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Procedure
Anti-reflux Surgery for Reflux Disease
N/A
Waitlist Available
Led By Ellie Mentler, MD
Research Sponsored by United States Naval Medical Center, Portsmouth
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial will compare outcomes for patients with either acid or non-acid reflux disease who have undergone anti-reflux surgery.
Who is the study for?
This trial is for individuals with severe acid reflux or those whose symptoms don't improve with medication. Eligible participants have specific test results indicating reflux (DeMeester scores) and are adults but not pregnant, without a BMI over 40, no major upper GI surgeries except gallbladder removal, and no severe esophageal motility disorders.Check my eligibility
What is being tested?
The study aims to compare the effectiveness of anti-reflux surgery in patients suffering from acid versus non-acid reflux disease. It will use quality of life surveys to measure outcomes post-surgery.See study design
What are the potential side effects?
While the side effects aren't detailed here, typical risks associated with anti-reflux surgery may include difficulty swallowing, bloating, discomfort at the surgical site, and temporary changes in bowel habits.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Operative Surgical Procedures
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Normal pH, abnormal ImpedanceActive Control1 Intervention
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 II: Abnormal pHPlacebo Group1 Intervention
After 24hr pH-metry and impedance, those with abnormal pH scores (i.e. DeMeester score >14.7)will be offered anti-reflux surgery
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Who is running the clinical trial?
United States Naval Medical Center, PortsmouthLead Sponsor
31 Previous Clinical Trials
4,300 Total Patients Enrolled
Ellie Mentler, MDPrincipal InvestigatorUnited States Naval Medical Center, Portsmouth
1 Previous Clinical Trials
98 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had major surgery on my esophagus, stomach, or duodenum, but gallbladder removal is okay.I have a type II to IV paraesophageal hernia.I am recommended for anti-reflux surgery due to my high acid levels or positive symptom index.I have a large hiatal hernia over 5cm.I have a narrowing in my stomach or upper small intestine.I have a severe disorder affecting my esophagus or have poorly-controlled diabetes, nerve, or muscle issues.My surgery was changed to an open procedure.I am under 18 years old.I will have a Collis gastroplasty during my surgery.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there vacancies available for those seeking to participate in this trial?
"Unfortunately, the trial is no longer actively recruiting and has not been updated since November 15th 2010. However, there are 67 other trials that are open for enrollment at this time."
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