethylene glycol (Protocol I) and a protocol containing sodium phosphate (Protocol II)
In patients in Protocol I and II groups, data will be collected one day before the procedure with the Descriptive Characteristics Form and the procedure will be explained face to face. After the procedure, bowel preparation score during colonoscopy and compliance and tolerance to the bowel preparation protocol will be evaluated from the patients in both groups.
详细描述
The aim of this study was to investigate the effect of different bowel preparation protocols applied on the same day on patients' compliance, tolerance and bowel cleansing before colonoscopy.
This study will be conducted as a single centre prospective randomised controlled trial in accordance with the principles of the Declaration of Helsinki. The study will be conducted in a private clinic in Famagusta region in patients undergoing colonoscopy.
Patients undergoing colonoscopy will be given written material about bowel preparation the day before the procedure and the protocol will be explained verbally and in writing. The bowel preparation protocol is described below.
Protocol I 06.30 Breakfast 09.00 hours: Phospho-Soda 45 ml 10.00: Phospho-Soda 45 ml At least 3 litres of liguid fluid intake until 14.00 14.30- 15.00: Colonoscopy Protocol II 06.30 Breakfast 09.00 :Polyethylene Glycol (PEG) will be diluted with 4 litres of water and one glass (200ml) will be drunk every 10 minutes until it is finished (It will be finished in about 4 hours) Colonoscopy after 2 hours Inclusion criteria
- Over 18 years of age
- Drinking at least 75 per cent of the solution
- Have the ability to read and understand research instructions
- Patients who agreed to participate in the study Sampling exclusion criteria
- Patients with active lower intestinal bleeding Patients diagnosed with CHF, liver failure, end-stage acute renal failure
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
The statistician will not know which group the intervention is for. Data entry will be made as A and B.
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
- •Drinking at least 75 per cent of the solution
- •Have the ability to read and understand research instructions
- •Patients who agreed to participate in the study
排除标准
- •Patients with active lower intestinal bleeding
- •Liver failure,
- •Patients with end-stage acute renal failure
结局指标
主要结局
Compliance and Tolerance to the Bowel Preparation Protocol
时间窗: The patients were interviewed 30-60 dk minutes after the procedure was completed.
The Bowel Preparation Protocol Compliance and Tolerance Assessment Form will assess this primary outcome. This form assesses tolerance to the bowel preparation protocol; abdominal pain, nausea, vomiting, Abdominal distension -gas,thirst , headache, weakness and fatigue and intolerance to the solution. The rate of patients experiencing variables including Compliance and Tolerance to the Bowel Preparation Protocol will be calculated.
次要结局
- Bowel cleansing quality level(BBPS will be assessed by the surgeon during colonoscopy.)
研究者
Gülten Sucu Dağ
Assoc Prof
Eastern Mediterranean University