Mayo Clinic Foregut Surgery Report Card Questionnaire

Gastroesophageal Reflux Clinical Trial

Official title:

Mayo Clinic Foregut Surgery Report Card Questionnaire

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02708303
• Other study ID #: 16-001151
• Status: Terminated
• Start date: March 17, 2016
• Est. completion date: October 1, 2018

Study information

• Verified date: March 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 274
• Est. completion date: October 1, 2018
• Est. primary completion date: October 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

• = 18 years old

• Scheduled to undergo Foregut surgery at Mayo Clinic Rochester which includes surgery for gastroesophageal reflux disease, hiatal hernias, and paraesophageal hernias.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Completion of the Mayo Clinic Foregut Surgery Report Card Questionnaires by patients at varying time points following surgery	Completed Mayo Clinic Foregut Surgery Report Card Questionnaires will be analyzed and used to establish validation.	1 year
Secondary	Establishment of "normal" or expected scores from the Mayo Clinic Foregut Surgery Report Card Questionnaires	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.	3 years