Prospective Evaluation of Symptom Resolution in Acid Versus Non-acid Reflux Disease Following Anti-reflux Surgery

Study Overview
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Brief Summary
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Gastroesophageal reflux disease (GERD) is a common ailment affecting a significant portion of the US population. With the advent and increased use of esophageal impedance monitoring, both acid and nonacid reflux disease can be better diagnosed and treated. Patients with severe symptoms or symptoms refractory to medical management may be offered anti-reflux surgery for optimal treatment. Though there are a handful of studies evaluating the efficacy of anti-reflux surgery on those patients with acid or non-acid related reflux disease, the comparison between acid and non-acid reflux disease following surgery is lacking. We propose a prospective study comparing clinical outcomes from those patients with acid versus non-acid reflux disease following anti-reflux surgery with the use of validated and disease specific quality of life surveys.

Official Title
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Prospective Evaluation of Symptom Resolution in Acid Versus Non-acid Reflux Disease Following Anti-reflux Surgery.

Conditions
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Non-acid Reflux Disease

Intervention / Treatment
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* Procedure: anti-reflux surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are offered anti-reflux surgical treatment with elevated DeMeester scores or with low (less than 14.7) DeMeester scores, but with positive impedance scores (positive symptom index associated with reflux episodes). Exclusion Criteria: • Previous major upper gastrointestinal surgery (includes esophagus, stomach, and duodenum) - previous cholecystectomy (gallbladder removal) is not considered a major upper GI surgery Presence of paraesophageal hernia (type II - type IV) Presence of large hiatal hernia >5cm Presence of peptic strictures History of severe esophageal motility disorders such as: achalasia diffuse esophageal spasms scleroderma poorly-controlled diabetes mellitus autonomic or peripheral neuropathy myopathy Pregnancy (As a standard operating procedure, women of child-bearing age will undergo a urine pregnancy test the morning of surgery because anti-reflux surgery is considered an elective case, where pregnancy is a relative contraindication.) BMI greater than 40 Undergoes Collis gastroplasty during surgery Conversion to an open procedure Age less than 18 years old

Ages Eligible for Study
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Minimum Age: 17 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Normal pH, abnormal Impedance<br>After 24hr pH-metry and impedance, those patients with normal pH (i.e. DeMeester score <14.7) but with abnormal impedance scores will be offered anti-reflux surgery | Procedure: anti-reflux surgery<br>* Anti-reflux surgery (Laparoscopic Nissen Fundoplication)<br>|
| Placebo Comparator: Abnormal pH<br>After 24hr pH-metry and impedance, those with abnormal pH scores (i.e. DeMeester score >14.7)will be offered anti-reflux surgery | Procedure: anti-reflux surgery<br>* Anti-reflux surgery (Laparoscopic Nissen Fundoplication)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of anti-reflux surgery | To prospectively evaluate the effectiveness of anti-reflux surgery, as measured by symptom reduction, in the treatment of nonacid reflux disease compared prospectively with acid reflux disease. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nissen fundoplication, non-acid reflux disease, anti-reflux surgery