Trials Sponsors Conditions Drugs Pricing

Conditions

Non-acid Reflux Disease

Keywords

Nissen fundoplicationnon-acid reflux diseaseanti-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 surgeryProcedure

Anti-reflux surgery (Laparoscopic Nissen Fundoplication)

Abnormal pHNormal pH, abnormal Impedance

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age17 Years+

Sexall

Healthy VolunteersNo

Age GroupsChild (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:

Sponsors & Collaborators

United States Naval Medical Center, Portsmouth
US federal agencylead

Study Sites (1)

Naval Medical Center Portsmouth

Portsmouth, Virginia, 23708, United States

Study Officials

Ellie Mentler, MD
United States Naval Medical Center, Portsmouth
PRINCIPAL INVESTIGATOR

Enrollment

12 participants (actual enrollment reported by the registry).

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 2010

Actual (reported)

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Normal pH, abnormal Impedance

Abnormal pH

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Normal pH, abnormal Impedance

Abnormal pH

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations