Laparoscopic Thal fundoplication in children: A very long-term follow-up study.

Gastroesophageal reflux disease (GERD) is a major healthcare problem affecting
the gastrointestinal tract of infants and children as well as adults. The
choice of therapy for GERD depends on the severity of the disease. Moderate
cases are treated with antireflux medication, whereas antireflux surgery (ARS)
is reserved for severe GERD patients. In 1998 a prospective pilot study by Van
der Zee et al, showed that although 90 percent of a patients were asymptomatic
after ARS, 25 percent still had pathological reflux as measured by pH metry.
Long-term efficacy of ARS has never been investigated prospectively. Recently,
an increased incidence of reflux complaints was detected in the patient
population that was published in 1998. In up to 33 percent of these patients
reflux complaints were present 10-15 years after ARS. Considering that there
was a significant discrepancy between reflux symptoms and objective pH
monitoring after short-term follow-up, it is conceivable that even a larger
percentage of patients will have objective pathological reflux 10-15 years
after ARS. Therefore, it is essential to objectively measure the efficacy of
antireflux surgery on gastroesophageal reflux 10-15 years after ARS.

Study the very long-term efficacy (regarding reflux control) of antireflux
surgery in children with severe GERD.

A prospective, very long-term follow-up study on gastroesophageal reflux 10 to
15 years after antireflux surgery for severe GERD.

Methods:
All patients will undergo a 24-hour pH monitoring 10-15 years after
laparoscopic Thal fundoplication.

The risk of the investigation technique for adults and children is negligible.
The 24-hour pH monitoring is currently the standard investigation technique for
evaluation of reflux disease.