Randomized Clinical Trial to Evaluate the Colon Cleansing Quality of Polyethylene Glycol Compared With Polyethylene Glycol Plus Ascorbic Acid in Patients With Past Poor Colonic Preparation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 472
- 试验地点
- 1
- 主要终点
- Colon cleansing
研究概览
简要总结
The purpose of the study is to assess whether a low volume polyethylene glycol (PEG) plus ascorbic acid based bowel preparation for colonoscopy is not inferior to a large volume polyethylene glycol preparation in subjects with past history of poor bowel preparation
详细描述
Two key quality indicators for colonoscopy are the cecal intubation rate and the percentage of neoplastic lesions detected. Both factors are associated with adequate bowel cleansing. Poor cleansing ranged from 5% to 30% across studies, negatively affecting the efficiency of colonoscopy.
The most important factor associated with poor colonic preparation is the past history of poor bowel preparation. However, there are no recommendations on the proper type of preparation in those patients. In two non-randomized studies inadequate cleansing in the second colonoscopy ranged from 9.8% to 23%. Randomized studies comparing high volume (3-4 liters) with low volume (2 liters) PEG preparations, which are better tolerated by patients, are therefore needed before making any recommendations in this regard.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age> 18 years
- •Outpatients with a history of past poor bowel prep, defined according to the Boston scale as a score less than
- •Signed informed consent
排除标准
- •paralytic ileus, intestinal obstruction, megacolon, poorly controlled hypertension (systolic pressure> 180, dyastolic pressure> 100), congestive heart failure, acute liver failure, end stage renal disease (dialysis or pre-dialysis), New York Heart Association class III-IV, pregnancy, diagnosis of phenylketonuria, diagnosis of glucose-6-phosphate dehydrogenase deficiency, dementia. History of poor preparation in the previous colonoscopy, colon resection, less than 75% intake of the bowel preparation in the index colonoscopy, refusal to participate in the study, patients in whom a new colonoscopy is not indicated despite a poor bowel preparation(i.e. ileal Crohn disease with poor large bowel preparation), lack of compliance with the bowel preparation schedule.
研究组 & 干预措施
High volume
- Two 5 mg bisacodyl tablets It is a stimulant laxative with local action.
- Polyethylene glycol 4000: 16 envelopes (70 g of powder each). It includes electrolytes and sodium sulfate.
干预措施: Polyethylene glycol 4000 (Drug)
Low volume
- Two 5 mg bisacodyl tablets, taken in the same way as for the high volume group.
- Macrogol 3350 plus ascorbic acid: 4 envelopes, 2 containing 112 g polyethylene glycol and electrolytes and 2 with 2 g of ascorbic acid.
干预措施: Macrogol 3350 plus ascorbic acid (Drug)
结局指标
主要结局
Colon cleansing
时间窗: 30 days
Colon cleansing will be assessed just after colonoscopy by the endoscopist in charge of performing the examination and afterwards images were reviewed by a the staff of endoscopists for validation (30 days). For assessing colon cleansing a validated scale (Boston scale) will be used.
次要结局
- Detection of colorectal neoplasia(14 months)
- Tolerance of bowel preparation(Tolerance will be assessed just before colonoscopy by a research assistant)
研究者
Alberto Domínguez Rodríguez
MD,PhD
Fundación Canaria Rafael Clavijo para la Investigación Biomédica