- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04525560
Efficacy, Safety and Tolerability of Different Bowel Preparation Before Colonoscopy in Children Over 2 Years Old
October 8, 2021 updated by: Children's Hospital of Fudan University
Electronic colonoscopy plays an important role in the diagnosis and follow-up of intestinal diseases in children.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
315
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Shanghai
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Shanghai, Shanghai, China, 201102
- Children's Hospital of Fudan University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 22 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
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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.
|
Active Comparator: 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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bowel cleansing
Time Frame: During the operation of electronic colonoscopy (about 15 min )
|
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.
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During the operation of electronic colonoscopy (about 15 min )
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Compliance with polyethylene glycol with electrolyte solution (PEG-ELS)
Time Frame: During bowel preparation (about 24 hours)
|
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.
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During bowel preparation (about 24 hours)
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Adverse reactions receiving polyethylene glycol with electrolyte solution
Time Frame: During bowel preparation (about 24 hours)
|
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.
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During bowel preparation (about 24 hours)
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Rate of nasal feeding PEG-ELS
Time Frame: During bowel preparation (about 24 hours)
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Rate of nasal feeding PEG-ELS.
Nasogastric feeding is recommended for those who cannot complete the prescribed amount.
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During bowel preparation (about 24 hours)
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Enema rate before colonoscopy
Time Frame: immediately before colonoscopy
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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.
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immediately before colonoscopy
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Times of washing under colonoscopy
Time Frame: During the operation of electronic colonoscopy (about 15 mins)
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If the visual field is not clear, it should be washed during the operation of electronic colonoscopy.
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During the operation of electronic colonoscopy (about 15 mins)
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Adverse events
Time Frame: up to 30 minutes after colonoscopy
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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.
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up to 30 minutes after colonoscopy
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2020
Primary Completion (Actual)
May 30, 2021
Study Completion (Actual)
May 30, 2021
Study Registration Dates
First Submitted
August 21, 2020
First Submitted That Met QC Criteria
August 24, 2020
First Posted (Actual)
August 25, 2020
Study Record Updates
Last Update Posted (Actual)
October 11, 2021
Last Update Submitted That Met QC Criteria
October 8, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BP/2+
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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