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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Same-day dose group | Experimental | Participants who ingest bowel cleanser on the day of colonoscopy. Participant will ingest the 4L PEG on the day of colonoscopy. |
|
| Split-dose group | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polyethylene Glycol (PEG) | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Boston Bowel Preparation Scale | 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
| Bowel cleansing efficacy using Boston bowel preparation scale will be assessed during colonoscopy withdrawal |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tae-Geun Gweon, Ph.D | Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Incheon St. Mary's Hospital | Incheon | 02143 | South Korea |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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 |
| FG001 | 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. 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Participants who ingested bowel cleansing agent according to protocol
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Boston Bowel Preparation Scale | 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
| Posted | Number | Number of successful cleansing | Bowel cleansing efficacy using Boston bowel preparation scale will be assessed during colonoscopy withdrawal |
|
Adverse events were collected between enrollment and 4 weeks of procedure
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adverse events related to bowel cleanser | Gastrointestinal disorders | Systematic Assessment | nausea |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Tae-Geun Gweon | College of Medicine, The Catholic University of Korea | 82 32 340 2228 | gweontae@naver.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 18, 2019 | Jul 28, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011092 | Polyethylene Glycols |
| C033608 | Golytely |
| ID | Term |
|---|---|
| D005026 | Ethylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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|
|
| BG001 | 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. 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| 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. 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 |
|
|
| 0 |
| 172 |
| 0 |
| 172 |
| 73 |
| 172 |
| EG001 | 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. 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 | 0 | 167 | 0 | 167 | 67 | 167 |
|
| Adverse events related to bowel cleansing agent | Gastrointestinal disorders | Systematic Assessment | vomiting |
|
| Adverse events related to bowel cleansing agent | Gastrointestinal disorders | Systematic Assessment | bloating |
|
| Adverse events related to bowel cleansing agent | Nervous system disorders | Systematic Assessment | Headache, dizziness |
|
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| D011108 |
| Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |