Is Laparoscopic Fundoplication Better Than Open Fundoplication in Children ?

Oslo University Hospital88 enrolled

Overview

The aim of the study was to compare short- and longterm outcomes after laparoscopic and open Nissen fundoplication in children.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Gastroesophageal Reflux

Interventions

FundoplicationPROCEDURE

Primary fundoplication

FundoplicationPROCEDURE

Primary fundoplication

Eligibility

Sex: ALLMax age: 15 Years

Medical Language ↔ Plain English

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)

Locations (1)

Oslo University Hospital

Oslo, Oslo County, Norway

Outcomes

Primary Outcomes

Recurrence of reflux

GER symptoms and GER on pH monitoring. Need for redo fundoplication. PPI.

Time frame: 12, 24 and 48 months

Secondary Outcomes

Postoperative complication rate

Perioperative complications. Duration of surgery. Postoperative complications. Lenght of hospital stay. Readmission to hospital.

Time frame: 30 days

Inflammatory response

indicies of inflammatory response

Time frame: The first 4 p.o days

Parental stress

Indicies of parental stress caused by GER pre- and postoperatively

Time frame: 12 and 24 months

Data from ClinicalTrials.gov

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