NCT04525560

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 315 (actual)
• Sponsor: Children's Hospital of Fudan University · Academic / Other
• Sex: All
• Age: 2 Years – 22 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Child Obesity
• Bowel Preparation

Interventions

Type	Name	Description
OTHER	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.
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.

Timeline

• Start date: 2020-08-01
• Primary completion: 2021-05-30
• Completion: 2021-05-30
• First posted: 2020-08-25
• Last updated: 2021-10-11

Locations

1 site across 1 country: China