Multidisciplinary Approach Versus Conventional Approach in Colonic Preparation of Hospitalized Patients. A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 162
- 试验地点
- 1
- 主要终点
- percentage of patients with adequate bowel preparation
研究概览
简要总结
Colonoscopy is the gold standard diagnostic procedure for colonic disease. Excellent bowel cleansing is critical for this procedure. However, an inadequate bowel cleansing is a common problem that occurs up to 20% of procedures. This fact has a deep clinical and economical impact. In fact, inadequate bowel preparation is associated to misdiagnosis in 30% of lesions. Moreover several clinical conditions such as cirrhosis, antidepressant drugs, and hospitalized patients are predictive factors of inadequate colonic preparations. These circumstances have promoted multiple clinical trials, however there is no consensus about the optimal strategy for colonic cleansing. Education in colonic preparation has obtained conflicting results. Polyethylene glycol (PEG) and sodium phosphate solutions have been the commonest preparations used with a similar efficacy. However, the large volume to ingest (4 litters) makes PEG compliance difficult. Likewise, sodium phosphate also contains high levels in sodium and phosphate which contraindicate its use in elderly patients and / or with comorbidity. The use of adjuvants such as olive oil and bisacodyl allows reducing the volume of polyethylene glycol thereby improving the tolerance and right colon preparation.
The aim of this study is to compare the efficacy of a multidisciplinary approach (education, fiber free diet, polyethylene glycol (PEG) 2L, and adjuvant bisacodyl + olive oil) vs. a conventional approach (fiber free diet+ PEG 4L in split doses ) in cleaning the colon of hospitalized patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
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
- •Hospitalized patients who undergo a non urgent colonoscopy
- •Patients who give informed consent to participate in the study
- •Patients older than 18 years
- •Patients who undergo total colonoscopy
排除标准
- •Non compliance with the 48 hours diet prescribed
- •The endoscopy planned is a rectosigmoidoscopy
- •Previous colonic surgery
- •Mental/cognitive impairment preventing the study assessments
- •Severe renal failure
- •Electrolytic disbalance(hyponatremia, hypokaliemia, Hyperphosphatemia, hypocalcemia and hypomagnesemia)
- •Intestinal obstruction, perforation or toxic megacolon
- •Pregnant or nursing women
- •Allergy/intolerance to PEG, bisacodyl or adjuvants
- •No informed consent
研究组 & 干预措施
Conventional approach
The conventional approach will include:
Education Fiber free diet Polyethylene glycol (PEG): 2 L the night before the procedure, 2 L 3 hours before the procedure
干预措施: Polyethylene glycol (PEG) (Drug)
Multidisciplinary approach
The multidisciplinary approach will include:
Education Fiber free diet Bisacodyl: 10 mg 2 days before the procedure, 20 mg the day before the procedure and 10 mg 3 hours before the procedure Adjuvants: Olive Oil:60 mL/Apple Juice: 200 mL PEG: 1 L the night before the procedure and 1 L 3 hours before the procedure
干预措施: Education (Behavioral)
Multidisciplinary approach
The multidisciplinary approach will include:
Education Fiber free diet Bisacodyl: 10 mg 2 days before the procedure, 20 mg the day before the procedure and 10 mg 3 hours before the procedure Adjuvants: Olive Oil:60 mL/Apple Juice: 200 mL PEG: 1 L the night before the procedure and 1 L 3 hours before the procedure
干预措施: Fiber free diet (Other)
Multidisciplinary approach
The multidisciplinary approach will include:
Education Fiber free diet Bisacodyl: 10 mg 2 days before the procedure, 20 mg the day before the procedure and 10 mg 3 hours before the procedure Adjuvants: Olive Oil:60 mL/Apple Juice: 200 mL PEG: 1 L the night before the procedure and 1 L 3 hours before the procedure
干预措施: Adjuvants (Dietary Supplement)
Multidisciplinary approach
The multidisciplinary approach will include:
Education Fiber free diet Bisacodyl: 10 mg 2 days before the procedure, 20 mg the day before the procedure and 10 mg 3 hours before the procedure Adjuvants: Olive Oil:60 mL/Apple Juice: 200 mL PEG: 1 L the night before the procedure and 1 L 3 hours before the procedure
干预措施: Polyethylene glycol (PEG) (Drug)
Multidisciplinary approach
The multidisciplinary approach will include:
Education Fiber free diet Bisacodyl: 10 mg 2 days before the procedure, 20 mg the day before the procedure and 10 mg 3 hours before the procedure Adjuvants: Olive Oil:60 mL/Apple Juice: 200 mL PEG: 1 L the night before the procedure and 1 L 3 hours before the procedure
干预措施: Bisacodyl (Drug)
Conventional approach
The conventional approach will include:
Education Fiber free diet Polyethylene glycol (PEG): 2 L the night before the procedure, 2 L 3 hours before the procedure
干预措施: Education (Behavioral)
Conventional approach
The conventional approach will include:
Education Fiber free diet Polyethylene glycol (PEG): 2 L the night before the procedure, 2 L 3 hours before the procedure
干预措施: Fiber free diet (Other)
结局指标
主要结局
percentage of patients with adequate bowel preparation
时间窗: at the time of performing the colonoscopy
Adequate bowel preparation is defined as a preparation which allows exploring the whole colonic mucose and detecting flat lesions (Rating as good or excellent in the Boston Bowel preparation scale)
次要结局
- Percentage of patients with adequate bowel preparation by bowel segments(At the time of performing the colonoscopy)
- Tolerance to the colonoscopy(from colonoscopy up to 24 hours after colonoscopy)
- Percentage of complete/incomplete colonoscopies and reprogramming(After the colonoscopy)
- Complications during and after the procedure(up to 24 hours after colonoscopy)
- Doses of sedation needed during the colonoscopy(During the colonoscopy process)
- Tolerance to the preparation(up to 48 hours)
- Endoscopic findings(during the colonoscopy)
研究者
Felix Junquera
Consultant Physician - Gastroenterology
Corporacion Parc Tauli