Clinical trial NCT01241149: Prospective Evaluation of Symptom Resolution in Acid Versus Non-acid Reflux Disease Following Anti-reflux Surgery
Official title: Prospective Evaluation of Symptom Resolution in Acid Versus Non-acid Reflux Disease Following Anti-reflux Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-acid Reflux Disease
Keywords: Nissen fundoplication
non-acid reflux disease
anti-reflux surgery
Lead sponsor: United States Naval Medical Center, Portsmouth
Sponsor class: FED
First posted: 2010-11-16
Enrollment: 12
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Effectiveness of anti-reflux surgery
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Portsmouth
country: United States
facility: Naval Medical Center Portsmouth
state: Virginia
Study officials:
affiliation: United States Naval Medical Center, Portsmouth
name: Ellie Mentler, MD
role: PRINCIPAL_INVESTIGATOR
References: