Improvement of Tolerability for Bowel Preparation for Colonoscopy in Diabetic Patients. A Randomized Controlled Trial of Two Bowel Preparation Protocols Including 4 Liters PEG vs. 2 Liters PEG Plus Ascorbic Acid. iDIMEPREP Study.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 158
- 试验地点
- 2
- 主要终点
- Tolerability of the bowel preparation (analogue visual scale)
研究概览
简要总结
This trial will compare the tolerance to 2 different methods for colon cleansing before colonoscopy in diabetic patients.
详细描述
Consecutive diabetic patients undergoing an ambulatory colonoscopy at the participating sites will be randomized to 2 different methods of colon cleansing before the procedure.
Both will be based on the oral ingestion of a fluid solution (half of it on the evening before the procedure is planned and the rest on the morning of the same day), and the main difference between them will be the volume of fluid that will be ingested in each case.
Analogic visual scales and standardized questionnaires on various aspects that may influence the degree of satisfaction about the preparation will be answered by the participants and collected before the colonoscopy. The endoscopist, blinded to the preparation method, will grade the adequacy of the preparation. Adverse events will be recorded up to 1 month after the procedure
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Care Provider)
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
- •Patients scheduled for a diagnostic, screening or follow-up outpatient colonoscopy
- •Diabetes mellitus (being treated with insulin or any oral agent).
排除标准
- •Unwillingness to participate.
- •Hospital admission at the time of colonoscopy.
- •Inability to follow instructions
- •Active inflammatory bowel disease
- •Previous colectomy.
- •Incomplete colonoscopies due to technical reasons or contraindication for the procedure as evaluated by the endoscopist
研究组 & 干预措施
PEG-ascorbate 2L
Subjects will take 2 liters of a polyethylene glycol 3500 (sodium sulphate, sodium chloride, postassium chloride), ascorbic acid and sodium ascorbate solution.
干预措施: PEG-ascorbate 2L (Drug)
PEG 4L
Subjects will take 4 liters of a polyethylene glycol 4000 (sodium sulphate, sodium chloride, postassium chloride and sodium bicarbonate) solution.
干预措施: PEG 4L (Drug)
结局指标
主要结局
Tolerability of the bowel preparation (analogue visual scale)
时间窗: 6 hours after finishing bowel preparation
Each participant will rate his/her experience in an analogue visual scale.
次要结局
- Adverse events(30 days after the colonoscopy)
- Abdominal pain, nausea and bloating (analogue visual scale)(6 hours after finishing bowel preparation)
- Efficacy of the bowel preparation (Boston Bowel Preparation Scale (BBPS)(10 minutes after the colonoscopy)
- Acceptability of the preparation (interference with work, leisure activities or sleep questionnaire)(6 hours after finishing bowel preparation)
- Adherence to the planned bowel cleansing method (questionnaire)(6 hours after finishing bowel preparation)
- Ease of consumption and taste of the laxative (analogue visual scale)(6 hours after finishing bowel preparation)
研究者
Marco Antonio Alvarez Gonzalez
MD
Parc de Salut Mar