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Efficacy and Acceptability of Low-Residue Diet Package (Enimaclin®) as Diet Control Before Colonoscopy

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ClinicalTrials.gov Identifier: NCT01665157
Recruitment Status : Completed
First Posted : August 15, 2012
Results First Posted : February 6, 2014
Last Update Posted : April 2, 2014
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator)
Condition Dietary Modification
Interventions Dietary Supplement: Enimaclin®
Other: Self-controlled diet
Drug: 2L PEG-ELS
Drug: low volume 1.5L PEG-ELS
Enrollment 180
Recruitment Details Recruitment period: 14 months Recruitment location: GI outpatient clinic
Pre-assignment Details  
Arm/Group Title Low-residue Diet Package and 2L PEG Self-controlled Diet and 2L PEG Low-residue Diet Package and 1.5L PEG-ELS
Hide Arm/Group Description Low-residue diet package (Enimaclin) with normal amount 2L PEG-ELS Self-controlled diet with normal amount 2L PEG-ELS Low-residue diet package(Enimaclin) with low volume 1.5L PEG-ELS
Period Title: Overall Study
Started 60 60 60
Completed 60 60 60
Not Completed 0 0 0
Arm/Group Title Low-residue Diet Package (Enimaclin®) and 2L PEG Self-controlled Diet and 2L PEG Low-residue Diet (Enimaclin®) Package and 1.5L PEG Total
Hide Arm/Group Description Low-residue diet package with normal amount of 2L PEG-ELS Self-controlled diet with normal amount of 2L PEG-ELS Low-residue diet package with normal amount of 1.5L PEG-ELS Total of all reporting groups
Overall Number of Baseline Participants 60 60 60 180
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 60 participants 180 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
54
  90.0%
49
  81.7%
54
  90.0%
157
  87.2%
>=65 years
6
  10.0%
11
  18.3%
6
  10.0%
23
  12.8%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 60 participants 60 participants 60 participants 180 participants
52.5  (10.6) 51.3  (12.7) 53.0  (11.0) 52.3  (11.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 60 participants 180 participants
Female
28
  46.7%
29
  48.3%
24
  40.0%
81
  45.0%
Male
32
  53.3%
31
  51.7%
36
  60.0%
99
  55.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Taiwan Number Analyzed 60 participants 60 participants 60 participants 180 participants
60 60 60 180
1.Primary Outcome
Title Overall Cleansing Level at Colonoscopy by Ottawa Bowel Preparation Scale
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low-residue Diet Package and 2L PEG Self-controlled Diet and 2L PEG Low-residue Diet Package Plus 1.5L PEG
Hide Arm/Group Description:
Low-residue diet package (Enimaclin) with normal amount 2L PEG-ELS
Self-controlled diet with normal amount 2L PEG-ELS
Low-residue diet package(Enimaclin) with low volume 1.5L PEG-ELS
Overall Number of Participants Analyzed 60 60 60
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.58  (2.15) 3.22  (3.08) 2.97  (2.79)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Low-residue Diet Package and 2L PEG, Self-controlled Diet and 2L PEG, Low-residue Diet Package Plus 1.5L PEG
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.435
Comments Not significant
Method ANOVA
Comments [Not Specified]
2.Primary Outcome
Title Overall Cleansing Level at Colonoscopy by Aronchick Scale
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low-residue Diet Package and 2L PEG Self-controlled Diet and 2L PEG Low-residue Diet Package Plus 1.5L PEG-ELS
Hide Arm/Group Description:
Low-residue diet package (Enimaclin) with normal amount 2L PEG-ELS
Self-controlled diet with normal amount 2L PEG-ELS
Low-residue diet package(Enimaclin) with reduced volume low volume 1.5L PEG-ELS
Overall Number of Participants Analyzed 60 60 60
Measure Type: Number
Unit of Measure: percentage of participants
91.7 76.7 78.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Low-residue Diet Package and 2L PEG, Self-controlled Diet and 2L PEG, Low-residue Diet Package Plus 1.5L PEG-ELS
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.046
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Low-residue Diet Package and 2L PEG, Self-controlled Diet and 2L PEG
Comments Null hypothesis: "Low-residue diet package and 2L PEG" vs. "Self-controlled diet and 2L PEG" provides same preparation quality.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.024
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Low-residue Diet Package and 2L PEG, Low-residue Diet Package Plus 1.5L PEG-ELS
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.041
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
3.Primary Outcome
Title Total Volume of Purgatives That Ingested
Hide Description The total volume of PEG-ELS (Liter) that ingested or could be ingested by examinee before colonoscopy
Time Frame 1 day
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low-residue Diet Package and 2L PEG Self-controlled Diet and 2L PEG Low-residue Diet Package and 1.5L PEG
Hide Arm/Group Description:
Low-residue diet package (Enimaclin) with normal amount 2L PEG-ELS
Self-controlled diet with normal amount 2L PEG-ELS
Low-residue diet package(Enimaclin) with low volume 1.5L PEG-ELS
Overall Number of Participants Analyzed 60 60 60
Mean (Standard Deviation)
Unit of Measure: Liter
1.96  (0.16) 1.98  (0.12) 1.61  (0.27)
4.Primary Outcome
Title Segmental Cleansing Level at Colonoscopy (Right Segment Preparation Failure)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low-residue Diet Package and 2L PEG Self-controlled Diet and 2L PEG Low-residue Diet Package Plus 1.5L PEG
Hide Arm/Group Description:
Low-residue diet package (Enimaclin) with normal amount 2L PEG-ELS
Self-controlled diet with normal amount 2L PEG-ELS
Low-residue diet package(Enimaclin) with low volume 1.5L PEG-ELS
Overall Number of Participants Analyzed 60 60 60
Measure Type: Number
Unit of Measure: percentage of participants
1.7 15.0 6.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Low-residue Diet Package and 2L PEG, Self-controlled Diet and 2L PEG, Low-residue Diet Package Plus 1.5L PEG
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.025
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
5.Secondary Outcome
Title Willingness to Choose the Same Protocol After Different Low Residual Diet and PEG-ELS Protocol
Hide Description It represent the proportion of participants who wanted to choose the same protocol as they received in this trial.
Time Frame 1 day
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low-residue Diet Package and 2L PEG Self-controlled Diet and 2L PEG Low-residue Diet Package and 1.5L PEG
Hide Arm/Group Description:
Low-residue diet package (Enimaclin) with normal amount 2L PEG-ELS
Self-controlled diet with normal amount 2L PEG-ELS
Low-residue diet package(Enimaclin) with low volume 1.5L PEG-ELS
Overall Number of Participants Analyzed 60 60 60
Measure Type: Number
Unit of Measure: percentage of participants
93.3 90.0 95.0
6.Secondary Outcome
Title Satisfaction of Different Low Residual Diet and Bowel Preparation Protocol
Hide Description It represented the percentage of participants who is satisfied with the protocol.
Time Frame 1 day
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low-residue Diet Package and 2L PEG Self-controlled Diet and 2L PEG Low-residue Diet Package and 1.5 L PEG-ELS
Hide Arm/Group Description:
Low-residue diet package (Enimaclin) with normal amount 2L PEG-ELS
Self-controlled diet with normal amount 2L PEG-ELS
Low-residue diet package(Enimaclin) with low volume 1.5L PEG-ELS
Overall Number of Participants Analyzed 60 60 60
Measure Type: Number
Unit of Measure: Percentage of participants
73.3 36.7 76.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Low-residue Diet Package and 2L PEG, Self-controlled Diet and 2L PEG, Low-residue Diet Package and 1.5 L PEG-ELS
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
7.Secondary Outcome
Title Convenience of Different Low Residual Diet and Bowel Preparation Protocol
Hide Description It represented the percentage of participants who thinks the protocol is easy to use.
Time Frame 1 day
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low-residue Diet Package and 2L PEG Self-controlled Diet and 2L PEG Low-residue Diet Package and 1.5L PEG
Hide Arm/Group Description:
Low-residue diet package (Enimaclin) with normal amount 2L PEG-ELS
Self-controlled diet with 2L PEG-ELS
Low-residue diet package(Enimaclin) with reduced volume 1.5L PEG-ELS
Overall Number of Participants Analyzed 60 60 60
Measure Type: Number
Unit of Measure: percentage of participants
88.3 76.7 93.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Low-residue Diet Package and 2L PEG, Self-controlled Diet and 2L PEG, Low-residue Diet Package and 1.5L PEG
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Low-residue Diet Package Self-controlled Diet Low-residue Diet Package Plus 1.5L PEG-ELS
Hide Arm/Group Description Low-residue diet package (Enimaclin) with normal amount 2L PEG-ELS Self-controlled diet with normal amount 2L PEG-ELS Low-residue diet package(Enimaclin) with low volume 1.5L PEG-ELS
All-Cause Mortality
Low-residue Diet Package Self-controlled Diet Low-residue Diet Package Plus 1.5L PEG-ELS
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Low-residue Diet Package Self-controlled Diet Low-residue Diet Package Plus 1.5L PEG-ELS
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/60 (0.00%)      0/60 (0.00%)      0/60 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Low-residue Diet Package Self-controlled Diet Low-residue Diet Package Plus 1.5L PEG-ELS
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/60 (0.00%)      1/60 (1.67%)      0/60 (0.00%)    
Gastrointestinal disorders       
Abdominal pain  [1]  0/60 (0.00%)  0 1/60 (1.67%)  1 0/60 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Mild abdominal pain noted after bowel preparation.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Han-Mo Chiu, M.D., Ph.D.
Organization: National Taiwan University Hospital
Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01665157     History of Changes
Other Study ID Numbers: NTUH201109018RD
First Submitted: February 27, 2012
First Posted: August 15, 2012
Results First Submitted: February 21, 2013
Results First Posted: February 6, 2014
Last Update Posted: April 2, 2014