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Assessing Outcomes After Surgery for Gastroesophageal Reflux Disorder (GERD)

Primary Purpose

Gastroesophageal Reflux Disorder

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Symptom questionnaire
Sponsored by
University of South Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Gastroesophageal Reflux Disorder focused on measuring GERD, laparoscopic surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • patients must have GERD and must plan to have laparoscopic surgery for GERD.
  • patients must be at least 18 years of age

Sites / Locations

  • Tampa General Hospital/University of South FloridaRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

I

Arm Description

This is a single arm study. All patients will be asked to complete questionnaires and have their medical charts reviewed.

Outcomes

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.

Secondary Outcome Measures

Full Information

First Posted
August 16, 2007
Last Updated
August 14, 2012
Sponsor
University of South Florida
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1. Study Identification

Unique Protocol Identification Number
NCT00518505
Brief Title
Assessing Outcomes After Surgery for Gastroesophageal Reflux Disorder
Acronym
GERD
Official Title
Long and Short Term Outcomes After Laparoscopic Surgery for Gastroesophageal Reflux Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Unknown status
Study Start Date
December 2006 (undefined)
Primary Completion Date
September 2017 (Anticipated)
Study Completion Date
September 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of South Florida

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disorder
Keywords
GERD, laparoscopic surgery

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
I
Arm Type
Other
Arm Description
This is a single arm study. All patients will be asked to complete questionnaires and have their medical charts reviewed.
Intervention Type
Other
Intervention Name(s)
Symptom questionnaire
Intervention Description
This questionnaire will assess patient outcomes before and after surgery for gastroesophageal reflux disorder.
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer C Cooper, B.S.
Phone
813-844-4218
Ext
4218
Email
jcooper@health.usf.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Carl B Bowers, R.N.
Phone
813-844-7529
Ext
7529
Email
cowers@health.usf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander S Rosemurgy, M.D.
Organizational Affiliation
University of South Florida
Official's Role
Study Director
Facility Information:
Facility Name
Tampa General Hospital/University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer C. Cooper, B.S.
Phone
813-844-4218
Ext
4218
Email
jcooper@health.usf.edu
First Name & Middle Initial & Last Name & Degree
Carl B Bowers, R.N.
Phone
813-844-7529
Ext
7529
Email
cbowers@health.usf.edu

12. IPD Sharing Statement

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Assessing Outcomes After Surgery for Gastroesophageal Reflux Disorder

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