search
Back to results

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

Primary Purpose

Non-acid Reflux Disease

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
anti-reflux surgery
Sponsored by
United States Naval Medical Center, Portsmouth
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-acid Reflux Disease focused on measuring Nissen fundoplication, non-acid reflux disease, anti-reflux surgery

Eligibility Criteria

17 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Naval Medical Center PortsmouthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Normal pH, abnormal Impedance

Abnormal pH

Arm Description

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

After 24hr pH-metry and impedance, those with abnormal pH scores (i.e. DeMeester score >14.7)will be offered anti-reflux surgery

Outcomes

Primary Outcome Measures

Effectiveness of anti-reflux surgery
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.

Secondary Outcome Measures

Full Information

First Posted
November 15, 2010
Last Updated
November 15, 2010
Sponsor
United States Naval Medical Center, Portsmouth
search

1. Study Identification

Unique Protocol Identification Number
NCT01241149
Brief Title
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

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Unknown status
Study Start Date
November 2010 (undefined)
Primary Completion Date
November 2013 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
United States Naval Medical Center, Portsmouth

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-acid Reflux Disease
Keywords
Nissen fundoplication, non-acid reflux disease, anti-reflux surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Normal pH, abnormal Impedance
Arm Type
Active Comparator
Arm Description
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
Arm Title
Abnormal pH
Arm Type
Placebo Comparator
Arm Description
After 24hr pH-metry and impedance, those with abnormal pH scores (i.e. DeMeester score >14.7)will be offered anti-reflux surgery
Intervention Type
Procedure
Intervention Name(s)
anti-reflux surgery
Intervention Description
Anti-reflux surgery (Laparoscopic Nissen Fundoplication)
Primary Outcome Measure Information:
Title
Effectiveness of anti-reflux surgery
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ellie Mentler, MD
Phone
757-953-2454
Email
ellie.mentler@med.navy.mil
First Name & Middle Initial & Last Name or Official Title & Degree
Charles Morgan, PhD
Phone
757-953-5939
Email
charles.morgan@med.navy.mil
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ellie Mentler, MD
Organizational Affiliation
United States Naval Medical Center, Portsmouth
Official's Role
Principal Investigator
Facility Information:
Facility Name
Naval Medical Center Portsmouth
City
Portsmouth
State/Province
Virginia
ZIP/Postal Code
23708
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ellie Mentler, MD
Phone
757-953-2454
Email
ellie.mentler@med.navy.mil
First Name & Middle Initial & Last Name & Degree
Charles Morgan, PhD
Phone
757-953-5939
Email
charles.morgan@med.navy.mil
First Name & Middle Initial & Last Name & Degree
Ellie Mentler, MD
First Name & Middle Initial & Last Name & Degree
Cade Cinnamond, DO
First Name & Middle Initial & Last Name & Degree
Michael Barker, MD
First Name & Middle Initial & Last Name & Degree
John Smith, MD
First Name & Middle Initial & Last Name & Degree
Andrew Gentry, MD
First Name & Middle Initial & Last Name & Degree
Delores Rhodes, MD

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs