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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by United States Naval Medical Center, Portsmouth.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
United States Naval Medical Center, Portsmouth
ClinicalTrials.gov Identifier:
NCT01241149
First received: November 15, 2010
Last updated: NA
Last verified: November 2010
History: No changes posted

November 15, 2010
November 15, 2010
November 2010
November 2013   (final data collection date for primary outcome measure)
Effectiveness of anti-reflux surgery [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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.
Same as current
No Changes Posted
Not Provided
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Prospective Evaluation of Symptom Resolution in Acid Versus Non-acid Reflux Disease Following Anti-reflux Surgery
Prospective Evaluation of Symptom Resolution in Acid Versus Non-acid Reflux Disease Following Anti-reflux Surgery.

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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-acid Reflux Disease
Procedure: anti-reflux surgery
Anti-reflux surgery (Laparoscopic Nissen Fundoplication)
  • Active Comparator: Normal pH, abnormal Impedance
    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
    Intervention: Procedure: anti-reflux surgery
  • Placebo Comparator: Abnormal pH
    After 24hr pH-metry and impedance, those with abnormal pH scores (i.e. DeMeester score >14.7)will be offered anti-reflux surgery
    Intervention: Procedure: anti-reflux surgery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
32
Not Provided
November 2013   (final data collection date for primary outcome measure)

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
Both
17 Years and older
No
Contact: Ellie Mentler, MD 757-953-2454 ellie.mentler@med.navy.mil
Contact: Charles Morgan, PhD 757-953-5939 charles.morgan@med.navy.mil
United States
 
NCT01241149
CIP# 10.0090
Yes
LT Ellie Mentler, Naval Medical Center Portsmouth
United States Naval Medical Center, Portsmouth
Not Provided
Principal Investigator: Ellie Mentler, MD United States Naval Medical Center, Portsmouth
United States Naval Medical Center, Portsmouth
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP