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

Primary Purpose

Child Obesity, Bowel Preparation

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
PEG-ELS-S
PEG-ELS-L
Sponsored by
Children's Hospital of Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Child Obesity focused on measuring Child, Electronic colonoscopy, bowel preparation, polyethylene glycol with electrolyte solution

Eligibility Criteria

2 Years - 22 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Children's hospital of Fudan university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PEG-ELS-S

PEG-ELS-L

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Rate of nasal feeding PEG-ELS
Rate of nasal feeding PEG-ELS. Nasogastric feeding is recommended for those who cannot complete the prescribed amount.
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.
Times of washing under colonoscopy
If the visual field is not clear, it should be washed during the operation of electronic colonoscopy.
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.

Full Information

First Posted
August 21, 2020
Last Updated
October 8, 2021
Sponsor
Children's Hospital of Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT04525560
Brief Title
Efficacy, Safety and Tolerability of Different Bowel Preparation Before Colonoscopy in Children Over 2 Years Old
Official Title
Efficacy, Safety and Tolerability of Different Bowel Preparation Before Colonoscopy in Children Over 2 Years Old
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
May 30, 2021 (Actual)
Study Completion Date
May 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Child Obesity, Bowel Preparation
Keywords
Child, Electronic colonoscopy, bowel preparation, polyethylene glycol with electrolyte solution

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
315 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PEG-ELS-S
Arm Type
Experimental
Arm 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.
Arm Title
PEG-ELS-L
Arm Type
Active Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
PEG-ELS-S
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
PEG-ELS-L
Intervention Description
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.
Primary Outcome Measure Information:
Title
Bowel cleansing
Description
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.
Time Frame
During the operation of electronic colonoscopy (about 15 min )
Secondary Outcome Measure Information:
Title
Compliance with polyethylene glycol with electrolyte solution (PEG-ELS)
Description
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.
Time Frame
During bowel preparation (about 24 hours)
Title
Adverse reactions receiving polyethylene glycol with electrolyte solution
Description
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.
Time Frame
During bowel preparation (about 24 hours)
Title
Rate of nasal feeding PEG-ELS
Description
Rate of nasal feeding PEG-ELS. Nasogastric feeding is recommended for those who cannot complete the prescribed amount.
Time Frame
During bowel preparation (about 24 hours)
Title
Enema rate before colonoscopy
Description
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.
Time Frame
immediately before colonoscopy
Title
Times of washing under colonoscopy
Description
If the visual field is not clear, it should be washed during the operation of electronic colonoscopy.
Time Frame
During the operation of electronic colonoscopy (about 15 mins)
Title
Adverse events
Description
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.
Time Frame
up to 30 minutes after colonoscopy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Children's hospital of Fudan university
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201102
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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

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