Phase 4 Study of Comparison of 2-Liter Mixed Preparation With Bisacodyl Plus Polyethylene Glycol and 4-Liter Polyethylene Glycol for Colon Cleansing in Patients With Prior History of Colorectal Resection. A Prospective Randomized Controlled Trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 116
- 试验地点
- 2
- 主要终点
- quality of bowel preparation rated according to a modified Ottawa bowel preparation scale
研究概览
简要总结
Studies that have investigated different bowel preparations in patients with history of colorectal surgery are surprisingly lacking.Therefore, which is the best colon preparation in this subgroup of patients is still unknown. Polyethylene glycol (PEG)-based solutions are the most popular and safest bowel preparation regimens, however the 4-Liter volume is often poorly tolerated. More recently, it has been shown that the use of a low volume preparation (2-Liter PEG solution with the adjunct of a laxative, bisacodyl) achieves comparable bowel cleanliness rates to 4-Liter PEG in general population.The primary aim will be to compare the efficacy of 2-L mixed preparation (bisacodyl plus PEG) to 4-L PEG 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 (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
- •Outpatients
- •≥18 yrs old,
- •Prior history of colorectal resection due to colo-rectal cancer, referred for surveillance colonoscopy
排除标准
- •Emergency Colonoscopy
- •Comorbidities: Congestive heart failure, history of kidney disease, history of solid organ transplant
- •Pregnant and/or lactating women
研究组 & 干预措施
bisacodyl plus 2-Liter Polyethylene glycol
Patients randomized to the low-volume arm, will be invited to consume 2 sachets of Lovol-esse (Polyethylene glycol) in one liter of water at 8:00 PM the evening before the colonoscopy and 2 sachets in one liter of water 4 hours before their scheduled colonoscopy appointment; furthermore, the patients will be instructed to take three 5-mg tablets of bisacodyl the day before the procedure, at 5:00 PM.
干预措施: Polyethylene glycol (Drug)
bisacodyl plus 2-Liter Polyethylene glycol
Patients randomized to the low-volume arm, will be invited to consume 2 sachets of Lovol-esse (Polyethylene glycol) in one liter of water at 8:00 PM the evening before the colonoscopy and 2 sachets in one liter of water 4 hours before their scheduled colonoscopy appointment; furthermore, the patients will be instructed to take three 5-mg tablets of bisacodyl the day before the procedure, at 5:00 PM.
干预措施: Bisacodyl (Drug)
4-Liter Polyethylene glycol
Patients assigned to the high-volume arm will be invited to consume 2 envelopes of Selg-esse 1000 (polyethylene glycol) in 2 litres of water and drink the resulting solution in about 2-3 hours starting at 6:00 PM the evening before the colonoscopy; the day of the procedure, starting 5 hours before the procedure, the patients will be invited to complete the preparation with 2 others envelopes of Selg-esse 1000 (polyethylene glycol) dissolved in 2 litres of water.
干预措施: Polyethylene glycol (Drug)
结局指标
主要结局
quality of bowel preparation rated according to a modified Ottawa bowel preparation scale
时间窗: about 2 weeks after the randomization
次要结局
- Tolerability to the preparation (specific questionaire)(participants will be followed from the randomization until the time of colonoscopy, about 2 weeks after the randomization)
- safety (adverse event rate)(participants will be followed from the randomization until the time of colonoscopy, about 2 weeks after the randomization)
- Lesion detection (type and lesion detection rate/patient)(about 2 weeks from the randomization)
研究者
Alessandro Mussetto
MD
Ospedale Santa Maria delle Croci