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Is Laparoscopic Fundoplication Better Than Open Fundoplication in Children ?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01551134
Recruitment Status : Terminated (Fewer patients than anticipated were referred)
First Posted : March 12, 2012
Last Update Posted : March 12, 2012
University of Oslo
Information provided by (Responsible Party):
Oslo University Hospital

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

Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Procedure: Fundoplication Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
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
Study Start Date : January 2003
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. Postoperative complication rate [ Time Frame: 30 days ]
    Perioperative complications. Duration of surgery. Postoperative complications. Lenght of hospital stay. Readmission to hospital.

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

  3. Parental stress [ Time Frame: 12 and 24 months ]
    Indicies of parental stress caused by GER pre- and postoperatively

Information from the National Library of Medicine

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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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01551134

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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Oslo University Hospital Identifier: NCT01551134    
Other Study ID Numbers: S-03082
First Posted: March 12, 2012    Key Record Dates
Last Update Posted: March 12, 2012
Last Verified: March 2012
Keywords provided by Oslo University Hospital:
Gastroesophageal Reflux
Randomized Controlled Trial
General Surgery
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases