NCT02708303

Mayo Clinic Foregut Surgery Report Card Questionnaire

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 274 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Gastroesophageal Reflux
• Fundoplication
• Hernia, Hiatal
• Surveys and Questionnaires

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-03-17
• Primary completion: 2018-10-01
• Completion: 2018-10-01
• First posted: 2016-03-15
• Last updated: 2024-03-22

Locations

1 site across 1 country: United States