Evaluation of Two Different Diet Regimen Prior to Colonoscopy in Children

NCT02102373 | Completed

• 1 other identifier: Mytyk2014
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

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.

Conditions

Children Prior to Colonoscopy

Keywords

colonoscopy, pediatric, preparation, diet

Outcome Measures

Primary Outcomes (1)

• Bowel preparation of the whole colon

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

  in 15 minutes after colonoscopy

Secondary Outcomes (5)

• Bowel preparation for colon sections

  in 15 minutes after colonoscopy

• Duration of PEG taking

  in 15 minutes after colonoscopy

• Time between the last dose of PEG and colonoscopy

  in 15 minutes after colonoscopy

• Acceptability

  in the first 6 hours after colonoscopy

• Tolerability

  in the first 6 hours after colonoscopy

Study Arms (2)

low-fiber diet

ACTIVE COMPARATOR

Patients received low-fiber diet for 24 hours before colonoscopy

Device: polyethylene glycol 3350

clear liquid diet

ACTIVE COMPARATOR

Patients received clear liquid diet for 24 hours before colonoscopy

Device: polyethylene glycol 3350

Interventions

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.

Also known as: Forlax

clear liquid diet; low-fiber diet

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 6-18 years
• Elective colonoscopy

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Department of Pediatric Gastroenterology and Nutrition

Warsaw, 01-184, Poland

Location

Related Publications (1)

• Mytyk A, Lazowska-Przeorek I, Karolewska-Bochenek K, Kakol D, Banasiuk M, Walkowiak J, Albrecht P, Banaszkiewicz A. Clear Liquid Versus Low-fibre Diet in Bowel Cleansing for Colonoscopy in Children: A Randomized Trial. J Pediatr Gastroenterol Nutr. 2018 May;66(5):720-724. doi: 10.1097/MPG.0000000000001832.

  PMID: 29112090 DERIVED

Related Links

• Bowel preparation for colonoscopy: European Society of Gastrointestinal Endoscopy (ESGE) Guideline

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: March 26, 2014
• First Posted: April 2, 2014
• Study Start: March 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: April 25, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)