Assessing Outcomes After Surgery for Gastroesophageal Reflux Disorder (GERD)
This study is currently recruiting participants.
Verified August 2012 by University of South Florida
Sponsor:
University of South Florida
Information provided by (Responsible Party):
Kenneth Luberice, University of South Florida
ClinicalTrials.gov Identifier:
NCT00518505
First received: August 16, 2007
Last updated: August 14, 2012
Last verified: August 2012
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Purpose
The purpose of this study is to review pre-operative studies and patient evaluation reports and compare those with the results of the post-operative studies, patient evaluation reports and subjective patients' outcomes following laparoscopic surgery for gastroesophageal reflux disorder. This will allow us to evaluate how patients have benefited from the procedure.
| Condition | Intervention |
|---|---|
|
Gastroesophageal Reflux Disorder |
Other: Symptom questionnaire |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Health Services Research |
| Official Title: | Long and Short Term Outcomes After Laparoscopic Surgery for Gastroesophageal Reflux Disease |
Resource links provided by NLM:
Further study details as provided by University of South Florida:
Primary Outcome Measures:
- The objective of this study is to review pre-operative studies and evaluation reports and compare those with post-operative studies and evaluation reports to evaluate outcome following laparoscopic surgery for GERD. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 1500 |
| Study Start Date: | December 2006 |
| Estimated Study Completion Date: | September 2017 |
| Estimated Primary Completion Date: | September 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
I
This is a single arm study. All patients will be asked to complete questionnaires and have their medical charts reviewed.
|
Other: Symptom questionnaire
This questionnaire will assess patient outcomes before and after surgery for gastroesophageal reflux disorder.
|
Detailed Description:
This study will include all patients who have laparoscopic surgery for gastroesophageal reflux disorder. Patients who participate will be asked to answer questionnaires regarding symptoms of reflux before and after surgery. In addition medical charts will be reviewed for relevant data.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- patients must have GERD and must plan to have laparoscopic surgery for GERD.
- patients must be at least 18 years of age
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00518505
Contacts
| Contact: Jennifer C Cooper, B.S. | 813-844-4218 ext 4218 | jcooper@health.usf.edu |
| Contact: Carl B Bowers, R.N. | 813-844-7529 ext 7529 | cowers@health.usf.edu |
Locations
| United States, Florida | |
| Tampa General Hospital/University of South Florida | Recruiting |
| Tampa, Florida, United States, 33606 | |
| Contact: Jennifer C. Cooper, B.S. 813-844-4218 ext 4218 jcooper@health.usf.edu | |
| Contact: Carl B Bowers, R.N. 813-844-7529 ext 7529 cbowers@health.usf.edu | |
Sponsors and Collaborators
University of South Florida
Investigators
| Study Director: | Alexander S Rosemurgy, M.D. | University of South Florida |
More Information
No publications provided
| Responsible Party: | Kenneth Luberice, Principal Investigator, University of South Florida |
| ClinicalTrials.gov Identifier: | NCT00518505 History of Changes |
| Other Study ID Numbers: | 105238 |
| Study First Received: | August 16, 2007 |
| Last Updated: | August 14, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of South Florida:
|
GERD, laparoscopic surgery |
Additional relevant MeSH terms:
|
Gastroesophageal Reflux Esophageal Motility Disorders Deglutition Disorders |
Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013