Outcome of Symptoms in Patients Undergoing a Heller Myotomy (Achalasia)

August 14, 2012 updated by: Kenneth Luberice, University of South Florida

Short and Long Term Outcomes of Heller Myotomy

The objective of this study is to review studies and patient symptoms before and after laparoscopic Heller myotomy to assess outcomes following laparoscopic surgery for achalasia.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Patients will answer questionnaires before and after surgery to evaluate their symptoms of achalasia and will also have their charts reviewed for relevant medical information.

Study Type

Observational

Enrollment (Anticipated)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33606
        • Recruiting
        • Tampa General Hospital/University of South Florida
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with achalasia who have had laparoscopic Heller myotomies at Tampa General Hospital.

Description

Inclusion Criteria:

  • Patients with achalasia who have had laparoscopic Heller myotomies for the treatment of achalasia

Exclusion Criteria:

  • No patients under the age of 18 will be included

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
I
Patients will answer symptom questionnaires and have their charts reviewed for relevant medical information.
Other: Symptom questionnaire
Patients will answer questionnaires evaluating their symptoms of achalasia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The objective of this study is to review pre-operative and post-operative studies and patient evaluation reports to evaluate patient outcomes following laparoscopic surgery for achalasia
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of South Florida

Investigators

  • Principal Investigator: Alexander S Rosemurgy, MD, University of South Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

August 21, 2007

First Submitted That Met QC Criteria

August 21, 2007

First Posted (Estimate)

August 22, 2007

Study Record Updates

Last Update Posted (Estimate)

August 15, 2012

Last Update Submitted That Met QC Criteria

August 14, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 105235

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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