Bowel Preparation
Conditions
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.
Interventions
DIETARY_SUPPLEMENTEnteral Nutrition Powder Ensure
Enteral Nutrition Powder Ensure for each meal.The duration of study is one day before colonoscopy.
DRUG1.5L PEG
Low volume PEG
OTHERSelf-controlled diet
Self-controlled low residue diet.
DRUG2L PEG
Normal volume of PEG
Sponsors
Ningbo No. 1 Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
1. the age of 18-75year 2. Outpatients undergoing colonoscopy 3. Informed consent
Exclusion criteria
1. the age \>75 years or \<18 years 2. history of colectomy or bowel obstruction 3. severe constipation (defined as stool frequerncy of 3 or less/week) 4. current pregnancy or breastfeeding 5. BMI \>30, diabetes 6. known allergies to cleansing agents or ingredients of Enteral nutrition 7. inability to follow the oral bowel preparation regimen.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the quality of bowel preparation | 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
| Measure | Time frame | Description |
|---|---|---|
| Convenience of Protocol between enteral nutrition with low volume 1.5L PEG and Self-controlled diet with normal amount of 2L PEG Protocol | 1day | It represented the percentage of patients who thinks the protocol is easy to use. |
| patients' satisfaction with the process of bowel preparation | 1day | At the end of the procedure, the patients were asked about the satisfaction with the process of bowel preparation. Satisfaction includes bad，not so bad and good.Bad means that the patient is not satisfied with the program, not so bad means that the patient is satisfied with the plan, and good means that the patient is very satisfied with the plan. |
| patients' willingness to have the colonoscopy done again at this facility in the future | 1day | It represent participants who wanted to choose the same protocol in the future as they received in this trial.Including yes and no two options, if yes, indicating that the patient is willing to undergo colonoscopy again, if no, indicating that the patient is reluctant to undergo colonoscopy again. |
| comparison with previous experience | 1day | If patients with colonoscopy times ≥ 2, they need to compare with previous experience，Including better than last experience, similar to the last experience, and worse than the last experience. |
| adverse events | 1day | It represent the incidence of abdominal cramping, bloating, nausea/vomiting after intake of PEG and/or enteral nutrition was compared. |
Countries
China
Contacts
Primary ContactLei Xu, PhD
Backup ContactHongpeng Lu, master
Outcome results
None listed