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Unable to recruit a sufficient number of subjects.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal pH, abnormal Impedance | Active Comparator | 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 |
|
| Abnormal pH | Placebo Comparator | After 24hr pH-metry and impedance, those with abnormal pH scores (i.e. DeMeester score >14.7)will be offered anti-reflux surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anti-reflux surgery | Procedure | Anti-reflux surgery (Laparoscopic Nissen Fundoplication) |
|
| 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 |
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Inclusion Criteria:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Ellie Mentler, MD | United States Naval Medical Center, Portsmouth | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Naval Medical Center Portsmouth | Portsmouth | Virginia | 23708 | United States |
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