Evaluation of Two Different Diet Regimen Prior to Colonoscopy in Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

184 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2016-04-30

Brief Summary

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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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Detailed Description

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Conditions

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Children Prior to Colonoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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low-fiber diet

Patients received low-fiber diet for 24 hours before colonoscopy

Group Type ACTIVE_COMPARATOR

polyethylene glycol 3350

Intervention Type 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.

clear liquid diet

Patients received clear liquid diet for 24 hours before colonoscopy

Group Type ACTIVE_COMPARATOR

polyethylene glycol 3350

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Forlax

Eligibility Criteria

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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

Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No