Is Laparoscopic Fundoplication Better Than Open Fundoplication in Children ?

This study has been terminated.
(Fewer patients than anticipated were referred)
Sponsor:
Collaborator:
University of Oslo
Information provided by (Responsible Party):
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01551134
First received: March 8, 2012
Last updated: March 9, 2012
Last verified: March 2012
  Purpose

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


Condition Intervention
Gastroesophageal Reflux
Procedure: Fundoplication

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: IS Laparoscopic Fundoplication Superior to Open Fundoplication in Children - a Randomized Study

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Recurrence of reflux [ Time Frame: 12, 24 and 48 months ] [ Designated as safety issue: No ]
    GER symptoms and GER on pH monitoring. Need for redo fundoplication. PPI.


Secondary Outcome Measures:
  • Postoperative complication rate [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Perioperative complications. Duration of surgery. Postoperative complications. Lenght of hospital stay. Readmission to hospital.

  • Inflammatory response [ Time Frame: The first 4 p.o days ] [ Designated as safety issue: No ]
    indicies of inflammatory response

  • Parental stress [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
    Indicies of parental stress caused by GER pre- and postoperatively


Enrollment: 88
Study Start Date: January 2003
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Open fundoplication
Fundoplication performed with open surgery
Procedure: Fundoplication
Primary fundoplication
Other Names:
  • Gastroesophageal reflux
  • Fundoplication
Experimental: Lap fundoplication
Primary fundoplication performed by laparoscopic surgery
Procedure: Fundoplication
Primary fundoplication
Other Names:
  • Gastroesophageal reflux
  • Fundoplication

  Eligibility

Ages Eligible for Study:   up to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01551134

Locations
Norway
Oslo University Hospital
Oslo, Norway, 0424
Sponsors and Collaborators
Oslo University Hospital
University of Oslo
Investigators
Principal Investigator: Kristin Bjornland, MD, PhD Department of hepatic, gastrointestinal and pediatric surgery, Oslo University Hospital HF, Rikshospitalet, Postboks 4950 Nydalen, 0424 Oslo, NORWAY.
  More Information

No publications provided

Responsible Party: Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01551134     History of Changes
Other Study ID Numbers: S-03082
Study First Received: March 8, 2012
Last Updated: March 9, 2012
Health Authority: Norway: Regional Ethics Commitee

Keywords provided by Oslo University Hospital:
Gastroesophageal Reflux
Fundoplication
Randomized Controlled Trial
General Surgery
Child
Laparoscopy

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 15, 2014