This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Is Laparoscopic Fundoplication Better Than Open Fundoplication in Children ?

This study has been terminated.
(Fewer patients than anticipated were referred)
University of Oslo
Information provided by (Responsible Party):
Oslo University Hospital Identifier:
First received: March 8, 2012
Last updated: March 9, 2012
Last verified: March 2012
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
Intervention Model: Parallel Assignment
Masking: None (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 ]
    GER symptoms and GER on pH monitoring. Need for redo fundoplication. PPI.

Secondary Outcome Measures:
  • Postoperative complication rate [ Time Frame: 30 days ]
    Perioperative complications. Duration of surgery. Postoperative complications. Lenght of hospital stay. Readmission to hospital.

  • Inflammatory response [ Time Frame: The first 4 p.o days ]
    indicies of inflammatory response

  • Parental stress [ Time Frame: 12 and 24 months ]
    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 Name: Gastroesophageal reflux
Experimental: Lap fundoplication
Primary fundoplication performed by laparoscopic surgery
Procedure: Fundoplication
Primary fundoplication
Other Name: Gastroesophageal reflux


Ages Eligible for Study:   up to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01551134

Oslo University Hospital
Oslo, Norway, 0424
Sponsors and Collaborators
Oslo University Hospital
University of Oslo
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

Responsible Party: Oslo University Hospital Identifier: NCT01551134     History of Changes
Other Study ID Numbers: S-03082
Study First Received: March 8, 2012
Last Updated: March 9, 2012

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

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases processed this record on August 22, 2017