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Completed

NCT Number: NCT05609591

Three Dietary Regimens in Pre-colonoscopic Bowel Preparation in Children

To describe the feasibility and effectiveness of three dietary regimens in precolonoscopy bowel preparation in children

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Key information

Conditions

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children'S Hospital of Fudan University

Shanghai, Shanghai Municipality, 201100, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 2 years~18 years old
  • Children under anesthesia for elective colonoscopy with bowel preparation

Exclusion criteria

  • Children who are unable to perform bowel preparation with polyethylene glycol-4000
  • Children whose guardians refuse to participate in this study
  • Children who are unable to eat orally
  • Children with stomy

Treatment and study plan

Liquid diet group

Dietary Supplement

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.

Enteral nutrition group

Dietary Supplement

100% short peptide enteral nutrition are given to children for bowel preparation

Low residual diet group

Dietary Supplement

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

Primary outcomes

  1. Boston Bowel Preparation Scale score

    Time frame: 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 outcomes

  1. Revised-Bristol Stool Form Scale score

    Time frame: 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.

  2. The times of enema

    Time frame: 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.

  3. Number of defecation during bowel preparation

    Time frame: 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.

  4. Medication compliance

    Time frame: 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.

  5. Adverse reactions of bowel preparation

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Registry information

Official study title

Three Dietary Regimens in Pre-colonoscopic Bowel Preparation in Children : A Randomized Clinical Trial

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Nov 8, 2022
Registry last updated
Oct 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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