Is Laparoscopic Fundoplication Better Than Open Fundoplication in Children ?

March 9, 2012 updated by: Oslo University Hospital

IS Laparoscopic Fundoplication Superior to Open Fundoplication in Children - a Randomized Study

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0424
        • Oslo University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Open fundoplication
Fundoplication performed with open surgery
Procedure: Fundoplication
Primary fundoplication
Other Names:
  • Gastroesophageal reflux
Experimental: Lap fundoplication
Primary fundoplication performed by laparoscopic surgery
Procedure: Fundoplication
Primary fundoplication
Other Names:
  • Gastroesophageal reflux

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence of reflux
Time Frame: 12, 24 and 48 months
GER symptoms and GER on pH monitoring. Need for redo fundoplication. PPI.
12, 24 and 48 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative complication rate
Time Frame: 30 days
Perioperative complications. Duration of surgery. Postoperative complications. Lenght of hospital stay. Readmission to hospital.
30 days
Inflammatory response
Time Frame: The first 4 p.o days
indicies of inflammatory response
The first 4 p.o days
Parental stress
Time Frame: 12 and 24 months
Indicies of parental stress caused by GER pre- and postoperatively
12 and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Collaborators

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.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

March 8, 2012

First Submitted That Met QC Criteria

March 9, 2012

First Posted (Estimate)

March 12, 2012

Study Record Updates

Last Update Posted (Estimate)

March 12, 2012

Last Update Submitted That Met QC Criteria

March 9, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S-03082

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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