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Comparison of Laparoscopic Nissen Versus Thal 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.
ClinicalTrials.gov Identifier: NCT01027975
Recruitment Status : Completed
First Posted : December 9, 2009
Last Update Posted : December 11, 2009
Information provided by:

Study Description
Brief Summary:

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 or disease Intervention/treatment
Gastroesophageal Reflux Disease Procedure: laparoscopic Nissen/laparoscopic Thal

Study Design

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Long-term Outcome of Laparoscopic Nissen Fundoplication Compared With Laparoscopic Thal Fundoplication in Children
Study Start Date : July 1998

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Recurrence of symptoms sufficiently severe to justify the need for additional revisional surgery (i.e. failure of the original surgery)
  2. Early death following surgery directly related to the fundoplication technique

Secondary Outcome Measures :
  1. 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"
  2. Post-operative complications (e.g. post-operative dysphagia)

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 ClinicalTrials.gov identifier (NCT number): NCT01027975

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
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

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
First Posted: December 9, 2009    Key Record Dates
Last Update Posted: December 11, 2009
Last Verified: February 2007

Keywords provided by Oxford University Hospitals NHS Trust:
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