Gastroesophageal Reflux
Conditions
Keywords
Gastroesophageal Reflux, Fundoplication, Randomized Controlled Trial, General Surgery, Child, Laparoscopy
Brief summary
The aim of the study was to compare short- and longterm outcomes after laparoscopic and open Nissen fundoplication in children.
Interventions
PROCEDUREFundoplication
Primary fundoplication
Sponsors
University of Oslo
Oslo University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 15 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence of reflux | 12, 24 and 48 months | GER symptoms and GER on pH monitoring. Need for redo fundoplication. PPI. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Norway
Outcome results
None listed