One hundred and twenty patients with documented extraesophageal symptoms of gastroesophageal reflux disease were randomized to either undergo floppy Nissen (n= 60) or Toupet fundoplication (n= 60). Symptom scores of extraesophageal symotoms and quality of life were prospectively evaluated. Analysis of the treatment results showed a significant improvement of symptoms in both patient groups.Quality of life improved substantially at short- and long-term follow up in both groups and there were no statistical differences between the groups in this parameter.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
120
Creation of either a 360° (in Nissen group) or a 270° (in Toupet group) fundoplication wrap over a 30-Fr intra-esophageal bougie.
Danylo Halytsky Lviv National Medical University
Lviv, Ukraine
Symptom scores of throat clearing, globus sensation, cough, throat pain, vocal changes.
Time frame: 24 month
Reflux symptom index (RSI) score
The reflux symptom index (RSI) questionnaire is a nine-item, 45-point survey used in the evaluation of symptoms of laryngopharyngeal reflux. A RSI score higher than 13 is considered abnormal and indicates the presence of laryngopharyngeal reflux.
Time frame: 24 months
laryngopharyngeal reflux-health-related quality of life (LPR-HRQL) questionnaire score
The LPR-HRQL questionnaire is a 43-item survey, designed to assess the effects of extraesophageal reflux symptoms on social and occupational functioning, vitality, well-being and perceived health.
Time frame: 24 months
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