VA Cooperative Studies Program (CSP)

Investigator Access

What's Available

Check with the study contact and publications for information on a public dataset, data archive, data enclave, or website where data might be available.

Available Documentation

Dates Data are Available

Access Criteria

Study Characteristics

Objectives

To compare the efficacy of laparoscopic Nissen fundoplication and medical therapy that includes baclofen and desipramine, for patients with gastroesophageal reflux disease (GERD) who, while on proton pump inhibitors (PPI), have episodes of heartburn that are associated with reflux episodes or with abnormal esophageal acid exposure by esophageal pH/ multichannel intraluminal impedance (MII) monitoring, and to compare the efficacy of each therapy to placebo.

Era of Service

All

Population

Male and female patients who had heartburn that was refractory to PPI therapy and who were receiving care at 15 VA medical centers across the U.S.

Study Design

Randomized, double-blinded, parallel clinical trial

Interventions

Arm 1: Surgical treatment (Nissen fundoplication)
Arm 2: Active medical treatment (active PPI, baclofen and desipramine)
Arm 3: Placebo medical treatment (active PPI, placebo baclofen, placebo desipramine)

Time Period

August 2012 – December 2016

Setting

National

N

78 participants (surgical n=27, medical n=25, placebo n=26)

Response Rate

Success in achieving ≥ 50% improvement in the GERD-Health Related Quality of Life Questionnaire (GERD-HRQL) score:

• Surgical: 18 of 27 (67%)
• Medical: 7 of 25 (28%)
• Placebo: 3 of 26 (12%)
   

Recruitment Method

• Potential participants were identified by providers and study personnel at participating VA medical centers
• Once identified, the patients’ physicians were contacted to request that those patients be referred for possible participation
• Upon referral to the clinic of the local site investigator, study personnel approached participants regarding the study

Compensation

• $50 at each of 3 quarterly clinic visits
• $150 upon completion of one-year evaluations

Data Collected

Primary outcome: Treatment success, defined as an improvement (decrease) of 50% or more in the GERD-HRQL score from baseline to 12 months

Secondary outcomes

• Anxiety and depression
• Functional gastrointestinal disorders (ROME III Functional GI Disorders Questionnaire): heartburn, chest pain of presumed esophageal origin, dysphagia, globus, belching, nausea, vomiting, irritable bowel syndrome, bloating, diarrhea, unspecified functional bowel disorder, gallbladder disorder  

Other assessments:

• Demographics, medical history, pregnancy test, laboratory, and physical exam results
• Short-Form Health Survey (SF-26)         

Data Collection Methods

• Patient surveys and questionnaires
• Symptom scoring and laboratory testing
• Repeat endoscopy, esophageal manometry, and esophageal pH/impedance monitoring

Funding Source

VA Cooperative Studies Program (CSP)

Investigators

Study Chair: Stuart J. Spechler, MD

Contact

Leslie (Erin) Norman, Project Manager, Perry Point CSPCC, Leslie.Norman@va.gov

Selected Publications

Spechler SJ, Hunter JG, Jones KM, et al. Randomized trial of medical versus surgical treatment for refractory heartburn. N Engl J Med 2019;381:1513-1523. 

More Information

Study ClinicalTrials.gov site
ClinicalTrials.gov Identifier: NCT01265550