Achalasia Patient Reported Outcomes
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02606578|
Recruitment Status : Recruiting
First Posted : November 17, 2015
Last Update Posted : January 9, 2018
|Condition or disease||Intervention/treatment|
|Esophageal Achalasia Achalasia Achalasia, Esophageal||Other: Questionnaires|
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Achalasia Patient Reported Outcomes|
|Study Start Date :||October 2015|
|Estimated Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||October 2019|
- Other: Questionnaires
The study team will collect information from your medical record regarding: demographics, operation, nutritional status, laboratory values, testing results, complications, hospital data, cost, length of stay, past medical history and clinical outcomes.
At your clinical follow-up visits (~4 weeks, 6 months, and 12 months post operation), a study coordinator will meet with you to assess for adverse events and to have you complete research questionnaires. Alternatively, the study coordinator may call you to assess for adverse events and ask if we can mail you the research questionnaires to complete and mail back.
You will also be asked to complete the research questionnaires a minimum of once a year for your lifetime: A study coordinator will call you and ask if we can mail you questionnaires to complete and mail back.
- Comparison of different surgical techniques with patient reported post-operative symptoms on the achalasia questionnaire [ Time Frame: 2 years ]Comparison of surgical techniques evaluated from the patient's medical record using patient reported post-operative symptoms on the achalasia questionnaire. The achalasia questionnaire includes quality of life, pain, activity level, heart burn, acid regurgitation, reflux, dysphagia, and diet.
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): NCT02606578
|Contact: Karlyn Pierson, RN, MANemail@example.com|
|Contact: Bettie Lechtenberg, MBAfirstname.lastname@example.org|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55901|
|Contact: Karlyn Pierson, MAN, RN 507-538-1960 email@example.com|
|Contact: Bettie Lechtenberg, MBA 507-266-4819 firstname.lastname@example.org|
|Principal Investigator: Shanda Blackmon, MD, MPH, FACS|
|Principal Investigator:||Shanda Blackmon, MD, MPH, FACS||Mayo Clinic|