Comparison of Laparoscopic Nissen Versus Thal Fundoplication in Children

Sponsor

Oxford University Hospitals NHS Trust (Other)

Overall Status

Completed

CT.gov ID

NCT01027975

Collaborator

(none)

Location

Study Details

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	Phase
Gastroesophageal Reflux Disease	Procedure: laparoscopic Nissen/laparoscopic Thal	N/A

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

Long-term Outcome of Laparoscopic Nissen Fundoplication Compared With Laparoscopic Thal Fundoplication in Children

Study Start Date :

Jul 1, 1998

Outcome Measures

Primary Outcome Measures

Recurrence of symptoms sufficiently severe to justify the need for additional revisional surgery (i.e. failure of the original surgery) []
Early death following surgery directly related to the fundoplication technique []

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" []
Post-operative complications (e.g. post-operative dysphagia) []

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Month to 21 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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