We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Assessing Outcomes After Surgery for Gastroesophageal Reflux Disorder (GERD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00518505
Recruitment Status : Unknown
Verified August 2012 by Kenneth Luberice, University of South Florida.
Recruitment status was:  Recruiting
First Posted : August 20, 2007
Last Update Posted : August 15, 2012
Sponsor:
Information provided by (Responsible Party):
Kenneth Luberice, University of South Florida

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.

Condition or disease Intervention/treatment
Gastroesophageal Reflux Disorder Other: Symptom questionnaire

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Long and Short Term Outcomes After Laparoscopic Surgery for Gastroesophageal Reflux Disease
Study Start Date : December 2006
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD
U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Kenneth Luberice, Principal Investigator, University of South Florida
ClinicalTrials.gov Identifier: NCT00518505     History of Changes
Other Study ID Numbers: 105238
First Posted: August 20, 2007    Key Record Dates
Last Update Posted: August 15, 2012
Last Verified: August 2012

Keywords provided by Kenneth Luberice, 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