Is Laparoscopic Fundoplication Better Than Open Fundoplication in Children ?

University of Oslo (UIO)

Status: Terminated

Conditions: Gastroesophageal Reflux

Treatments: Procedure: Fundoplication

Study type: Interventional

Funder types: Other

Identifiers

NCT01551134

S-03082

Details and patient eligibility

About

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

Enrollment: 88 patients

Sex: All

Ages: Under 15 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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88 participants in 2 patient groups

Open fundoplication

Active Comparator group

Description:

Fundoplication performed with open surgery

Treatment:

Procedure: Fundoplication

Procedure: Fundoplication

Lap fundoplication

Experimental group

Description:

Primary fundoplication performed by laparoscopic surgery

Treatment:

Procedure: Fundoplication

Procedure: Fundoplication