Status:
TERMINATED
Prospective Evaluation of Symptom Resolution in Acid Versus Non-acid Reflux Disease Following Anti-reflux Surgery
Lead Sponsor:
United States Naval Medical Center, Portsmouth
Conditions:
Non-acid Reflux Disease
Eligibility:
All Genders
17+ years
Phase:
NA
Brief Summary
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 non...
Eligibility Criteria
Inclusion
- 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
- • 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
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 26 2014
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01241149
Start Date
November 1 2010
End Date
March 26 2014
Last Update
August 15 2025
Active Locations (1)
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1
Naval Medical Center Portsmouth
Portsmouth, Virginia, United States, 23708