Assessing Outcomes After Surgery for Gastroesophageal Reflux Disorder (GERD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2012 by University of South Florida
Sponsor:
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
  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
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, see Learn About Clinical Studies.

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 July 23, 2014