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
| Tracking Information | |||||||||
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| First Received Date ICMJE | August 21, 2007 | ||||||||
| Last Updated Date | August 14, 2012 | ||||||||
| Start Date ICMJE | December 2006 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||||||
| Original Primary Outcome Measures ICMJE |
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 ] | ||||||||
| Change History | Complete list of historical versions of study NCT00519220 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Outcome of Symptoms in Patients Undergoing a Heller Myotomy | ||||||||
| Official Title ICMJE | Short and Long Term Outcomes of Heller Myotomy | ||||||||
| 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Not Provided | ||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Probability Sample | ||||||||
| Study Population | Patients with achalasia who have had laparoscopic Heller myotomies at Tampa General Hospital. |
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| Condition ICMJE | Achalasia | ||||||||
| Intervention ICMJE | Other: Symptom questionnaire
Patients will answer questionnaires evaluating their symptoms of achalasia. |
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| Study Group/Cohort (s) | I
Patients will answer symptom questionnaires and have their charts reviewed for relevant medical information.
Intervention: Other: Symptom questionnaire |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 800 | ||||||||
| Estimated Completion Date | December 2017 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00519220 | ||||||||
| Other Study ID Numbers ICMJE | 105235 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Kenneth Luberice, University of South Florida | ||||||||
| Study Sponsor ICMJE | University of South Florida | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of South Florida | ||||||||
| Verification Date | August 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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