Dietary Modification
Conditions
Keywords
Diet Control before Colonoscopy
Brief summary
The purpose of this study is to evaluate the efficacy and the acceptability of low-residue diet package (Enimaclin®) as diet control before colonoscopy.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTEnimaclin®
Enimaclin Colomil ® (Glico Co., Japan Osaka)，a low-residue diet package for each meal. The duration of study is one day before colonoscopy.
OTHERSelf-controlled diet
Self-controlled low residue diet.
DRUG2L PEG-ELS
Normal volume of PEG-ELS
DRUGlow volume 1.5L PEG-ELS
Low volume PEG-ELS
Sponsors
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Male or female * Outpatient or healthy volunteer for health examination, 20\ 75 years old * Eligible for oral bowel preparation * BMI (Body Mass Index) ≤ 30
Exclusion criteria
* Patients with severe constipation (as fewer than three stools per week) * Patients with bowel obstruction * Patients contraindicated with treatment drug * Patients who need emergency medication * Ineligible for bowel preparation * Pregnant or breast-feeding * Patients with known allergies to treatment drug or low-residue diet package * Patients who are ineligible to enroll
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Volume of Purgatives That Ingested | 1 day | The total volume of PEG-ELS (Liter) that ingested or could be ingested by examinee before colonoscopy |
| Segmental Cleansing Level at Colonoscopy (Right Segment Preparation Failure) | 1 day | 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. |
| Overall Cleansing Level at Colonoscopy by Aronchick Scale | 1 day | 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 |
| Overall Cleansing Level at Colonoscopy by Ottawa Bowel Preparation Scale | 1 day | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction of Different Low Residual Diet and Bowel Preparation Protocol | 1 day | It represented the percentage of participants who is satisfied with the protocol. |
| Convenience of Different Low Residual Diet and Bowel Preparation Protocol | 1 day | It represented the percentage of participants who thinks the protocol is easy to use. |
| Willingness to Choose the Same Protocol After Different Low Residual Diet and PEG-ELS Protocol | 1 day | It represent the proportion of participants who wanted to choose the same protocol as they received in this trial. |
Countries
Taiwan
Participant flow
Recruitment details
Recruitment period: 14 months Recruitment location: GI outpatient clinic
Participants by arm
| Arm | Count |
|---|---|
| Low-residue Diet Package (Enimaclin®) and 2L PEG Low-residue diet package with normal amount of 2L PEG-ELS | 60 |
| Self-controlled Diet and 2L PEG Self-controlled diet with normal amount of 2L PEG-ELS | 60 |
| Low-residue Diet (Enimaclin®) Package and 1.5L PEG Low-residue diet package with normal amount of 1.5L PEG-ELS | 60 |
| Total | 180 |
Baseline characteristics
| Characteristic | Self-controlled Diet and 2L PEG | Low-residue Diet (Enimaclin®) Package and 1.5L PEG | Low-residue Diet Package (Enimaclin®) and 2L PEG | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 11 Participants | 6 Participants | 6 Participants | 23 Participants |
| Age, Categorical Between 18 and 65 years | 49 Participants | 54 Participants | 54 Participants | 157 Participants |
| Age, Continuous | 51.3 years STANDARD_DEVIATION 12.7 | 53.0 years STANDARD_DEVIATION 11 | 52.5 years STANDARD_DEVIATION 10.6 | 52.3 years STANDARD_DEVIATION 11.4 |
| Region of Enrollment Taiwan | 60 participants | 60 participants | 60 participants | 180 participants |
| Sex: Female, Male Female | 29 Participants | 24 Participants | 28 Participants | 81 Participants |
| Sex: Female, Male Male | 31 Participants | 36 Participants | 32 Participants | 99 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 60 | 1 / 60 | 0 / 60 |
| serious Total, serious adverse events | 0 / 60 | 0 / 60 | 0 / 60 |
Outcome results
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
Time frame: 1 day
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Low-residue Diet Package and 2L PEG | Overall Cleansing Level at Colonoscopy by Aronchick Scale | 91.7 percentage of participants |
| Self-controlled Diet and 2L PEG | Overall Cleansing Level at Colonoscopy by Aronchick Scale | 76.7 percentage of participants |
| Low-residue Diet Package Plus 1.5L PEG | Overall Cleansing Level at Colonoscopy by Aronchick Scale | 78.3 percentage of participants |
p-value: 0.046Chi-squared
Comparison: Null hypothesis: Low-residue diet package and 2L PEG vs. Self-controlled diet and 2L PEG provides same preparation quality.p-value: 0.024Chi-squared
p-value: 0.041Chi-squared
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.
Time frame: 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low-residue Diet Package and 2L PEG | Overall Cleansing Level at Colonoscopy by Ottawa Bowel Preparation Scale | 2.58 units on a scale | Standard Deviation 2.15 |
| Self-controlled Diet and 2L PEG | Overall Cleansing Level at Colonoscopy by Ottawa Bowel Preparation Scale | 3.22 units on a scale | Standard Deviation 3.08 |
| Low-residue Diet Package Plus 1.5L PEG | Overall Cleansing Level at Colonoscopy by Ottawa Bowel Preparation Scale | 2.97 units on a scale | Standard Deviation 2.79 |
p-value: 0.435ANOVA
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.
Time frame: 1 day
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Low-residue Diet Package and 2L PEG | Segmental Cleansing Level at Colonoscopy (Right Segment Preparation Failure) | 1.7 percentage of participants |
| Self-controlled Diet and 2L PEG | Segmental Cleansing Level at Colonoscopy (Right Segment Preparation Failure) | 15.0 percentage of participants |
| Low-residue Diet Package Plus 1.5L PEG | Segmental Cleansing Level at Colonoscopy (Right Segment Preparation Failure) | 6.7 percentage of participants |
p-value: 0.025Chi-squared
Primary
Total Volume of Purgatives That Ingested
The total volume of PEG-ELS (Liter) that ingested or could be ingested by examinee before colonoscopy
Time frame: 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low-residue Diet Package and 2L PEG | Total Volume of Purgatives That Ingested | 1.96 Liter | Standard Deviation 0.16 |
| Self-controlled Diet and 2L PEG | Total Volume of Purgatives That Ingested | 1.98 Liter | Standard Deviation 0.12 |
| Low-residue Diet Package Plus 1.5L PEG | Total Volume of Purgatives That Ingested | 1.61 Liter | Standard Deviation 0.27 |
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.
Time frame: 1 day
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Low-residue Diet Package and 2L PEG | Convenience of Different Low Residual Diet and Bowel Preparation Protocol | 88.3 percentage of participants |
| Self-controlled Diet and 2L PEG | Convenience of Different Low Residual Diet and Bowel Preparation Protocol | 76.7 percentage of participants |
| Low-residue Diet Package Plus 1.5L PEG | Convenience of Different Low Residual Diet and Bowel Preparation Protocol | 93.3 percentage of participants |
p-value: <0.01Chi-squared
Secondary
Satisfaction of Different Low Residual Diet and Bowel Preparation Protocol
It represented the percentage of participants who is satisfied with the protocol.
Time frame: 1 day
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Low-residue Diet Package and 2L PEG | Satisfaction of Different Low Residual Diet and Bowel Preparation Protocol | 73.3 Percentage of participants |
| Self-controlled Diet and 2L PEG | Satisfaction of Different Low Residual Diet and Bowel Preparation Protocol | 36.7 Percentage of participants |
| Low-residue Diet Package Plus 1.5L PEG | Satisfaction of Different Low Residual Diet and Bowel Preparation Protocol | 76.7 Percentage of participants |
p-value: <0.01Chi-squared
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.
Time frame: 1 day
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Low-residue Diet Package and 2L PEG | Willingness to Choose the Same Protocol After Different Low Residual Diet and PEG-ELS Protocol | 93.3 percentage of participants |
| Self-controlled Diet and 2L PEG | Willingness to Choose the Same Protocol After Different Low Residual Diet and PEG-ELS Protocol | 90.0 percentage of participants |
| Low-residue Diet Package Plus 1.5L PEG | Willingness to Choose the Same Protocol After Different Low Residual Diet and PEG-ELS Protocol | 95.0 percentage of participants |