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Picoprep Split-dose Before Colonoscopy in Children

NCT04767633 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 590

Last updated 2021-02-23

No results posted yet for this study

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.

Conditions

  • Sodium Picosulfate Overdose
  • Magnesium Sulfate Overdose
  • Children, Only
  • Bowel Disease

Interventions

DRUG

split dose vs standard dose of sodium pico sulfate plus magnesium sulfate in children for bowel cleansing

The preparations will be dispensed by a nurse who carefully explained how the products should be taken, emphasising the importance of complete intake of the solution to ensure a safe and effective procedure. Moreover, each patient will be provided with dietary instructions: low residue diet for 3 days before colonoscopy. During and after bowel preparation, solid food will not be allowed. Clear liquid could be taken until 2 hours before the procedure. All colonoscopy will be performed between 11:00 and 15:00 by two endoscopists.

Sponsors & Collaborators

  • Azienda Ospedaliera "Sant'Andrea"

    lead OTHER

Principal Investigators

  • Enrico Felici, DR · Azienda Ospedaliera SS. Antonio e Biagio e C. Arrigo - Alessandria

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-30
Primary Completion
2022-04-16
Completion
2022-07-16

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04767633 on ClinicalTrials.gov