Comparison of Bowel Cleansing Efficacy Between Same-day Dose Versus Split Dose

August 12, 2020 updated by: Tae-Geun Gweon, Incheon St.Mary's Hospital

Comparison of Bowel Cleansing Efficacy Between Same-day Dose Versus Split Dose : A Single Center, Operator Blinded, Prospective Randomized Controlled Trial

Split dose bowel cleansing is recommended method for colonoscopy. For afternoon colonoscopy, same-day dose of bowel cleansing is alternative option. Recently, same-day bowel cleansing for morning colonoscopy was validated. To date, there was no study which compared the bowel cleansing efficacy between same-day dose and split dose regardless of colonoscopy time. The aim of current study is to compare the bowel cleansing efficacy, adverse events, and patient's tolerability between the two group.

Subjects who underwent colonoscopy for various reasons were included. After agreeing to participate in the study, study participants were randomly assigned to split dose or same day dose group. Bowel cleansing is done using polyethylene glycol (PEG). All colonoscopy was done between 10 AM to 6 PM. Study participants were instructed to ingest 500ml PEG every 15 minutes. Subjects who were assigned to split dose group ingested 2L PEG from 9PM 1 day before colonoscopy. Remaining 2L PEG was ingested 3-5 hours before colonoscopy. In the same-day dose group, bowel cleansing was started from 5AM for subjects who were scheduled to receive colonoscopy in the morning. Afternoon colonoscopy group in the same-day dose group ingested 2L PEG from 5AM. Remaining 2L PEG was finished 3-5 hours before colonoscopy.

Bowel cleansing efficacy was assessed using Boston bowel preparation scale. Vital signs and laboratory tests were checked before colonoscopy. Study participants completed questionnaire which contained patient's satisfaction, tolerability, and adverse event during bowel cleansing. Bowel cleansing efficacy, patient's tolerability, and safety profile were compared between the two groups. Successful bowel cleansing was estimated 85% for split dose group.

The investigators set 10% for inferior margin. Considering 10% drop out, a total of 352 subjects will be recruited.

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

Randomization and blinding:

Randomization will be done using computer generated randomization list. A specialized nurse will explain the method of bowel cleansing. Investigators (endoscopists) are blinded to bowel cleansing method.

Endpoint:

Primary end point is successful bowel cleansing rated by Boston bowel preparation (BBPS) scale. Successful bowel cleansing is defined as all segment is 2 or 3 points. Endoscopists will assess BBPS when colonoscopy withdrawal.

Secondary end point was patient's tolerability and safety profile including adverse events. Patient's satisfaction to the different bowel cleansing method and adverse events (nausea, vomiting, dizziness, fatigue) will be investigated by questionnaire before colonoscopy. Blood test will be done before colonoscopy.

Statistical analysis:

Bowel cleansing success, patient's tolerability and safety profile will be compared between the two groups. Student t test for continuous variables and the chi-square test or Fisher exact test for categorical variables.

Sample size:

This study is non-inferioty study. Assuming bowel cleansing success rate 85% in the split-dose group, the significant difference between the two groups were hypothesized at 10%. Considering 80% power and 10% drop rate, a total of 352 participants is needed.

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.
352

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.
  • Phase 3

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

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

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • all subjects who undergo colonoscopy for various reasons.

Exclusion Criteria:

  • hemodynamic instability
  • ileus or bowel obstruction
  • active inflammatory bowel disease
  • advanced colon cancer

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

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: Same-day dose group
Participants who ingest bowel cleanser on the day of colonoscopy. Participant will ingest the 4L PEG on the day of colonoscopy.
Drug: Polyethylene Glycol (PEG)
Different method for bowel cleansing using same bowel cleanser. Same-day dose group : 4L PEG will be ingested on the day of colonoscopy Spli-dose group : 2L PEG will be ingested 1 day before colonoscopy, remaining 2L PEG will be ingested on the day of colonoscopy
Other Names:
  • colyte
Active Comparator: Split-dose group
Participants who ingest bowel cleanser by split dose. 2L PEG will be ingested 1 day before colonoscopy. Remaining 2L bowel cleanser will be ingested on the day of colonoscopy.
Drug: Polyethylene Glycol (PEG)
Different method for bowel cleansing using same bowel cleanser. Same-day dose group : 4L PEG will be ingested on the day of colonoscopy Spli-dose group : 2L PEG will be ingested 1 day before colonoscopy, remaining 2L PEG will be ingested on the day of colonoscopy
Other Names:
  • colyte

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
Boston Bowel Preparation Scale
Time Frame: Bowel cleansing efficacy using Boston bowel preparation scale will be assessed during colonoscopy withdrawal

Primary endpoint=Successful bowel cleansing (all segmental score 2 or above)

* Boston bowel preparation scale (0-9) Sum of 3 segment of bowel. 0=inadequate

  1. poor
  2. good
  3. excellent
Bowel cleansing efficacy using Boston bowel preparation scale will be assessed during colonoscopy withdrawal

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.
Incheon St.Mary's Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Tae-Geun Gweon, Ph.D, PROFESSOR

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.
May 1, 2017

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.
February 28, 2018

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.
February 28, 2018

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).
October 17, 2017

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.
October 17, 2017

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.
October 20, 2017

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.
August 13, 2020

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.
August 12, 2020

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.
August 1, 2020

More Information

Terms related to this study

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.
  • OC17MESI0060

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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