Bowel Preparation
Conditions
Brief summary
To describe the feasibility and effectiveness of three dietary regimens in precolonoscopy bowel preparation in children
Detailed description
The accuracy of endoscopic diagnosis and treatment of safety depends largely on the intestinal cleaning quality. Qualified bowel preparation is a prerequisite for clear vision during colonoscopy. Presently, the common diet for children before colonoscopy in China is a liquid or low residual diet. The liquid and low residual diet often have poor taste and satiety, often resulting in poor compliance of children, especially young children, who are often unwilling to eat a liquid diet, resulting in insufficient caloric supply and unstable blood glucose during bowel preparation. Enteral formula as a kind of high-energy and low-fiber diet has been applied in clinical practice. Currently, there is no comparison between liquid diet, low-residue diet, and enteral formulas in children's bowel preparation in China. Dietary restriction is an indispensable part to ensure the success of the bowel preparation program. There is an urgent need to conduct research on the application of various dietary programs in children's bowel preparation before colonoscopy in China. In order to provide high-quality evidence for the bowel preparation diet program for children.
Interventions
DIETARY_SUPPLEMENTLow residual diet group
Low residua diet included gruel with grain only, peeled carrot, white gourd, powdered skin, tofu, vegetable, mud and fruit. were given to children for bowel preparation
DIETARY_SUPPLEMENTLiquid diet group
Fluid diet including juice, rice soup, filtered vegetable juice/broth, lotus root powder and milk and egg soup were given to children for bowel preparation.
DIETARY_SUPPLEMENTEnteral nutrition group
100% short peptide enteral nutrition are given to children for bowel preparation
Sponsors
Children's Hospital of Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 18 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age 2 years～18 years old 2. Children under anesthesia for elective colonoscopy with bowel preparation
Exclusion criteria
1. Children who are unable to perform bowel preparation with polyethylene glycol-4000 2. Children whose guardians refuse to participate in this study 3. Children who are unable to eat orally 4. Children with stomy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Boston Bowel Preparation Scale score | After the children finish their bowel preparation, an average of 5 minutes | The nurse will use the Boston Bowel Preparation Scale colonoscopic to evaluate the intestinal fecal trait under colonoscope and record in the case report form. The right side (cecum and ascending colon), transverse colon (hepatic flexion and splenic flexion) and left side (descending colon, sigmoid colon and rectum) were scored respectively. 0 score: a large amount of solid stool remains in the colon; 1 score: liquid and semi-solid feces exist in some intestinal segments; 2 points: a small amount of feces remains, but does not affect the colonoscopic field of view; 3 points: no solid liquid fecal residue in the colon. The total score of the scale is 9 points, 8-9 points is excellent; 6-7 points is good; 4-5 points is average; 0-3 points is Poor. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Revised-Bristol Stool Form Scale score | After the children finish their bowel preparation, an average of 5 minutes. | The fecal traits are recorded in the case report form by the nurse with a Revised-Bristol Stool Form Scale according to the stool characteristics of children. The score was 8 points in order: 8 points: clear water stool, no residue; 7 points: turbid water sample, with or without a small amount of fecal residue; 6 points: velvet, unclear edge, mushy stool; 5 points: soft mass, clear edge; 4 points: like sausage or snake, smooth and soft; 3 points: sausage-shaped, but with cracks on the surface; 2 points: sausage-shaped, but in chunks; 1 point: scattered hard pieces, like nuts. A score of 8 indicates that the naked eye assessment of bowel preparation is qualified, and colonoscopy can be performed directly. A score of 6-7 indicates that bowel preparation is not sufficient, and a colonoscopy should be performed at the selected day. ≤5 points is recommended to cancel the colonoscopy on the same day and extend the bowel preparation time. |
| The times of enema | After the children finish their enema, an average of 1 minute. | Children with substandard bowel preparation before colonoscopy were going to undergo enemas to ensure the visual clarity of colonoscopy. The times of enema will be recorded by the nurse who perform the enema in the case report form. |
| Number of defecation during bowel preparation | After the children finish their bowel preparation, an average of 1 minute. | The number of defecation during bowel preparation will be recorded in the case report form by the nurse. |
| Medication compliance | After the children finish their bowel preparation, an average of 3 minutes. | Children who complete less than 30% polyethylene glycol 4000 (PEG-4000) are defined as having poor compliance, completing 30%\ 60% PEG-4000 is fair compliance, completing 60%\ 80% PEG-4000 is good compliance, and great than 80% PEG-4000 is excellent compliance. The nurse will evaluate children's compliance according to their completion of PEG-4000 and record it in the case report form. |
| Adverse reactions of bowel preparation | During children's bowel preparation, an average of 24 hours. | Acceptable safety indicators: occasional and mild nausea, vomiting, abdominal pain, abdominal distension; a few sporadic rashes; perianal discomfort. Indicators need to be closely monitored: frequent and severe vomiting, abdominal pain, abdominal distension, blood in the stool; Widespread or diffuse rash. Unacceptable indicators: fecal incontinence, dehydration, and electrolyte disturbance; intestinal perforation; shock. All the adverse reactions will be observed and recorded in the case report form by the nurse. |
Countries
China
Outcome results
None listed