Comparison of Three Different Rescue Bowel Preparation Regimens in Patients With Previous Bowel Cleansing Failure at Colonoscopy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Adequate bowel preparation at repeat colonoscopy
研究概览
简要总结
The goal of this clinical trial is to learn which rescue bowel preparation works best for adults who need a repeat colonoscopy after a previous bowel preparation did not clean the bowel well enough. The study will also look at how satisfied participants are with each preparation. The main questions it aims to answer are:
- Which bowel preparation helps more participants achieve adequate bowel cleansing before repeat colonoscopy?
- Which bowel preparation leads to better cleansing in different parts of the colon?
- Which bowel preparation is better tolerated by participants?
Researchers will compare 3 rescue bowel preparation regimens to see which one works best for repeat colonoscopy after a previous cleansing failure.
Participants will:
- be randomly assigned to 1 of 3 bowel preparation regimens
- take one of the following regimens before repeat colonoscopy:
- 4 liters of polyethylene glycol (PEG) plus 12 milligrams of bisacodyl
- 1 liter of PEG plus ascorbic acid plus 10 milligrams of bisacodyl
- 2 liters of PEG plus extra PEG taken over the 3 days before colonoscopy
- undergo repeat colonoscopy
- rate their satisfaction with the bowel preparation
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 (Outcomes Assessor)
盲法说明
This trial is open-label for participants, care providers, and investigators. However, the colonoscopist assessing bowel cleansing at repeat colonoscopy was not aware of the assigned bowel preparation regimen.
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
- •Adults aged 18 years or older
- •Prior inadequate bowel preparation (adequately performed) requiring repeat colonoscopy
- •Scheduled to undergo repeat outpatient colonoscopy
- •Ability to provide informed consent
排除标准
- •Age younger than 18 years
- •Inability to provide informed consent
- •Contraindication to any study bowel preparation regimen or colonoscopy
- •Known or suspected bowel obstruction or severe gastrointestinal motility disorder
- •Pregnancy or breastfeeding
- •Participation considered inappropriate by the investigators for clinical or safety reasons
研究组 & 干预措施
4 L PEG + bisacodyl
Participants receive 4 L polyethylene glycol (PEG) plus bisacodyl 12 mg before repeat colonoscopy after prior inadequate bowel preparation.
干预措施: Drug (Drug)
1 L PEG plus ascorbic acid + bisacodyl
Participants receive 1 L polyethylene glycol (PEG) plus ascorbic acid and bisacodyl 10 mg before repeat colonoscopy after prior inadequate bowel preparation.
干预措施: Drug (Drug)
2 L PEG + additional PEG
Participants receive 2 L polyethylene glycol (PEG) plus additional PEG administered during the 3 days before repeat colonoscopy after prior inadequate bowel preparation.
干预措施: Drug (Drug)
结局指标
主要结局
Adequate bowel preparation at repeat colonoscopy
时间窗: At repeat colonoscopy, on the day of the procedure
Proportion of participants with adequate bowel preparation at repeat colonoscopy, defined as a Boston Bowel Preparation Scale (BBPS) total score of 6 or higher, with a score of at least 2 in each colonic segment.
次要结局
- Total Boston Bowel Preparation Scale score at repeat colonoscopy(At repeat colonoscopy, on the day of the procedure)
- Right colon Boston Bowel Preparation Scale subscore(At repeat colonoscopy, on the day of the procedure)
- Transverse colon Boston Bowel Preparation Scale subscore(At repeat colonoscopy, on the day of the procedure)
- Left colon Boston Bowel Preparation Scale subscore(At repeat colonoscopy, on the day of the procedure)
- Participant satisfaction with bowel preparation(Assessed after bowel preparation and before or at repeat colonoscopy, on the day of the procedure)
- Polyp detection at repeat colonoscopy(At repeat colonoscopy, on the day of the procedure)
研究者
Giuseppe Scaglione
MD
Ospedale San Pio