Comparison of Two Bowel Cleansing Regimens（Controlled Dietary Restriction With Enteral Nutrition and 1.5L Polyethylene Glycol vs Controlled Dietary Restriction and 2.0L Polyethylene Glycol）：an Endoscopist-blinded, Prospective Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Enteral Nutrition Powder Ensure
- Conditions
- Bowel Preparation
- Sponsor
- Ningbo No. 1 Hospital
- Enrollment
- 248
- Locations
- 1
- Primary Endpoint
- the quality of bowel preparation
- Last Updated
- 6 years ago
Overview
Brief Summary
This clinical trial is being conducted to assess whether dietary restriction with enteral nutrition prescribed could prevent nonadherence to dietary restrictions, enable additional reduction of the required volume of PEG-ELS.
Detailed Description
Bowel preparation plays a vital role in the quality of colonoscopy.Bowel preparation consists of 2 key steps: dietary restriction and purgative ingestion.Two liters of PEG-ELS are widely used in Asian countries, but in a well-designed clinical trial，additional reduction of PEG-ELS volume seems feasible. Enteral nutrition may simplify the process and avoid unexpected intake of fiber-containing food. We hypothesized that dietary restriction with enteral nutrition prescribed could prevent nonadherence to dietary restrictions, enable additional reduction of the required volume of PEG-ELS.
Investigators
Eligibility Criteria
Inclusion Criteria
- •the age of 18-75year
- •Outpatients undergoing colonoscopy
- •Informed consent
Exclusion Criteria
- •the age \>75 years or \<18 years
- •history of colectomy or bowel obstruction
- •severe constipation (defined as stool frequerncy of 3 or less/week)
- •current pregnancy or breastfeeding
- •BMI \>30, diabetes
- •known allergies to cleansing agents or ingredients of Enteral nutrition
- •inability to follow the oral bowel preparation regimen.
Arms & Interventions
Enteral Nutritional+PEG
Enteral Nutritional Powder with low volume 1.5L PEG
Intervention: Enteral Nutrition Powder Ensure
Enteral Nutritional+PEG
Enteral Nutritional Powder with low volume 1.5L PEG
Intervention: 1.5L PEG
Self-controlled diet+PEG
Self-controlled diet with normal amount of 2L PEG
Intervention: Self-controlled diet
Self-controlled diet+PEG
Self-controlled diet with normal amount of 2L PEG
Intervention: 2L PEG
Outcomes
Primary Outcomes
the quality of bowel preparation
Time Frame: 1day
Evaluation of the quality of bowel preparation for each participant by the Ottawa bowel preparation scale(OBPS)，it's a validated scoring system with scores between 0 and 14, where 0 is the best score，The score comprises a sub score 0-4 for each colon segment: right, transverse and rectosigmoid colon.n addition, a score 0-2 is added to indicate the total amount of luminal fluid.
Secondary Outcomes
- adverse events(1day)
- patients' satisfaction with the process of bowel preparation(1day)
- Convenience of Protocol between enteral nutrition with low volume 1.5L PEG and Self-controlled diet with normal amount of 2L PEG Protocol(1day)
- patients' willingness to have the colonoscopy done again at this facility in the future(1day)
- comparison with previous experience(1day)