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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00519220
Recruitment Status : Unknown
Verified August 2012 by Kenneth Luberice, University of South Florida.
Recruitment status was:  Recruiting
First Posted : August 22, 2007
Last Update Posted : August 15, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Achalasia Other: Symptom questionnaire

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 Design

Study Type : Observational
Estimated Enrollment : 800 participants
Official Title: Short and Long Term Outcomes of Heller Myotomy
Study Start Date : December 2006
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

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.


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients with achalasia who have had laparoscopic Heller myotomies at Tampa General Hospital.
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00519220


Contacts
Contact: Kenneth Luberice 813-844-8219 kluberic@mail.usf.edu
Contact: Carl B Bowers, RN 813-844-7529 ext 7529 cbowers@health.usf.edu

Locations
United States, Florida
Tampa General Hospital/University of South Florida Recruiting
Tampa, Florida, United States, 33606
Contact: Jennifer C. Cooper, B.S.    813-844-4218 ext 4218    jcooper@health.usf.edu   
Contact: Carl B Bowers, R.N.    813-844-7529 ext 7529    cbowers@health.usf.edu   
Sponsors and Collaborators
University of South Florida
Investigators
Principal Investigator: Alexander S Rosemurgy, MD University of South Florida
More Information

Responsible Party: Kenneth Luberice, Principal Investigator, University of South Florida
ClinicalTrials.gov Identifier: NCT00519220     History of Changes
Other Study ID Numbers: 105235
First Posted: August 22, 2007    Key Record Dates
Last Update Posted: August 15, 2012
Last Verified: August 2012

Keywords provided by Kenneth Luberice, University of South Florida:
achalasia, Heller myotomy

Additional relevant MeSH terms:
Esophageal Achalasia
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases