Is Laparoscopic Fundoplication Better Than Open Fundoplication in Children ?
Not Applicable
Terminated
- Conditions
- Gastroesophageal Reflux
- Registration Number
- NCT01551134
- Lead Sponsor
- Oslo University Hospital
- Brief Summary
The aim of the study was to compare short- and longterm outcomes after laparoscopic and open Nissen fundoplication in children.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 88
Inclusion Criteria
- Age 0-15 years
- All patients accepted for primary fundoplication at Oslo University Hospital
Exclusion Criteria
- Age over 16 years
- Parents not speaking Norwegian or English well
- Prior fundoplication
- Patients with comorbidities considered as unsuited for laparoscopic surgery (diaphragma hernia, several previous abdominal operations etc)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Recurrence of reflux 12, 24 and 48 months GER symptoms and GER on pH monitoring. Need for redo fundoplication. PPI.
- Secondary Outcome Measures
Name Time Method Postoperative complication rate 30 days Perioperative complications. Duration of surgery. Postoperative complications. Lenght of hospital stay. Readmission to hospital.
Inflammatory response The first 4 p.o days indicies of inflammatory response
Parental stress 12 and 24 months Indicies of parental stress caused by GER pre- and postoperatively
Trial Locations
- Locations (1)
Oslo University Hospital
🇳🇴Oslo, Norway
Oslo University Hospital🇳🇴Oslo, Norway