Colon Cleansing Efficacy With 1L PEG Versus 2L PEG and 4L PEG for Colonoscopy Among Inpatients: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 846
- 试验地点
- 1
- 主要终点
- Proportion of patients with adequate colon cleansing
研究概览
简要总结
An adequate level of bowel preparation before colonoscopy has an extremely relevant impact on lesion detection and procedure success. The inpatient status represents a well-known independent predictor for inadequate colon cleansing. A recent prospective, multicentre, Italian study among inpatients showed that an adequate colon cleansing was achieved in 60-70% of patients, far below the ideal threshold of 90%. Interestingly, a higher rate of adequate colon cleansing was reported for a very low-volume (1L) polyethylene glycol (PEG)-based preparation when compared to 4L and 2L PEG-based solutions. However, this finding has to be confirmed as the study was not controlled and the PEG-1L group was much smaller than the other two.
Aim of the present multicenter randomized controlled study will be to assess and compare the efficacy and safety of a novel very-low volume (1L) PEG-based preparation vs. standard-of-care low-volume (2L) and high-volume (4L) PEG-based purge, among inpatients who undergo colonoscopy.
详细描述
An adequate level of bowel preparation before colonoscopy has an extremely relevant impact on lesion detection and procedure success. The inpatient status represents a well-known independent predictor for inadequate colon cleansing. A recent prospective, multicentre, Italian study among inpatients showed that an adequate colon cleansing was achieved in 60-70% of patients, far below the ideal threshold of 90%. Such a low efficacy has several negative consequences: first, it leads to repetition of colonoscopy, therefore prolonging patients' in-hospital stay and increasing the risk of adverse events and costs; second, it augments the risk of missing colorectal lesions, negatively affecting patients' management and increasing costs due to the need for adjunctive diagnostic studies.
Current recommendations on bowel preparation among difficult-to-prepare patients are mostly based on expert opinions, the high-volume 4L polyethylene glycol (PEG)-based prep being considered as the gold standard, possibly with further additional solution. On the other hand, compliance to the bowel preparation has been related to an adequate colon cleansing, and it may be argued that inpatients might find it difficult to take high-volume purge. A recent Italian prospective multicentre study among inpatients showed similar rates of adequate bowel preparation between patients who underwent bowel preparation with and without additional solution. Interestingly, a higher rate of adequate colon cleansing was reported for a very low-volume (1L) polyethylene glycol (PEG)-based preparation when compared to 4L and 2L PEG-based solutions. However, this finding has to be confirmed as the study was not controlled and the PEG-1L group was much smaller than the other two.
Aim of the present randomized multicenter controlled study will be to assess and compare the efficacy and safety of a novel very-low volume (1L) PEG-based preparation vs. standard-of-care low-volume (2L) and high-volume (4L) PEG-based purge, among inpatients.
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)
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
- •Inpatients scheduled for elective colonoscopy
- •bowel preparation performed inside the hospital
- •≥18 years old
排除标准
- •known or suspected ileus
- •gastrointestinal obstruction
- •gastric retention
- •bowel perforation
- •toxic colitis, or megacolon
- •phenylketonuria
- •glucose-6-phosphate dehydrogenase deficiency
- •active intestinal bleeding
- •emergency colonoscopy
- •dementia or illness requiring nasogastric tube for bowel prep administration
- •refusal to participate or inability to sign the informed consent
研究组 & 干预措施
1L PEG
Patients will be prepared with 1L-PEG-based bowel preparation.
干预措施: NER1006 (Drug)
2L PEG
Patients will be prepared with 2L-PEG-based bowel preparation.
干预措施: MoviPrep (Drug)
4L PEG
Patients will be prepared with 4L-PEG-based bowel preparation.
干预措施: Macrogol 400 (Drug)
结局指标
主要结局
Proportion of patients with adequate colon cleansing
时间窗: During the procedure.
Efficacy will be assessed as the percentage of patients with adequate bowel cleansing, as rated according to the Boston Bowel Preparation Scale (BBPS). This scale gives 0-3 points to each of the three colonic segments (i.e. right colon, transverse colon, and left colon); 0 points are assigned for the worst segment cleansing, whereas at least 2 points stand for adequate segment cleansing. Adequate colon cleansing is defined when at least 2 points are reached in each colonic segment.
次要结局
未报告次要终点
研究者
Lorenzo Fuccio
Professor of Gastroenterology
University of Bologna