NCT00518505

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 20, 2007

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

August 15, 2012

Status Verified

August 1, 2012

Enrollment Period

10.8 years

First QC Date

August 16, 2007

Last Update Submit

August 14, 2012

Conditions

Gastroesophageal Reflux Disorder

Keywords

GERD, laparoscopic surgery

Outcome Measures

Primary Outcomes (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.

    5 years

Study Arms (1)

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

Symptom questionnaireOTHER

This questionnaire will assess patient outcomes before and after surgery for gastroesophageal reflux disorder.

I

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tampa General Hospital/University of South Florida

Tampa, Florida, 33606, United States

RECRUITING

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Alexander S Rosemurgy, M.D.

    University of South Florida

    STUDY DIRECTOR

Central Study Contacts

Jennifer C Cooper, B.S.

CONTACT

813-844-4218jcooper@health.usf.edu

Carl B Bowers, R.N.

CONTACT

813-844-7529cowers@health.usf.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 16, 2007

First Posted

August 20, 2007

Study Start

December 1, 2006

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

August 15, 2012

Record last verified: 2012-08

Locations

US(1)