Outcome of Symptoms in Patients Undergoing a Heller Myotomy (Achalasia)
This study is currently recruiting participants.
Verified August 2012 by University of South Florida
Sponsor:
University of South Florida
Information provided by (Responsible Party):
Kenneth Luberice, University of South Florida
ClinicalTrials.gov Identifier:
NCT00519220
First received: August 21, 2007
Last updated: August 14, 2012
Last verified: August 2012
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Purpose
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 | Intervention |
|---|---|
|
Achalasia |
Other: Symptom questionnaire |
| Study Type: | Observational |
| Official Title: | Short and Long Term Outcomes of Heller Myotomy |
Further study details as provided by University of South Florida:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 800 |
| Study Start Date: | December 2006 |
| Estimated Study Completion Date: | December 2017 |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: 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
No publications provided
| Responsible Party: | Kenneth Luberice, Principal Investigator, University of South Florida |
| ClinicalTrials.gov Identifier: | NCT00519220 History of Changes |
| Other Study ID Numbers: | 105235 |
| Study First Received: | August 21, 2007 |
| Last Updated: | August 14, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by 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 |
ClinicalTrials.gov processed this record on May 19, 2013