Mayo Clinic Foregut Surgery Report Card Questionnaire
|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: NCT02708303|
Recruitment Status : Recruiting
First Posted : March 15, 2016
Last Update Posted : August 17, 2018
|Condition or disease||Intervention/treatment|
|Gastroesophageal Reflux Fundoplication Hernia, Hiatal Surveys and Questionnaires||Other: Mayo Clinic Foregut Surgery Report Card Questionnaire|
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|Official Title:||Mayo Clinic Foregut Surgery Report Card Questionnaire|
|Actual Study Start Date :||March 17, 2016|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||March 2020|
Foregut surgery includes conditions of the esophagus, stomach and proximal small intestine. More specifically foregut surgery includes surgery for gastroesophageal reflux disease, hiatal hernias, and paraesophageal hernias.
Other: Mayo Clinic Foregut Surgery Report Card Questionnaire
Patients will be asked to complete the Mayo Clinic Foregut Surgery Report Card Questionnaire at approximately 8-10 weeks following surgery and then with each surveillance clinic visit or a minimum of once per year for their lifetime. The questionnaire can be completed at their clinic visit, over the telephone, or by mail. The patient's medical record will also be reviewed to gather any other contributing information.
Data collected from the questionnaire will be entered into a database that will be maintained for future research.
- Completion of the Mayo Clinic Foregut Surgery Report Card Questionnaires by patients at varying time points following surgery [ Time Frame: 1 year ]Completed Mayo Clinic Foregut Surgery Report Card Questionnaires will be analyzed and used to establish validation.
- Establishment of "normal" or expected scores from the Mayo Clinic Foregut Surgery Report Card Questionnaires [ Time Frame: 3 years ]Completed Mayo Clinic Foregut Surgery Report Card Questionnaires will be used in the establishment of "normal" or expected scores for patients undergoing each type of foregut surgery at different time points following surgery.
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): NCT02708303
|Contact: Karlyn Pierson, MAN, RNfirstname.lastname@example.org|
|Contact: Bettie Lechtenbergemail@example.com|
|United States, Minnesota|
|Mayo Clinic in Rochester||Recruiting|
|Rochester, Minnesota, United States, 55905|
|Contact: Karlyn Pierson, MAN, RN 507-538-1960 firstname.lastname@example.org|
|Contact: Bettie Lechtenberg 507-266-4819 email@example.com|
|Principal Investigator: Shanda Blackmon, MD, MPH, FACS|
|Principal Investigator:||Shanda Blackmon, MD, MPH, FACS||Mayo Clinic|