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

NCT04525560 | Completed DMC

• 1 other identifier: BP/2+
• Study Type: interventional
• Target: 315
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Child Obesity; Bowel Preparation

Keywords

Child; Electronic colonoscopy; bowel preparation; polyethylene glycol with electrolyte solution

Outcome Measures

Primary Outcomes (1)

• Bowel cleansing

  Bowel cleansing was assessed by Boston bowel preparation scale (BBPS). The scores of left, middle and right colon were added up to the total score of BBPS, with the lowest score of 0 and the highest score of 9. The score of 8-9 represents excellent bowel preparation, 6-7 represents good, 4-5 represents average, and 0-3 represents poor. Excellent and good for intestinal preparation are qualified, general and poor for intestinal preparation are unqualified.

  During the operation of electronic colonoscopy (about 15 min )

Secondary Outcomes (6)

• Compliance with polyethylene glycol with electrolyte solution (PEG-ELS)

  During bowel preparation (about 24 hours)

• Adverse reactions receiving polyethylene glycol with electrolyte solution

  During bowel preparation (about 24 hours)

• Rate of nasal feeding PEG-ELS

  During bowel preparation (about 24 hours)

• Enema rate before colonoscopy

  immediately before colonoscopy

• Times of washing under colonoscopy

  During the operation of electronic colonoscopy (about 15 mins)

Study Arms (2)

PEG-ELS-S

EXPERIMENTAL

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.

Other: PEG-ELS-S

PEG-ELS-L

ACTIVE COMPARATOR

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.

Other: PEG-ELS-L

Interventions

PEG-ELS-S 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-S

PEG-ELS-L 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.

PEG-ELS-L

Eligibility Criteria

• Age: 2 Years - 22 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Study Sites (1)

Children's hospital of Fudan university

Shanghai, Shanghai Municipality, 201102, China

Location

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2020
• First Posted: August 25, 2020
• Study Start: August 1, 2020
• Primary Completion: May 30, 2021
• Study Completion: May 30, 2021
• Last Updated: October 11, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)