Assessing Outcomes After Surgery for Gastroesophageal Ref... | NCT00518505

Studies
Assessing Outcomes After Surgery for Gastroesophageal Reflux Disorder

NCT00518505

Sponsor

University of South Florida

Status

Unknown status

Last Update Posted

Aug 15, 2012Estimated

Enrollment

1,500Estimated

Phase

Not Applicable

Conditions

Gastroesophageal Reflux Disorder

Interventions

Symptom questionnaire

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2006

Primary Completion Date

Sep 2017Estimated

Completion Date

Sep 2017Estimated

First Submitted Date

Aug 16, 2007

First Submission Date that Met QC Criteria

Aug 17, 2007

First Posted Date

Aug 20, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 14, 2012

Last Update Posted Date

Aug 15, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Kenneth Luberice, Principal Investigator, University of South FloridaPrincipal Investigator

Lead Sponsor

University of South FloridaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
I	Other	This is a single arm study. All patients will be asked to complete questionnaires and have their medical charts reviewed.	Other: Symptom questionnaire

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Symptom questionnaire	Other	This questionnaire will assess patient outcomes before and after surgery for gastroesophageal reflux disorder.	I

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jennifer C Cooper, B.S.	Contact	813-844-4218	4218	jcooper@health.usf.edu
Carl B Bowers, R.N.	Contact	813-844-7529	7529	cowers@health.usf.edu

Overall Officials

Name	Affiliation	Role
Alexander S Rosemurgy, M.D.	University of South Florida	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tampa General Hospital/University of South Florida	Recruiting	Tampa	Florida	33606	United States

Condition Browse Module

MeSH Terms

ID	Term
D005764	Gastroesophageal Reflux

Ancestor Terms

ID	Term
D015154	Esophageal Motility Disorders
D003680	Deglutition Disorders
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided