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

NCT01241149 | Terminated DMC

• 1 other identifier: CIP# 10.0090
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Keywords

Nissen fundoplication; non-acid reflux disease; anti-reflux surgery

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Study Arms (2)

Normal pH, abnormal Impedance

ACTIVE COMPARATOR

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

Abnormal pH

PLACEBO COMPARATOR

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

Interventions

anti-reflux surgery PROCEDURE

Anti-reflux surgery (Laparoscopic Nissen Fundoplication)

Abnormal pH; Normal pH, abnormal Impedance

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• United States Naval Medical Center, Portsmouth: lead

Study Sites (1)

Naval Medical Center Portsmouth

Portsmouth, Virginia, 23708, United States

Location

Study Officials

• Ellie Mentler, MD

  United States Naval Medical Center, Portsmouth

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2010
• First Posted: November 16, 2010
• Study Start: November 1, 2010
• Primary Completion: March 26, 2014
• Study Completion: March 26, 2014
• Last Updated: August 15, 2025

Record last verified: 2025-08

Locations

US (1)