Efficacy, Safety and Tolerability of Different Bowel Preparation Before Colonoscopy in Children Over 2 Years Old

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

315 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-01

Study Completion Date

2021-05-30

Brief Summary

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Electronic colonoscopy plays an important role in the diagnosis and follow-up of intestinal diseases in children.

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Detailed Description

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The adequacy of bowel preparation before colonoscopy is particularly important for the visualization of intestinal mucosa under colonoscopy. Some studies have shown that bowel preparation must be customized according to the age, weight and clinical status of the child. However, there is no internationally recognized standard scheme for pediatric intestinal reserve. In pediatric clinical trials, polyethylene glycol with electrolyte solution (PEG-ELS) is more effective than bisacodyl, folium sennae and magnesium citrate. PEG-ELS is an electrolyte balanced isotonic solution, which can be used to clean the intestinal tract by large volume irrigation. Polyethylene glycol 4000 is a long-chain linear polymer, which can hardly absorb and decompose after oral administration. It can effectively increase the composition of intestinal fluid, stimulate intestinal peristalsis, cause watery diarrhea, and achieve the purpose of cleaning the intestine. The inorganic salt composition and proper amount of water in the formula ensure the balance of water and electrolyte exchange between intestinal tract and body fluid. In this study, PEG-ELS short protocol and long protocol were selected for intestinal preparation, and the effectiveness and safety of different intestinal preparation protocols under electronic colonoscopy for children over 2 years old were compared.

Conditions

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Child Obesity Bowel Preparation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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PEG-ELS-S

The dosage of PEG-ELS is given according to body weight: 10-15 kg, PEG-ELS 0.75 L; 15-22.5 kg, PEG-ELS 1.5 L; 22.5-30 kg, PEG-ELS 2.25 L; more than 30 kg, PEG-ELS 3 L.

Group Type EXPERIMENTAL

PEG-ELS-S

Intervention Type OTHER

2/3 dose of PEG-ELS was taken orally from the evening on the day before colonoscopy, and the remaining 1/3 dose of PEG-ELS was orally administered in the morning of the next day.

PEG-ELS-L

The dosage of PEG-ELS is given according to body weight: 10-15 kg, PEG-ELS 0.75 L; 15-22.5 kg, PEG-ELS 1.5 L; 22.5-30 kg, PEG-ELS 2.25 L; more than 30 kg, PEG-ELS 3 L.

Group Type ACTIVE_COMPARATOR

PEG-ELS-L

Intervention Type OTHER

PEG-ELS is given orally on the day before colonoscopy, which is divided into 10-12 portions and taken one portion every hour. If half of the total amount is not completed at afternoon ward round the day before colonoscopy, nasogastric feeding is recommended.

Interventions

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PEG-ELS-S

2/3 dose of PEG-ELS was taken orally from the evening on the day before colonoscopy, and the remaining 1/3 dose of PEG-ELS was orally administered in the morning of the next day.

Intervention Type OTHER

PEG-ELS-L

PEG-ELS is given orally on the day before colonoscopy, which is divided into 10-12 portions and taken one portion every hour. If half of the total amount is not completed at afternoon ward round the day before colonoscopy, nasogastric feeding is recommended.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Newly diagnosed children in Department of Gastroenterology at Children's Hospital of Fudan University
* According to the indications of electronic colonoscopy, colonoscopy was performed for the first time
* Age: 2-22 years old

Exclusion Criteria

* Having contraindications of electronic colonoscopy
* Having contraindications of general anesthesia
* Previous abdominal surgery
* Chronic constipation
* There is evidence of intestinal stenosis and gastrointestinal malformation
* Laxatives or drugs in the intestinal preparation protocol of this study have been used before bowel preparation
* Disagree the use of the bowel preparation protocol developed in the study

Minimum Eligible Age

2 Years

Maximum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No