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Mayo Clinic Foregut Surgery Report Card Questionnaire

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ClinicalTrials.gov Identifier: NCT02708303
Recruitment Status : Recruiting
First Posted : March 15, 2016
Last Update Posted : January 9, 2018
Sponsor:
Information provided by (Responsible Party):
Shanda Blackmon, M.D., M.P.H., Mayo Clinic

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.

Condition or disease Intervention/treatment
Gastroesophageal Reflux Fundoplication Hernia, Hiatal Surveys and Questionnaires Other: Mayo Clinic Foregut Surgery Report Card Questionnaire

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
Estimated Enrollment : 1000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Mayo Clinic Foregut Surgery Report Card Questionnaire
Actual Study Start Date : March 17, 2016
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2018

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.





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing or having already undergone foregut surgery at Mayo Clinic Rochester.
Criteria
  • ≥ 18 years old
  • Scheduled to undergo Foregut surgery at Mayo Clinic Rochester which includes surgery for gastroesophageal reflux disease, hiatal hernias, and paraesophageal hernias.

Information from the National Library of Medicine

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


Contacts
Contact: Karlyn Pierson, MAN, RN 507-538-1960 pierson.karlyn@mayo.edu
Contact: Bettie Lechtenberg 507-266-4819 lechtenberg.bettie@mayo.edu

Locations
United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Karlyn Pierson, MAN, RN    507-538-1960    pierson.karlyn@mayo.edu   
Contact: Bettie Lechtenberg    507-266-4819    lechtenberg.bettie@mayo.edu   
Principal Investigator: Shanda Blackmon, MD, MPH, FACS         
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Shanda Blackmon, MD, MPH, FACS Mayo Clinic

Responsible Party: Shanda Blackmon, M.D., M.P.H., Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02708303     History of Changes
Other Study ID Numbers: 16-001151
First Posted: March 15, 2016    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Shanda Blackmon, M.D., M.P.H., Mayo Clinic:
Esophageal Reflux
Gastric Acid Reflux
Gastric Acid Reflux Disease
Gastro-Esophageal Reflux
Gastro-oesophageal Reflux
Gastroesophageal Reflux Disease
Reflux, Gastroesophageal
Esophageal Hernia
Hernia, Esophageal
Hernia, Paraesophageal
Hiatal Hernia
Sliding Hiatal Hernia
Sliding Esophageal Hernia
Hernia, Hiatus
Paraesophageal Hiatal Hernia
Questionnaires

Additional relevant MeSH terms:
Hernia
Gastroesophageal Reflux
Hernia, Hiatal
Pathological Conditions, Anatomical
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Hernia, Diaphragmatic