Randomized Controlled Trial Comparing Split-versus Standard-dose Sodium Pico Sulfate Plus Magnesium Citrate for Bowel Cleansing Before Colonoscopy in Children
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 590
- 主要终点
- Best Colonic Cleansing in 590 pediatric patient underwent colonoscopy
研究概览
简要总结
Before having a colonoscopy, it is necessary to clean the intestine well in order to have a complete view of the intestinal mucosa. Preparations consisting of osmotic agents are used to clean the intestines, which are sometimes difficult to drink. In this study we want to evaluate whether the preparation, based on sodium picosulfate plus magnesium citrate (PMC), is easier for the patient to take all day before the exam or half the day before and half the same morning of procedure and which method of intake allows the doctor to better conduct the examination.
The primary objective of this study will be to compare the efficacy, tolerability and acceptability of two dosage regimens of sodium picosulfate plus magnesium citrate (PMC). Effectiveness means which of the two methods of taking the preparation works best for cleaning the intestine, with tolerability if one of the two methods is easier for the patient and with acceptability if one of the two methods is easier than the other.
详细描述
The primary aim of this investigator-blinded, randomized, controlled trial (RCT) will be to compare the efficacy, tolerability and acceptability of two PMC dosing regimen (standard regimen vs split-dose regimen).
The secondary aims are the following:
- evaluation of adverse events;
- assessment of symptoms associated to colonic lavage solutions;
- monitoring the ease of taking the preparation;
- identification of patients' willingness to repeat the procedure;
- evaluation of the amount of preparation voluntarily taken by patients.
Endpoints
Primary end-points will be the overall colon cleansing defined as the rate of "successful" cleansing (excellent and good scores in the BBPS, i.e. ≥ 6 points) of the two preparation regimen.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children aged 2-18 years undergoing elective colonoscopy
排除标准
- •requirement for urgent colonoscopy
- •bowel obstruction,
- •known or suspected hypersensitivity to the active or other ingredients
- •clinically significant electrolyte imbalance
- •prior intestinal resection
- •known metabolic, renal and cardiac disease.
研究组 & 干预措施
group A (PMC standard-dose)
Group A (PMC standard-dose): patients will receive two oral doses of sodium picosulphate plus magnesium oxide and citric acid (Picoprep), each diluted in 150 ml of water, at 17:00 and 4 hours later in the evening prior to the colonoscopy (¼ sachet for children < 6 years, ½ sachet for children 6-12 years, and one sachet for children >12 years). Intake of at least 40-50 ml/kg (maximum 2 L) of clear fluids (cold tea, gatorade etc..) will be recommended after each dose. The age-adjusted dosage is dictated by the instructions of the manufacturing company. No solid food intake will be allowed during the 24 hours prior to the examination according to the instructions of the manufacturing company.
干预措施: split dose vs standard dose of sodium pico sulfate plus magnesium sulfate in children for bowel cleansing (Drug)
Group B (PMC split-dose)
Group B (PMC split-dose): patients will receive the first oral doses of PMC diluted in 150 ml of water (Picoprep; Ferring Italia, Milan, Italy) at 19:00 of the day before colonoscopy and the second one at 06:00 hours on the morning of the day of colonoscopy (¼ sachet for children < 6 years, ½ sachet for children 6-12 years, and one sachet for children >12 years). Intake of at least 40-50 ml/kg (maximum 2 L) of clear fluids (cold tea, gatorade etc..) will be recommended after each dose. The age-adjusted dosage is dictated by the instructions of the manufacturing company. No solid food intake will be allowed during the 24 hours prior to the examination according to the instructions of the manufacturing company.
干预措施: split dose vs standard dose of sodium pico sulfate plus magnesium sulfate in children for bowel cleansing (Drug)
结局指标
主要结局
Best Colonic Cleansing in 590 pediatric patient underwent colonoscopy
时间窗: 18 months
Primary outcome will be the overall colon cleansing defined as the rate of successful cleansing (excellent and good scores in the BBPS, i.e. ≥ 6 points) of the two preparation regimen.
次要结局
- the rate of specific symptoms associated to colonic lavage solutions(18 months)
- the rate of children who declared that they would be willing to repeat the same preparation regimen if needed(18 months)
- the rate of adverse events(18 months)
- the rate of children who declared that the intake of the solution was easy(18 months)
- the rate of children taking an amount of solution ≥ 75%(18 months)
研究者
Dr. Enrico Felici
Head of Pediatric Unit
Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria