AchalasiaAchalasiaNCT00519220
Outcome of Symptoms in Patients Undergoing a Heller Myotomy
An observational study of Achalasia, run by University of South Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Achalasia
- What is being tested?
- Symptom questionnaire
- How many people
- 800 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2006to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with achalasia who have had laparoscopic Heller myotomies at Tampa General Hospital.
Who may be able to join
- Patients with achalasia who have had laparoscopic Heller myotomies for the treatment of achalasia
Who cannot join
- No patients under the age of 18 will be included
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Tampa General Hospital/University of South Florida
Tampa, Florida, 33606
Jennifer C. Cooper, B.S., 813-844-4218 ext. 4218, jcooper@health.usf.edu
Carl B Bowers, R.N., 813-844-7529 ext. 7529, cbowers@health.usf.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Achalasia
- Being tested
- Symptom questionnaire
- Keywords
- achalasia, Heller myotomy
- Medical subject headings
- Esophageal Achalasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Symptom questionnaireOther
Patients will answer questionnaires evaluating their symptoms of achalasia.
| Study group | Role | What they receive |
|---|---|---|
| I | Patients will answer symptom questionnaires and have their charts reviewed for relevant medical information. Receives: Other: Symptom questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2007 (estimated)
- Study startDec 2006
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AchalasiaStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenneth Luberice, University of South Florida
- Investigators
- Alexander S Rosemurgy, MD, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00519220
- Sponsor's protocol ID
- 105235
- Acronym
- Achalasia
- Status last verified
- Aug 2012
- First submitted
- 21 Aug 2007
- Last updated
- 15 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short and Long Term Outcomes of Heller Myotomy
- ClinicalTrials.gov ID
- NCT00519220
- Acronym / sponsor ID
- Achalasia / 105235
- Conditions
- Achalasia
- Keywords
- achalasia, Heller myotomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- Dec 2006
- Study completion
- Dec 2017 (estimated)
- First posted
- 22 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| I | – | Other: Symptom questionnairePatients will answer symptom questionnaires and have their charts reviewed for relevant medical information. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with achalasia who have had laparoscopic Heller myotomies at Tampa General Hospital.
Key inclusion criteria (1 listed)
- Patients with achalasia who have had laparoscopic Heller myotomies for the treatment of achalasia
Key exclusion criteria (1 listed)
- No patients under the age of 18 will be included
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Symptom questionnairePatients will answer questionnaires evaluating their symptoms of achalasia. | Other | I |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2012.
Related trials for Achalasia
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingPhase 2
Full-thickness Versus Progressive Myotomy in Peroral Endoscopic Esophageal Myotomy in Achalasia: A Randomized Controlled Trial
Achalasia Cardia, Achalasia
RecruitingPhase 3
PREcision MEDicine In Achalasia (PREMEDIA)
Type I Achalasia, Type II Achalasia
RecruitingObservational study
PREcision MEDicine In Achalasia (PREMEDIA) - Cohort
Type III Achalasia, EGJ Outflow Obstruction With Spastic/Hypercontractile Features
RecruitingPhase 4
VZV in the Enteric Nervous System: Pathogenesis and Consequences
Achalasia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander S Rosemurgy, MD principal investigator
University of South Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Achalasia, run by University of South Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kenneth Luberice (813-844-8219, kluberic@mail.usf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2012.