Mayo Clinic Foregut Surgery Report Card Questionnaire

March 21, 2024 updated by: Janani S. Reisenauer, Mayo Clinic
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

274

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing or having already undergone foregut surgery at Mayo Clinic Rochester.

Description

  • ≥ 18 years old
  • Scheduled to undergo Foregut surgery at Mayo Clinic Rochester which includes surgery for gastroesophageal reflux disease, hiatal hernias, and paraesophageal hernias.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Foregut Surgery
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Janani Reisenauer, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 17, 2016

Primary Completion (Actual)

October 1, 2018

Study Completion (Actual)

October 1, 2018

Study Registration Dates

First Submitted

March 9, 2016

First Submitted That Met QC Criteria

March 9, 2016

First Posted (Estimated)

March 15, 2016

Study Record Updates

Last Update Posted (Actual)

March 22, 2024

Last Update Submitted That Met QC Criteria

March 21, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-001151

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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