Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the efficacy and the acceptability of low-residue diet package (Enimaclin®) as diet control before colonoscopy.
In this study, we investigate a randomized, single-blinded, comparative study to evaluate the efficacy and the acceptability of low-residue diet package (Enimaclin®) as diet control before colonoscopy.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| low-residue diet package (Enimaclin®) | Experimental | Low-residue diet package with normal amount 2L PEG-ELS |
|
| Self-controlled diet | Placebo Comparator | Self-controlled diet with normal amount of 2L PEG-ELS |
|
| Low-residue diet (Enimaclin®) package | Experimental | Low-residue diet package with low volume 1.5L PEG-ELS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enimaclin® | Dietary Supplement | Enimaclin Colomil ® (Glico Co., Japan Osaka)，a low-residue diet package for each meal. The duration of study is one day before colonoscopy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Cleansing Level at Colonoscopy by Ottawa Bowel Preparation Scale | Ottawa preparation scale: Colon is defined into 3 segments: Right(cecum, ascending), mid(transverse, descending), rectosigmoid. Each is scored from 0 to 4, 0 is best and 4 is worst. Fluid quantity of whole is scored as 0, small; 1, moderate; 2 large amount. The scale will be summation of the clearness of 3 segments of colon and overall fluid quantity. It ranged from 0 to 14, 0 is the most clean colon and 14 is the most dirty one. Segment score will be analyzed separately as continuous variable. | 1 day |
| Overall Cleansing Level at Colonoscopy by Aronchick Scale | The overall proportion of participants scored as Excellent or Good by Aronchick scale. Description of Aronchick scale:It categorized colon cleansing into 5 level: Excellent, good, fair, poor, inadequate. It is categorical and cannot be summed. We will present | 1 day |
| Total Volume of Purgatives That Ingested | The total volume of PEG-ELS (Liter) that ingested or could be ingested by examinee before colonoscopy | 1 day |
| Segmental Cleansing Level at Colonoscopy (Right Segment Preparation Failure) | Segmental score of Ottawa bowel preparation scale was analyzed. The proportion of "right segment" preparation failure, defined as segmental score as "3 poor" or "4 inadequate", was presented. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Willingness to Choose the Same Protocol After Different Low Residual Diet and PEG-ELS Protocol | It represent the proportion of participants who wanted to choose the same protocol as they received in this trial. | 1 day |
| Satisfaction of Different Low Residual Diet and Bowel Preparation Protocol |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Han-Mo Chiu, M.D., Ph.D. | NTUH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| E-Da Hospital | Kaohsiung | Taiwan | Taiwan | |||
| National Taiwan University Hospital Bei-Hu Branch |
Not provided
Recruitment period: 14 months Recruitment location: GI outpatient clinic
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Low-residue Diet Package and 2L PEG | Low-residue diet package (Enimaclin) with normal amount 2L PEG-ELS |
| FG001 | Self-controlled Diet and 2L PEG | Self-controlled diet with normal amount 2L PEG-ELS |
| FG002 | Low-residue Diet Package and 1.5L PEG-ELS | Low-residue diet package(Enimaclin) with low volume 1.5L PEG-ELS |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Low-residue Diet Package (Enimaclin®) and 2L PEG | Low-residue diet package with normal amount of 2L PEG-ELS |
| BG001 | Self-controlled Diet and 2L PEG | Self-controlled diet with normal amount of 2L PEG-ELS |
| 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 | Overall Cleansing Level at Colonoscopy by Ottawa Bowel Preparation Scale | Ottawa preparation scale: Colon is defined into 3 segments: Right(cecum, ascending), mid(transverse, descending), rectosigmoid. Each is scored from 0 to 4, 0 is best and 4 is worst. Fluid quantity of whole is scored as 0, small; 1, moderate; 2 large amount. The scale will be summation of the clearness of 3 segments of colon and overall fluid quantity. It ranged from 0 to 14, 0 is the most clean colon and 14 is the most dirty one. Segment score will be analyzed separately as continuous variable. | Posted | Mean | Standard Deviation | units on a scale | 1 day |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Low-residue Diet Package | Low-residue diet package (Enimaclin) with normal amount 2L PEG-ELS |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment | Mild abdominal pain noted after bowel preparation. |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Han-Mo Chiu, M.D., Ph.D. | National Taiwan University Hospital | hanmochiu@ntu.edu.tw |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Self-controlled diet | Other | Self-controlled low residue diet. |
|
|
| 2L PEG-ELS | Drug | Normal volume of PEG-ELS |
|
|
| low volume 1.5L PEG-ELS | Drug | Low volume PEG-ELS |
|
|
It represented the percentage of participants who is satisfied with the protocol. |
| 1 day |
| Convenience of Different Low Residual Diet and Bowel Preparation Protocol | It represented the percentage of participants who thinks the protocol is easy to use. | 1 day |
| Taipei |
| Taiwan |
| Taiwan |
| National Taiwan University Hospital | Taipei | Taiwan | Taiwan |
| Taipei Medical University Hospital | Taipei | Taiwan | Taiwan |
| BG002 | Low-residue Diet (Enimaclin®) Package and 1.5L PEG | Low-residue diet package with normal amount of 1.5L PEG-ELS |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Self-controlled diet with normal amount 2L PEG-ELS |
| OG002 | Low-residue Diet Package Plus 1.5L PEG | Low-residue diet package(Enimaclin) with low volume 1.5L PEG-ELS |
|
|
|
| Primary | Overall Cleansing Level at Colonoscopy by Aronchick Scale | The overall proportion of participants scored as Excellent or Good by Aronchick scale. Description of Aronchick scale:It categorized colon cleansing into 5 level: Excellent, good, fair, poor, inadequate. It is categorical and cannot be summed. We will present | Posted | Number | percentage of participants | 1 day |
|
|
|
|
| Secondary | Willingness to Choose the Same Protocol After Different Low Residual Diet and PEG-ELS Protocol | It represent the proportion of participants who wanted to choose the same protocol as they received in this trial. | Posted | Number | percentage of participants | 1 day |
|
|
|
| Primary | Total Volume of Purgatives That Ingested | The total volume of PEG-ELS (Liter) that ingested or could be ingested by examinee before colonoscopy | Posted | Mean | Standard Deviation | Liter | 1 day |
|
|
|
| Secondary | Satisfaction of Different Low Residual Diet and Bowel Preparation Protocol | It represented the percentage of participants who is satisfied with the protocol. | Posted | Number | Percentage of participants | 1 day |
|
|
|
|
| Secondary | Convenience of Different Low Residual Diet and Bowel Preparation Protocol | It represented the percentage of participants who thinks the protocol is easy to use. | Posted | Number | percentage of participants | 1 day |
|
|
|
|
| Primary | Segmental Cleansing Level at Colonoscopy (Right Segment Preparation Failure) | Segmental score of Ottawa bowel preparation scale was analyzed. The proportion of "right segment" preparation failure, defined as segmental score as "3 poor" or "4 inadequate", was presented. | Posted | Number | percentage of participants | 1 day |
|
|
|
|
| 0 |
| 60 |
| 0 |
| 60 |
| EG001 | Self-controlled Diet | Self-controlled diet with normal amount 2L PEG-ELS | 0 | 60 | 1 | 60 |
| EG002 | Low-residue Diet Package Plus 1.5L PEG-ELS | Low-residue diet package(Enimaclin) with low volume 1.5L PEG-ELS | 0 | 60 | 0 | 60 |
|
Not provided
Not provided
| 0.024 |
| No |
| Superiority or Other |
| Chi-squared | 0.041 | No | Superiority or Other |