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
  Purpose

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.


Condition Intervention
Non-acid Reflux Disease
Procedure: anti-reflux surgery

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Evaluation of Symptom Resolution in Acid Versus Non-acid Reflux Disease Following Anti-reflux Surgery.

Resource links provided by NLM:


Further study details as provided by United States Naval Medical Center, Portsmouth:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 32
Study Start Date: November 2010
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Procedure: anti-reflux surgery
Anti-reflux surgery (Laparoscopic Nissen Fundoplication)
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
Procedure: anti-reflux surgery
Anti-reflux surgery (Laparoscopic Nissen Fundoplication)

  Eligibility

Ages Eligible for Study:   17 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01241149

Contacts
Contact: Ellie Mentler, MD 757-953-2454 ellie.mentler@med.navy.mil
Contact: Charles Morgan, PhD 757-953-5939 charles.morgan@med.navy.mil

Locations
United States, Virginia
Naval Medical Center Portsmouth Recruiting
Portsmouth, Virginia, United States, 23708
Contact: Ellie Mentler, MD    757-953-2454    ellie.mentler@med.navy.mil   
Contact: Charles Morgan, PhD    757-953-5939    charles.morgan@med.navy.mil   
Principal Investigator: Ellie Mentler, MD         
Sub-Investigator: Cade Cinnamond, DO         
Sub-Investigator: Michael Barker, MD         
Sub-Investigator: John Smith, MD         
Sub-Investigator: Andrew Gentry, MD         
Sub-Investigator: Delores Rhodes, MD         
Sponsors and Collaborators
United States Naval Medical Center, Portsmouth
Investigators
Principal Investigator: Ellie Mentler, MD United States Naval Medical Center, Portsmouth
  More Information

No publications provided

Responsible Party: LT Ellie Mentler, Naval Medical Center Portsmouth
ClinicalTrials.gov Identifier: NCT01241149     History of Changes
Other Study ID Numbers: CIP# 10.0090
Study First Received: November 15, 2010
Last Updated: November 15, 2010
Health Authority: United States: Federal Government

Keywords provided by United States Naval Medical Center, Portsmouth:
Nissen fundoplication
non-acid reflux disease
anti-reflux surgery

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 29, 2014