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
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 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 August 28, 2014