Ignite Creation Date:
2024-05-05 @ 12:11 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00260572
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-20
First Post:
2005-11-28
Brief Title:
Outcomes After Medical and Surgical Treatment of Gastroesophageal Reflux Disease
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Outcomes After Medical and Surgical Treatment of Gastroesophageal Reflux Disease
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
GERD is a significant public health problem and when it is severe it may have a considerable impact on patients QOL Relatively new treatments such as proton pump inhibitors PPI and laparoscopic fundoplication wrapping or gathering the stomach around the lower end of the esophagus to reduce or prevent reflux are now available Patient derived outcomes such as QOL and satisfaction are rarely taken into consideration when evaluating such new treatments Outcome analysis of the results of medical and surgical treatments using an ongoing database of patients will enhance our ability to treat patients with GERD
This studys goal is to build a database to collect the outcome information on patients who are having medical or surgical treatment of GERD In addition we want to measure standard outcomes such as morbidity mortality medication use and patient derived outcomes such as general and disease specific QOL and patient satisfaction with the treatment We also want to assess if and how long QOL is improved by medical and surgical treatment methods In addition we want to see if low QOL scores on medical treatment as well as the standard medical criteria can help to identify which patients may benefit from surgical an operation rather than the medical treatment It is hoped that we can also identify which factors might predict or help to determine which patients will have failure of both medical and surgical treatments of GERD Using this information we want to identify if a psychological profile done before treatment will influence or predict the outcomes of treatment
This studys goal is to build a database to collect the outcome information on patients who are having medical or surgical treatment of GERD In addition we want to measure standard outcomes such as morbidity mortality medication use and patient derived outcomes such as general and disease specific QOL and patient satisfaction with the treatment We also want to assess if and how long QOL is improved by medical and surgical treatment methods In addition we want to see if low QOL scores on medical treatment as well as the standard medical criteria can help to identify which patients may benefit from surgical an operation rather than the medical treatment It is hoped that we can also identify which factors might predict or help to determine which patients will have failure of both medical and surgical treatments of GERD Using this information we want to identify if a psychological profile done before treatment will influence or predict the outcomes of treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None