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

August 12, 2025 updated by: United States Naval Medical Center, Portsmouth

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Portsmouth, Virginia, United States, 23708
        • Naval Medical Center Portsmouth

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness of anti-reflux surgery
Time Frame: 1 year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

United States Naval Medical Center, Portsmouth

Investigators

  • Principal Investigator: Ellie Mentler, MD, United States Naval Medical Center, Portsmouth

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2010

Primary Completion (Actual)

March 26, 2014

Study Completion (Actual)

March 26, 2014

Study Registration Dates

First Submitted

November 15, 2010

First Submitted That Met QC Criteria

November 15, 2010

First Posted (Estimated)

November 16, 2010

Study Record Updates

Last Update Posted (Actual)

August 15, 2025

Last Update Submitted That Met QC Criteria

August 12, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIP# 10.0090

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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