Clinical Trial: Mayo Clinic Foregut Surgery Report Card Questionnaire

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Mayo Clinic Foregut Surgery Report Card Questionnaire

Brief Summary: The Mayo Clinic Foregut Surgery Report Card Questionnaire has been created in order to have a consistent evaluation tool for patients undergoing foregut surgery in order to standardize and validate outcome measures.

Detailed Summary: 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. Patients undergoing foregut surgery report having varying degrees of symptoms of reflux, regurgitation, dysphagia, and pain following surgery. Providers also note varying degrees of outcomes. Some of these issues can be assessed using pH probe testing, upper GI endoscopy, high resolution manometry, CT scans, and other testing. There are various validated questionnaires that have been used to assess problem areas of reflux, dysphagia, and pain such as the Promis Global Health Score, Mayo GER Score, Modified Dysphagia Questionnaire-30 Day, Zubrod Score, and pain scale. Each of these symptoms, tests, and questionnaires contributes to the provider's understanding of the patient's outcomes but there is currently no assessment tool that brings all of the test findings and information reported by the patient as symptoms or answers to the questionnaires in a format that that is usable for the clinician and understandable for the patient who has specifically undergone foregut surgery. The Mayo Clinic Foregut Surgery Report Card Questionnaire has been created in order to have a consistent evaluation tool for patients undergoing surgery in the foregut in order to standardize and validate outcome measures. Data will be used to establish the validation of the Mayo Clinic Foregut Surgery Report Card Questionnaire. Data will also lead to the establishment of "normal" or expected scores for patients undergoing each type of foregut procedure.
Sponsor: Mayo Clinic

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: 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.


Original Secondary Outcome: Same as current

Information By: Mayo Clinic

Dates:
Date Received: March 9, 2016
Date Started: March 2016
Date Completion:
Last Updated: December 20, 2016
Last Verified: December 2016