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

Bowel Preparation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04525560
• Other study ID #: BP/2+
• Status: Completed
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: May 30, 2021

Study information

• Verified date: October 2021
• Source: Children's Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 315
• Est. completion date: May 30, 2021
• Est. primary completion date: May 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 22 Years

Eligibility

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

Related Conditions & MeSH terms

• Bowel Preparation
• Child Obesity
• Pediatric Obesity

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Children's hospital of Fudan university	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Compliance with polyethylene glycol with electrolyte solution (PEG-ELS)	This variable is a binary variables (good/poor). Poor compliance was defined as PEG-ELS dosage less than 75% of the prescribed dose. Good compliance was defined as PEG-ELS dosage more than 75% of the prescribed dose. Prescribed dose and actually oral dose were recorded by nurse.	During bowel preparation (about 24 hours)
Secondary	Adverse reactions receiving polyethylene glycol with electrolyte solution	This variable is a binary variables (Yes/No). The variable would be set to "Yes" as any adverse reactions including Nausea, vomiting, abdominal distension, abdominal pain or allergic to PEG-ELS appeared during bowel preparation.	During bowel preparation (about 24 hours)
Secondary	Rate of nasal feeding PEG-ELS	Rate of nasal feeding PEG-ELS. Nasogastric feeding is recommended for those who cannot complete the prescribed amount.	During bowel preparation (about 24 hours)
Secondary	Enema rate before colonoscopy	At 8 am on the day of electronic colonoscopy, no food and water were given from 8 am. At 11 am on the day of colonoscopy, the last assessment of stool was conducted. If the Bristol stool form scale (BSFS) = 5 points, colonoscopy should be cancelled and bowel preparation time should be prolonged; if BFSF = 6 points, Warm normal saline (50 ml/kg) was given for enema; if BFSF = 7 points, no enema.	immediately before colonoscopy
Secondary	Times of washing under colonoscopy	If the visual field is not clear, it should be washed during the operation of electronic colonoscopy.	During the operation of electronic colonoscopy (about 15 mins)
Secondary	Adverse events	It is a repeated measured variable. This variable is a binary variables (Yes/No). The variable would be set to "Yes" as any adverse reactions. An adverse event refers to the event that occurs after a patient in a clinical study accepts a research-based product, which does not necessarily have a causal relationship with the test product. Adverse events are diseases, signs or symptoms (including abnormal laboratory results) that occur or worsen during the course of the study.	up to 30 minutes after colonoscopy