Bowel Preparation Clinical Trial
Official title:
Three Dietary Regimens in Pre-colonoscopic Bowel Preparation in Children : A Randomized Clinical Trial
To describe the feasibility and effectiveness of three dietary regimens in precolonoscopy bowel preparation in children
Status | Recruiting |
Enrollment | 900 |
Est. completion date | June 30, 2024 |
Est. primary completion date | October 1, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 2 Years to 18 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
China | Children'S Hospital of Fudan University | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital of Fudan University |
China,
Barkun A, Chiba N, Enns R, Marcon M, Natsheh S, Pham C, Sadowski D, Vanner S. Commonly used preparations for colonoscopy: efficacy, tolerability, and safety--a Canadian Association of Gastroenterology position paper. Can J Gastroenterol. 2006 Nov;20(11):6 — View Citation
Belsey J, Epstein O, Heresbach D. Systematic review: oral bowel preparation for colonoscopy. Aliment Pharmacol Ther. 2007 Feb 15;25(4):373-84. doi: 10.1111/j.1365-2036.2006.03212.x. — View Citation
Froehlich F, Wietlisbach V, Gonvers JJ, Burnand B, Vader JP. Impact of colonic cleansing on quality and diagnostic yield of colonoscopy: the European Panel of Appropriateness of Gastrointestinal Endoscopy European multicenter study. Gastrointest Endosc. 2 — View Citation
Mytyk A, Lazowska-Przeorek I, Karolewska-Bochenek K, Kakol D, Banasiuk M, Walkowiak J, Albrecht P, Banaszkiewicz A. Clear Liquid Versus Low-fibre Diet in Bowel Cleansing for Colonoscopy in Children: A Randomized Trial. J Pediatr Gastroenterol Nutr. 2018 M — View Citation
Wu R, Ji WY, Yang C, Zhan Q. A Systematic Review and Meta-Analysis of Low-Residue Diet Versus Clear Liquid Diet: Which Is Better for Bowel Preparation Before Colonoscopy? Gastroenterol Nurs. 2021 Sep-Oct 01;44(5):341-352. doi: 10.1097/SGA.0000000000000554 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Boston Bowel Preparation Scale score | 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. |
After the children finish their bowel preparation, an average of 5 minutes | |
Secondary | Revised-Bristol Stool Form Scale score | 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. | After the children finish their bowel preparation, an average of 5 minutes. | |
Secondary | The times of enema | 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. | After the children finish their enema, an average of 1 minute. | |
Secondary | Number of defecation during bowel preparation | The number of defecation during bowel preparation will be recorded in the case report form by the nurse. | After the children finish their bowel preparation, an average of 1 minute. | |
Secondary | Medication compliance | 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. | After the children finish their bowel preparation, an average of 3 minutes. | |
Secondary | Adverse reactions of bowel preparation | 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. |
During children's bowel preparation, an average of 24 hours. |
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