Outcomes After Medical and Surgical Treatment of Gastroesophageal Reflux Disease

StatusActive, Not Recruiting
PhaseNot specified
Started

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Record History

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  1. Re-verified, no change to tracked fieldsv22
  2. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v21
  3. Trial status: Active, Not Recruiting to Recruiting
    • Site details revised
    v20
  4. 5 versions Re-verified since Oct 4, 2019, no change to tracked fieldsv15-v19
  5. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v14
Show 12 earlier versionsHide 12 earlier versions
  1. Enrollment target: 1500 to 2500
    • Eligibility criteria revised
    • Site contact updated
    v13
  2. Site contact updatedv12
  3. Site contact updatedv11
  4. Primary and study completion dates: Dec 2050v10
  5. Study site revisedv9
  6. 2 versions Re-verified since Oct 13, 2008, no change to tracked fieldsv7-v8
  7. Enrollment target: 500 to 1500
    • Interventions: Questionnaire to evaluate presence or absence of pain (Behavioral), Questionnaire to evaluate satisfaction with treatment (Behavioral)… to Questionnaire to evaluate presence or absence of pain (Behavioral), Questionnaire to evaluate satisfaction with treatment (Behavioral)…
    • Site contact updated
    v6
  8. 2 versions Re-verified since Jul 25, 2006, no change to tracked fieldsv4-v5
  9. Interventions: Questionnaire to evaluate presence or absence of pain. (Behavioral), Questionnaire to evaluate satisfaction with treatment (Behavioral)… to Questionnaire to evaluate presence or absence of pain (Behavioral), Questionnaire to evaluate satisfaction with treatment (Behavioral)…
    • Study description revised
    • Eligibility criteria expanded, about 1 word
    v3
  10. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The aims of this study are to create a prospective data base to evaluate the long term outcomes of medical and surgical treatment of gastroesophageal reflux disease (GERD); to measure standard outcomes as well as patient derived outcomes such as general and disease specific quality of life (QOL) issues and patient satisfaction; to refine the parameters that may identify patients who will benefit from surgery for GERD; and to identify possible determinants of failure of both medical and surgical treatments of reflux.
Trial Details
NCT Number NCT00260572
Lead Sponsor University of Pittsburgh
Conditions
(from sponsor)		 Gastroesophageal Reflux Disease
Related terms Dyspepsia, Gastroesophageal Reflux, Heartburn
Enrollment 2,500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov