MedDataX Logo

Assessing Outcomes After Surgery for Gastroesophageal Reflux Disorder

NCT ID: NCT00518505

Last Updated: 2012-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2017-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gastroesophageal Reflux Disorder

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

GERD, laparoscopic surgery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

I

This is a single arm study. All patients will be asked to complete questionnaires and have their medical charts reviewed.

Group Type OTHER

Symptom questionnaire

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Symptom questionnaire

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* patients must have GERD and must plan to have laparoscopic surgery for GERD.
* patients must be at least 18 years of age
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of South Florida

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Kenneth Luberice

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Alexander S Rosemurgy, M.D.

Role: STUDY_DIRECTOR

University of South Florida

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Tampa General Hospital/University of South Florida

Tampa, Florida, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Jennifer C Cooper, B.S.

Role: CONTACT

Phone: 813-844-4218

Email: [email protected]

Carl B Bowers, R.N.

Role: CONTACT

Phone: 813-844-7529

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Jennifer C. Cooper, B.S.

Role: primary

Carl B Bowers, R.N.

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

105238

Identifier Type: -

Identifier Source: org_study_id