Comparison of Laparoscopic Nissen Versus Thal Fundoplication in Children
Not Applicable
Completed
- Conditions
- Gastroesophageal Reflux Disease
- Registration Number
- NCT01027975
- Lead Sponsor
- Oxford University Hospitals NHS Trust
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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)
Trial Locations
- Locations (1)
Department of Paediatric Surgery, John Radcliffe Hospital NHS Trust
🇬🇧Oxford (Headington), Oxford, United Kingdom