Randomized Clinical Trial on the Efficacy of an Adapted Bowel Preparation for Diabetic Patients Undergoing a Colonoscopy. DIMEPREP Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 4
- 主要终点
- Efficacy of the bowel preparation
研究概览
简要总结
This trial will compare the efficacy of to 2 different sets of dietary recommendations to be followed before colon cleansing for colonoscopy in diabetic patients.
详细描述
Consecutive diabetic patients undergoing an ambulatory colonoscopy at the participating sites will be randomized to follow one of two different sets of dietary recommendations. The experimental group will be asked to start a low-residue diet 4 days before the procedure, during which the therapy for diabetes will be adjusted. The control group will be asked to follow a low-residue diet for 3 days followed by a liquid diet during the day before the procedure, and no adjustments will be made to their usual treatment.
Colon cleansing will be undertaken with polyethylene glycol (4 liters in the usual split administration scheme) in both groups.
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
结局指标
主要结局
Efficacy of the bowel preparation
时间窗: 1 hour after the colonoscopy
Rating of the Boston Bowel Preparation Scale (BBPS) by the endoscopist
次要结局
- Acceptability of the preparation (interference with work, leisure activities or sleep(6 hours after finishing bowel preparation)
- Predictors of inadequate bowel preparation(Baseline)
- Polyp and adenoma detection(1 hour after the colonoscopy)
- Adverse events(30 days after the colonoscopy)
- Cecal intubation(1 hour after the colonoscopy)
- Abdominal pain, nausea, hunger and bloating(6 hours after finishing bowel preparation)
- Adherence to the planned bowel cleansing method (questionnaire)(6 hours after finishing bowel preparation)
- Symptomatic hypoglycemia(6 hours after finishing bowel preparation)
研究者
Marco Antonio Alvarez Gonzalez
MD
Parc de Salut Mar