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

National Taiwan University Hospital180 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

SINGLE

Enrollment

180

Conditions

Dietary Modification

Interventions

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.

Self-controlled dietOTHER

Self-controlled low residue diet.

2L PEG-ELSDRUG

Normal volume of PEG-ELS

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (4)

E-Da Hospital

Kaohsiung, Taiwan, Taiwan

National Taiwan University Hospital Bei-Hu Branch

Taipei, Taiwan, Taiwan

National Taiwan University Hospital

Taipei, Taiwan, Taiwan

Taipei Medical University Hospital

Taipei, Taiwan, Taiwan

Outcomes

Primary Outcomes

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

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

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

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

Secondary Outcomes

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

Satisfaction of Different Low Residual Diet and Bowel Preparation Protocol

Data from ClinicalTrials.gov

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