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

NCT ID: NCT01241149

Last Updated: 2025-08-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2014-03-26

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.

Conditions

Non-acid Reflux Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

anti-reflux surgery

Intervention Type: PROCEDURE

Anti-reflux surgery (Laparoscopic Nissen Fundoplication)

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

Group Type: PLACEBO_COMPARATOR

anti-reflux surgery

Intervention Type: PROCEDURE

Anti-reflux surgery (Laparoscopic Nissen Fundoplication)

Interventions

anti-reflux surgery

Anti-reflux surgery (Laparoscopic Nissen Fundoplication)

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Naval Medical Center, Portsmouth

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ellie Mentler, MD

Role: PRINCIPAL_INVESTIGATOR

United States Naval Medical Center, Portsmouth

Locations

Naval Medical Center Portsmouth

Portsmouth, Virginia, United States

Countries

United States

Other Identifiers

CIP# 10.0090

Identifier Type: -

Identifier Source: org_study_id