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Evaluation of Two Different Diet Regimen Prior to Colonoscopy in Children

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ClinicalTrials.gov Identifier: NCT02102373
Recruitment Status : Completed
First Posted : April 2, 2014
Last Update Posted : April 25, 2017
Sponsor:
Information provided by (Responsible Party):
Aleksandra Banaszkiewicz, Medical University of Warsaw

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Children Prior to Colonoscopy Device: polyethylene glycol 3350 Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 184 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Clear Liquid vs Low-fiber Diet in Bowel Cleansing for Colonoscopy in Children: a Randomized Trial
Study Start Date : March 2014
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: low-fiber diet
Patients received low-fiber diet for 24 hours before colonoscopy
Device: polyethylene glycol 3350
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 Name: Forlax
Active Comparator: clear liquid diet
Patients received clear liquid diet for 24 hours before colonoscopy
Device: polyethylene glycol 3350
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 Name: Forlax



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02102373


Locations
Poland
Department of Pediatric Gastroenterology and Nutrition
Warsaw, Poland, 01-184
Sponsors and Collaborators
Medical University of Warsaw

Additional Information:
Responsible Party: Aleksandra Banaszkiewicz, MD PhD, Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT02102373     History of Changes
Other Study ID Numbers: Mytyk2014
First Posted: April 2, 2014    Key Record Dates
Last Update Posted: April 25, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Aleksandra Banaszkiewicz, Medical University of Warsaw:
colonoscopy, pediatric, preparation, diet

Additional relevant MeSH terms:
Polyethylene glycol 3350
Laxatives
Gastrointestinal Agents