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Comparison of Laparoscopic Nissen Versus Thal Fundoplication in Children

This study has been completed.
Sponsor:
Information provided by:
Oxford University Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT01027975
First received: December 7, 2009
Last updated: December 10, 2009
Last verified: February 2007
History of Changes
  Purpose

Laparoscopic fundoplication is increasingly performed in paediatric surgery. Many types of fundoplication are performed, each has advantages and disadvantages. The Nissen operation is the most frequently performed procedure in the U.K., however it can be associated with post-operative dysphagia. The relative benefits between Nissen and other fundoplication techniques in children are still uncertain.

The aim of our study was to compare the long-term outcomes following laparoscopic Nissen fundoplication with laparoscopic Thal fundoplication in children.


Condition Intervention
Gastroesophageal Reflux Disease
 Procedure: laparoscopic Nissen/laparoscopic Thal

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Long-term Outcome of Laparoscopic Nissen Fundoplication Compared With Laparoscopic Thal Fundoplication in Children

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Oxford University Hospitals NHS Trust:

Primary Outcome Measures:
  • Recurrence of symptoms sufficiently severe to justify the need for additional revisional surgery (i.e. failure of the original surgery) [ Designated as safety issue: No ]
  • Early death following surgery directly related to the fundoplication technique [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The resumption of symptoms bad enough to necessitate the re-introduction of anti-reflux medication (but not sufficiently bad to require revisional surgery) i.e. "intention to treat" [ Designated as safety issue: No ]
  • Post-operative complications (e.g. post-operative dysphagia) [ Designated as safety issue: No ]

Study Start Date: July 1998
  Eligibility

Ages Eligible for Study:   1 Month to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Gastro-oesophageal reflux unresponsive to medical treatment, or those who had serious complications (e.g. apnoea, aspiration pneumonia, oesophagitis)

Exclusion Criteria:

  • Patients who had previous anti-reflux surgery, previous open abdominal surgery, if parents declined to participate into study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01027975

Locations
United Kingdom
Department of Paediatric Surgery, John Radcliffe Hospital NHS Trust
Oxford (Headington), Oxford, United Kingdom, OX3 9DU
Sponsors and Collaborators
Oxford University Hospitals NHS Trust
Investigators
Study Director: Hugh W Grant, MD John Radcliffe Hospital, Department of Paediatric Surgery, Oxford,United Kingdom
Principal Investigator: Rainer Kubiak, MD John Radcliffe Hospital, Department of Paediatric Surgery, Oxford, United Kingdom
  More Information

No publications provided by Oxford University Hospitals NHS Trust

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Mr. Hugh W. Grant , Consultant Paediatric Surgeon, Department of Paediatric Surgery, John Radcliffe Hospital, Oxford, U.K.
ClinicalTrials.gov Identifier: NCT01027975     History of Changes
Other Study ID Numbers: RKubiak
Study First Received: December 7, 2009
Last Updated: December 10, 2009
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Oxford University Hospitals NHS Trust:
laparoscopy
fundoplication
Nissen
 Thal
children
operative treatment of gastro-oesophageal reflux disease in children

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

ClinicalTrials.gov processed this record on May 23, 2013