Clinical trial NCT02708303: Mayo Clinic Foregut Surgery Report Card Questionnaire
Official title: Mayo Clinic Foregut Surgery Report Card Questionnaire
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Gastroesophageal Reflux
Fundoplication
Hernia, Hiatal
Surveys and Questionnaires
Keywords: 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
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2016-03-15
Enrollment: 274
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing or having already undergone foregut surgery at Mayo Clinic Rochester.

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 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.

Eligibility 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.

Primary outcomes:
measure: Completion of the Mayo Clinic Foregut Surgery Report Card Questionnaires by patients at varying time points following surgery
timeFrame: 1 year
Secondary outcomes:
measure: Establishment of "normal" or expected scores from the Mayo Clinic Foregut Surgery Report Card Questionnaires
timeFrame: 3 years
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Janani Reisenauer, MD
role: PRINCIPAL_INVESTIGATOR
References: