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OpenTrials
Completed

NCT Number: NCT02102373

Evaluation of Two Different Diet Regimen Prior to Colonoscopy in Children

Colonoscopy is a routinely performed procedure in children and adolescents. Proper visualization of the intestinal mucosa is highly dependent on the quality of the bowel preparation. European Society of Gastrointestinal Endoscopy (ESGE) emphasizes that the timing of bowel preparation is the key factor and recommends that the delay between the last dose of bowel preparation and colonoscopy should be minimized. Timing of bowel preparation prior to colonoscopy has not been studied in children population, yet. The diet regimen before colonoscopy is likely less important than the timing of bowel preparation, however may influence the well-being of children.

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Key information

Conditions

Children Prior to Colonoscopy

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Pediatric Gastroenterology and Nutrition

Warsaw, 01-184, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 6-18 years
  • Elective colonoscopy

Exclusion criteria

  • Chronic renal, liver, or heart failure
  • Acute surgical abdominal conditions (e.g., acute obstruction or perforation)
  • Acute surgical abdominal conditions (e.g., acute obstruction or perforation)
  • Any prior gastrointestinal surgery

Treatment and study plan

polyethylene glycol 3350

Device

Patients received a polyethylene glycol 3350 solution starting at afternoon the day before the colonoscopy at a dose of 1000 ml/15 kg (maximum 4 L). The patients were instructed to drink all solution in about 4-6 hours.

Other names: Forlax

Primary outcomes

  1. Bowel preparation of the whole colon

    Time frame: in 15 minutes after colonoscopy

    Boston bowel preparation score for the whole colon assessed by the endoscopist in 15 minutes after the procedure

Secondary outcomes

  1. Bowel preparation for colon sections

    Time frame: in 15 minutes after colonoscopy

    Boston bowel preparation score for:

    • the right side of the colon
    • the transverse section of the colon
    • the left side of the colon assessed by the endoscopist in 15 minutes after the colonoscopy

  2. Duration of PEG taking

    Time frame: in 15 minutes after colonoscopy

  3. Time between the last dose of PEG and colonoscopy

    Time frame: in 15 minutes after colonoscopy

  4. Acceptability

    Time frame: in the first 6 hours after colonoscopy

    Patient's satisfaction of bowel preparation measured by 10-point visual-analogue scale (VAS)

  5. Tolerability

    Time frame: in the first 6 hours after colonoscopy

    Tolerability assessment was based on the recording of occurrence and severity of GI symptoms such as nausea, bloating, abdominal, pain/cramps and anal discomfort

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Registry information

Official study title

Clear Liquid vs Low-fiber Diet in Bowel Cleansing for Colonoscopy in Children: a Randomized Trial

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 2, 2014
Registry last updated
Apr 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.