Laparoscopic Total vs Partial Fundoplication in Patients With Atypical Symptoms of Gastroesophageal Reflux Disease

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective Randomized Trial on Laparoscopic Total vs Partial Fundoplication in Patients With Atypical Symptoms of Gastroesophageal Reflux Disease

Conditions
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Gastroesophageal Reflux Disease

Intervention / Treatment
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* Procedure: Laparoscopic fundoplication


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: extraesophageal symptoms of gastroesophageal reflux disease undergoing surgery for gastroesophageal reflux disease at least 18 years old Exclusion Criteria: patients under the age of 18 years previous anti-reflux surgery, other surgical procedures in the vicinity of the gastroesophageal junction major psychiatric illness unstable chronic illnesses (such as diabetes) inability of the patient to complete the survey.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: laparoscopic Nissen fundoplication<br>Creation of a 360° fundoplication wrap over a 30-Fr intra-esophageal bougie. | Procedure: Laparoscopic fundoplication<br>* Creation of either a 360° (in Nissen group) or a 270° (in Toupet group) fundoplication wrap over a 30-Fr intra-esophageal bougie.<br>|
| Active Comparator: laparoscopic Toupet fundoplication<br>Creation of a 270° fundoplication wrap over a 30-Fr intra-esophageal bougie. | Procedure: Laparoscopic fundoplication<br>* Creation of either a 360° (in Nissen group) or a 270° (in Toupet group) fundoplication wrap over a 30-Fr intra-esophageal bougie.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom scores of throat clearing, globus sensation, cough, throat pain, vocal changes. |  | 24 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 24 months |