Overview

Picoprep Split-dose Before Colonoscopy in Children

Status:
Not yet recruiting

Trial end date:
2022-07-16

Target enrollment:
0

Participant gender:
All

Summary

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.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Azienda Ospedaliera "Sant'Andrea"

Treatments:

Magnesium Sulfate

Criteria

Inclusion Criteria:

• children aged 2-18 years undergoing elective colonoscopy

Exclusion Criteria:

- 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.