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

Not Applicable

Completed

• Conditions: Dietary Modification
• Interventions: Dietary Supplement: Enimaclin®; Other: Self-controlled diet; Drug: 2L PEG-ELS; Drug: low volume 1.5L PEG-ELS

• Registration Number: NCT01665157
• Lead Sponsor: National Taiwan University Hospital

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.

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2012-02-27
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Study First Submitted QC: 2012-08-13
• Study First Posted: 2012-08-15
• Results First Submitted: 2013-02-21
• Results First Submitted QC: 2013-12-17
• Status Verified: 2014-02
• Results First Posted: 2014-02-06
• Last Update Submitted: 2014-02-18
• Last Update Posted: 2014-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Self-controlled diet	2L PEG-ELS	Self-controlled diet with normal amount of 2L PEG-ELS
Low-residue diet (Enimaclin®) package	Enimaclin®	Low-residue diet package with low volume 1.5L PEG-ELS
Low-residue diet (Enimaclin®) package	low volume 1.5L PEG-ELS	Low-residue diet package with low volume 1.5L PEG-ELS
low-residue diet package (Enimaclin®)	Enimaclin®	Low-residue diet package with normal amount 2L PEG-ELS
low-residue diet package (Enimaclin®)	2L PEG-ELS	Low-residue diet package with normal amount 2L PEG-ELS
Self-controlled diet	Self-controlled diet	Self-controlled diet with normal amount of 2L PEG-ELS

Primary Outcome Measures

Name	Time	Method
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.
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
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.

Secondary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (4)

E-Da Hospital; 🇨🇳 Kaohsiung, Taiwan

National Taiwan University Hospital Bei-Hu Branch; 🇨🇳 Taipei, Taiwan

Taipei Medical University Hospital; 🇨🇳 Taipei, Taiwan

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan