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Comparison of Laparoscopic Nissen Versus Thal Fundoplication in Children

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01027975
Enrollment
Unknown
Registered
2009-12-09
Start date
1998-07-31
Completion date
Unknown
Last updated
2009-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroesophageal Reflux Disease

Keywords

laparoscopy, fundoplication, Nissen, Thal, children, operative treatment of gastro-oesophageal reflux disease in children

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.

Interventions

PROCEDURElaparoscopic Nissen/laparoscopic Thal

Sponsors

Oxford University Hospitals NHS Trust
Lead SponsorOTHER

Study design

Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Age
1 Months to 21 Years
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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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)

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 30, 2026