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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
315

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 201102
        • Children's Hospital of Fudan University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
During the operation of electronic colonoscopy (about 15 min )

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
During bowel preparation (about 24 hours)
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.
During bowel preparation (about 24 hours)
Rate of nasal feeding PEG-ELS
Time Frame: During bowel preparation (about 24 hours)
Rate of nasal feeding PEG-ELS. Nasogastric feeding is recommended for those who cannot complete the prescribed amount.
During bowel preparation (about 24 hours)
Enema rate before colonoscopy
Time Frame: immediately 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
Times of washing under colonoscopy
Time Frame: During the operation of electronic colonoscopy (about 15 mins)
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)
Adverse events
Time Frame: up to 30 minutes after colonoscopy
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Children's Hospital of Fudan University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 21, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 25, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 11, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 8, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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