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

Fudan University

Status: Completed

Conditions: Bowel Preparation; Child Obesity

Treatments: Other: PEG-ELS-L; Other: PEG-ELS-S

Study type: Interventional

Funder types: Other

Identifiers

NCT04525560

BP/2+

Details and patient eligibility

About

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

Full description

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.

Enrollment: 315 patients

Sex: All

Ages: 2 to 22 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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315 participants in 2 patient groups

PEG-ELS-S

Experimental group

Description:

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.

Treatment:

Other: PEG-ELS-S

PEG-ELS-L

Active Comparator group

Description:

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.

Treatment:

Other: PEG-ELS-L