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Randomized Controlled Trial Comparing Split-versus Standard-dose Sodium Pico Sulfate Plus Magnesium Citrate for Bowel Cleansing Before Colonoscopy in Children
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.
Details
| Lead sponsor | Azienda Ospedaliera "Sant'Andrea" |
|---|---|
| Phase | Phase 3 |
| Status | UNKNOWN |
| Enrolment | 590 |
| Start date | 2021-04 |
| Completion | 2022-07-16 |
Conditions
- Sodium Picosulfate Overdose
- Magnesium Sulfate Overdose
- Children, Only
- Bowel Disease
Interventions
- split dose vs standard dose of sodium pico sulfate plus magnesium sulfate in children for bowel cleansing
Primary outcomes
- Best Colonic Cleansing in 590 pediatric patient underwent colonoscopy — 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.