Assessing Outcomes After Surgery for Gastroesophageal Reflux Disorder

Gastroesophageal Reflux Disorder Clinical Trial

— GERD  

Official title:

Long and Short Term Outcomes After Laparoscopic Surgery for Gastroesophageal Reflux Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00518505
• Other study ID #: 105238
• Status: Recruiting
• Phase: N/A
• First received: August 16, 2007
• Last updated: August 14, 2012
• Start date: December 2006
• Est. completion date: September 2017

Study information

• Verified date: August 2012
• Source: University of South Florida
• Contact: Jennifer C Cooper, B.S.
• Phone: 813-844-4218
• Email: jcooper[@]health.usf.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients must have GERD and must plan to have laparoscopic surgery for GERD.

• patients must be at least 18 years of age

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disorder

Intervention

Other:
• Symptom questionnaire
This questionnaire will assess patient outcomes before and after surgery for gastroesophageal reflux disorder.

Locations

Country	Name	City	State
United States	Tampa General Hospital/University of South Florida	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of South Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		5 years	No