Trial Outcomes & Findings for Efficacy and Acceptability of Low-Residue Diet Package (Enimaclin®) as Diet Control Before Colonoscopy (NCT NCT01665157)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

180 participants

Primary outcome timeframe

1 day

Results posted on

2014-04-02

Participant Flow

Recruitment period: 14 months Recruitment location: GI outpatient clinic

Participant milestones

Participant milestones
Measure	Low-residue Diet Package and 2L PEG Low-residue diet package (Enimaclin) with normal amount 2L PEG-ELS	Self-controlled Diet and 2L PEG Self-controlled diet with normal amount 2L PEG-ELS	Low-residue Diet Package and 1.5L PEG-ELS Low-residue diet package(Enimaclin) with low volume 1.5L PEG-ELS
Overall Study STARTED	60	60	60
Overall Study COMPLETED	60	60	60
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Low-residue Diet Package (Enimaclin®) and 2L PEG n=60 Participants Low-residue diet package with normal amount of 2L PEG-ELS	Self-controlled Diet and 2L PEG n=60 Participants Self-controlled diet with normal amount of 2L PEG-ELS	Low-residue Diet (Enimaclin®) Package and 1.5L PEG n=60 Participants Low-residue diet package with normal amount of 1.5L PEG-ELS	Total n=180 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	54 Participants n=5 Participants	49 Participants n=7 Participants	54 Participants n=5 Participants	157 Participants n=4 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants	11 Participants n=7 Participants	6 Participants n=5 Participants	23 Participants n=4 Participants
Age, Continuous	52.5 years STANDARD_DEVIATION 10.6 • n=5 Participants	51.3 years STANDARD_DEVIATION 12.7 • n=7 Participants	53.0 years STANDARD_DEVIATION 11.0 • n=5 Participants	52.3 years STANDARD_DEVIATION 11.4 • n=4 Participants
Sex: Female, Male Female	28 Participants n=5 Participants	29 Participants n=7 Participants	24 Participants n=5 Participants	81 Participants n=4 Participants
Sex: Female, Male Male	32 Participants n=5 Participants	31 Participants n=7 Participants	36 Participants n=5 Participants	99 Participants n=4 Participants
Region of Enrollment Taiwan	60 participants n=5 Participants	60 participants n=7 Participants	60 participants n=5 Participants	180 participants n=4 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Low-residue Diet Package and 2L PEG n=60 Participants Low-residue diet package (Enimaclin) with normal amount 2L PEG-ELS	Self-controlled Diet and 2L PEG n=60 Participants Self-controlled diet with normal amount 2L PEG-ELS	Low-residue Diet Package Plus 1.5L PEG n=60 Participants Low-residue diet package(Enimaclin) with low volume 1.5L PEG-ELS
Overall Cleansing Level at Colonoscopy by Ottawa Bowel Preparation Scale	2.58 units on a scale Standard Deviation 2.15	3.22 units on a scale Standard Deviation 3.08	2.97 units on a scale Standard Deviation 2.79

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Low-residue Diet Package and 2L PEG n=60 Participants Low-residue diet package (Enimaclin) with normal amount 2L PEG-ELS	Self-controlled Diet and 2L PEG n=60 Participants Self-controlled diet with normal amount 2L PEG-ELS	Low-residue Diet Package Plus 1.5L PEG n=60 Participants Low-residue diet package(Enimaclin) with low volume 1.5L PEG-ELS
Overall Cleansing Level at Colonoscopy by Aronchick Scale	91.7 percentage of participants	76.7 percentage of participants	78.3 percentage of participants

PRIMARY outcome

Timeframe: 1 day

The total volume of PEG-ELS (Liter) that ingested or could be ingested by examinee before colonoscopy

Outcome measures

Outcome measures
Measure	Low-residue Diet Package and 2L PEG n=60 Participants Low-residue diet package (Enimaclin) with normal amount 2L PEG-ELS	Self-controlled Diet and 2L PEG n=60 Participants Self-controlled diet with normal amount 2L PEG-ELS	Low-residue Diet Package Plus 1.5L PEG n=60 Participants Low-residue diet package(Enimaclin) with low volume 1.5L PEG-ELS
Total Volume of Purgatives That Ingested	1.96 Liter Standard Deviation 0.16	1.98 Liter Standard Deviation 0.12	1.61 Liter Standard Deviation 0.27

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Low-residue Diet Package and 2L PEG n=60 Participants Low-residue diet package (Enimaclin) with normal amount 2L PEG-ELS	Self-controlled Diet and 2L PEG n=60 Participants Self-controlled diet with normal amount 2L PEG-ELS	Low-residue Diet Package Plus 1.5L PEG n=60 Participants Low-residue diet package(Enimaclin) with low volume 1.5L PEG-ELS
Segmental Cleansing Level at Colonoscopy (Right Segment Preparation Failure)	1.7 percentage of participants	15.0 percentage of participants	6.7 percentage of participants

SECONDARY outcome

Timeframe: 1 day

It represent the proportion of participants who wanted to choose the same protocol as they received in this trial.

Outcome measures

Outcome measures
Measure	Low-residue Diet Package and 2L PEG n=60 Participants Low-residue diet package (Enimaclin) with normal amount 2L PEG-ELS	Self-controlled Diet and 2L PEG n=60 Participants Self-controlled diet with normal amount 2L PEG-ELS	Low-residue Diet Package Plus 1.5L PEG n=60 Participants Low-residue diet package(Enimaclin) with low volume 1.5L PEG-ELS
Willingness to Choose the Same Protocol After Different Low Residual Diet and PEG-ELS Protocol	93.3 percentage of participants	90.0 percentage of participants	95.0 percentage of participants

SECONDARY outcome

Timeframe: 1 day

It represented the percentage of participants who is satisfied with the protocol.

Outcome measures

Outcome measures
Measure	Low-residue Diet Package and 2L PEG n=60 Participants Low-residue diet package (Enimaclin) with normal amount 2L PEG-ELS	Self-controlled Diet and 2L PEG n=60 Participants Self-controlled diet with normal amount 2L PEG-ELS	Low-residue Diet Package Plus 1.5L PEG n=60 Participants Low-residue diet package(Enimaclin) with low volume 1.5L PEG-ELS
Satisfaction of Different Low Residual Diet and Bowel Preparation Protocol	73.3 Percentage of participants	36.7 Percentage of participants	76.7 Percentage of participants

SECONDARY outcome

Timeframe: 1 day

It represented the percentage of participants who thinks the protocol is easy to use.

Outcome measures

Outcome measures
Measure	Low-residue Diet Package and 2L PEG n=60 Participants Low-residue diet package (Enimaclin) with normal amount 2L PEG-ELS	Self-controlled Diet and 2L PEG n=60 Participants Self-controlled diet with normal amount 2L PEG-ELS	Low-residue Diet Package Plus 1.5L PEG n=60 Participants Low-residue diet package(Enimaclin) with low volume 1.5L PEG-ELS
Convenience of Different Low Residual Diet and Bowel Preparation Protocol	88.3 percentage of participants	76.7 percentage of participants	93.3 percentage of participants

Adverse Events

Low-residue Diet Package

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Self-controlled Diet

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Low-residue Diet Package Plus 1.5L PEG-ELS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Low-residue Diet Package n=60 participants at risk Low-residue diet package (Enimaclin) with normal amount 2L PEG-ELS	Self-controlled Diet n=60 participants at risk Self-controlled diet with normal amount 2L PEG-ELS	Low-residue Diet Package Plus 1.5L PEG-ELS n=60 participants at risk Low-residue diet package(Enimaclin) with low volume 1.5L PEG-ELS
Gastrointestinal disorders Abdominal pain	0.00% 0/60	1.7% 1/60 • Number of events 1	0.00% 0/60

Additional Information

Han-Mo Chiu, M.D., Ph.D.

National Taiwan University Hospital

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place