Clinical trial NCT04525560: Efficacy, Safety and Tolerability of Different Bowel Preparation Before Colonoscopy in Children Over 2 Years Old
Official title: Efficacy, Safety and Tolerability of Different Bowel Preparation Before Colonoscopy in Children Over 2 Years Old
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Obesity
Bowel Preparation
Keywords: Child
Electronic colonoscopy
bowel preparation
polyethylene glycol with electrolyte solution
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2020-08-25
Enrollment: 315
Sex: ALL
Minimum age (years): 2
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Electronic colonoscopy plays an important role in the diagnosis and follow-up of intestinal diseases in children.

Detailed description: The adequacy of bowel preparation before colonoscopy is particularly important for the visualization of intestinal mucosa under colonoscopy. Some studies have shown that bowel preparation must be customized according to the age, weight and clinical status of the child. However, there is no internationally recognized standard scheme for pediatric intestinal reserve. In pediatric clinical trials, polyethylene glycol with electrolyte solution (PEG-ELS) is more effective than bisacodyl, folium sennae and magnesium citrate. PEG-ELS is an electrolyte balanced isotonic solution, which can be used to clean the intestinal tract by large volume irrigation. Polyethylene glycol 4000 is a long-chain linear polymer, which can hardly absorb and decompose after oral administration. It can effectively increase the composition of intestinal fluid, stimulate intestinal peristalsis, cause watery diarrhea, and achieve the purpose of cleaning the intestine. The inorganic salt composition and proper amount of water in the formula ensure the balance of water and electrolyte exchange between intestinal tract and body fluid. In this study, PEG-ELS short protocol and long protocol were selected for intestinal preparation, and the effectiveness and safety of different intestinal preparation protocols under electronic colonoscopy for children over 2 years old were compared.

Eligibility criteria: Inclusion Criteria:

* Newly diagnosed children in Department of Gastroenterology at Children's Hospital of Fudan University
* According to the indications of electronic colonoscopy, colonoscopy was performed for the first time
* Age: 2-22 years old

Exclusion Criteria:

* Having contraindications of electronic colonoscopy
* Having contraindications of general anesthesia
* Previous abdominal surgery
* Chronic constipation
* There is evidence of intestinal stenosis and gastrointestinal malformation
* Laxatives or drugs in the intestinal preparation protocol of this study have been used before bowel preparation
* Disagree the use of the bowel preparation protocol developed in the study

Primary outcomes:
measure: Bowel cleansing
timeFrame: During the operation of electronic colonoscopy (about 15 min )
Secondary outcomes:
measure: Compliance with polyethylene glycol with electrolyte solution (PEG-ELS)
timeFrame: During bowel preparation (about 24 hours)
measure: Adverse reactions receiving polyethylene glycol with electrolyte solution
timeFrame: During bowel preparation (about 24 hours)
measure: Rate of nasal feeding PEG-ELS
timeFrame: During bowel preparation (about 24 hours)
measure: Enema rate before colonoscopy
timeFrame: immediately before colonoscopy
measure: Times of washing under colonoscopy
timeFrame: During the operation of electronic colonoscopy (about 15 mins)
measure: Adverse events
timeFrame: up to 30 minutes after colonoscopy
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children's hospital of Fudan university
state: Shanghai
Study officials:
References: