|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
21 December 2015 |
|
Main ID: |
NCT02407639 |
|
Date of registration:
|
18/03/2015 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Insufflation in Children Undergoing Colonoscopy
|
|
Scientific title:
|
Randomized, Double-blind Trial of CO2 vs. Air Insufflation in Children Undergoing Colonoscopy |
|
Date of first enrolment:
|
March 2015 |
|
Target sample size:
|
78 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02407639 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
|
|
Phase:
|
Phase 4
|
|
|
Countries of recruitment
|
|
Slovenia
| | | | | | | |
|
Contacts
|
|
Name:
|
Matjaž Homan, PhD MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
UMC Ljubljana |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- indication for colonoscopy
Exclusion Criteria:
- PM retardation
- postprocedural complications regarding sedation
Age minimum:
7 Years
Age maximum:
18 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Children
|
|
Colonoscopy
|
|
Intervention(s)
|
|
Other: air
|
|
Other: CO2
|
|
Primary Outcome(s)
|
|
to compare post-procedural abdominal pain in children undergoing colonoscopy using CO2 or air for insufflation.
[Time Frame: 24 hours]
|
|
Secondary Outcome(s)
|
|
to compare post-procedural girth in children undergoing colonoscopy using CO2 or air for insufflation.
[Time Frame: 4 hours]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|