Intralesional Steroid Injections to Prevent Refractory Strictures in Patients with Esophageal Atresia – a randomized controlled trial (STEPS-EA)
Recruiting
- Conditions
- esophageal atresia, strictures, slokdarmatresie, stricturen, stenose
- Registration Number
- NL-OMON26384
- Lead Sponsor
- Erasmus MC - Sophia Children's Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 110
Inclusion Criteria
Children with EA type C who underwent primary anastomotic surgery within the first days of life
- Age >3 months at the time of the 3rd dilatation
- In need of a 3rd dilatation
- Written informed consent by both parents or legal representatives, if applicable
Exclusion Criteria
- Age <3 months
- Known inability from previous dilatations to use an endoscope with a size of 5.8 mm
- No parental written informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome parameter is the total number of dilatations per patient within 28 days interval required during the study period, defined as the period from the day of the 3rd dilatation until 6 months later.
- Secondary Outcome Measures
Name Time Method