Mayo Clinic Upper Digestive Disease Survey (UDD)

The Mayo Clinic Conduit Report Card Questionnaires have been created in order to have a consistent evaluation tools for patients undergoing esophageal reconstruction or treatment or patients that are experiencing an upper digestive disease in order to standardize and validate outcome measures. Data will be used to establish the validation of the questionnaires/survey. Data will also lead to the establishment of "normal" or expected scores for patients undergoing each type of esophagectomy procedure and for upper digestive diseases. Data will contribute to creating treatment algorithms for symptom management for upper digestive diseases and for post-operative complications and symptoms as well as contribute to pre-operative education.

Study Overview

• Status: Recruiting
• Conditions: Esophageal Cancer; Esophageal Neoplasms; Cancer of the Esophagus; Digestive System Abnormalities; Esophagus Cancer; Cancer of Esophagus; Esophagectomy; Neoplasm, Esophageal; Abnormalities, Digestive System
• Intervention / Treatment: Other: Mayo Clinic Upper Digestive Disease Survey on Paper; Other: Upper Digestive Disease (UDD Monitor) App

Detailed Description

The Mayo Clinic Conduit Report Card Questionnaires are a compilation of standard questionnaires and questions that have been created specifically for this study some of which are patient report and others that are administered by the provider or study staff. It includes the Promis Global Health Score, modified Mayo GER Score questions, modified Dysphagia Questionnaire-30 Day questions, and Zubrod Score. It also includes a 10-point scale to grade postoperative pain, milk assessment, Modified Mayo Reflux Score adapted from the Mayo Clinic Reflux Score, Dumping Score adapted from Sigstad's Scoring System, Simple Dysphagia Score adapted from Mellows and Pinkas, Stricture Score adapted from Blackmon, et al., Pyloric Spasm Score, and Conduit Emptying Score abstracted from Vaezi, Baker, Achkar, and Richter. We will also be collecting information on their demographics, operation, nutritional status, laboratory values, testing results and clinical outcomes.

Patients will be asked to complete the Mayo Clinic Upper Digestive Disease Survey at their one month surgical follow up visit and then every three months for 1 year after surgery, then with each surveillance clinic visit or a minimum of once per year for their lifetime for patients who undergo surgery and at one month following diagnosis and then every three months for 1 year after diagnosis, then with each surveillance clinic visit or a minimum of once per year for their lifetime for patients that do not undergo surgery. The questionnaire can be completed at their clinic visit, over the telephone, or by mail using the paper form or may be completed using an electronic application. The electronic version is available for Mayo Clinic and non Mayo Clinic patients through the app store in conjunction Mayo IT.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Mohamad Khair Abou Chaar, MD; Phone Number: 507-422-9936; Email: AbouChaar.MohamadKhairM@mayo.edu
• Study Contact Backup: Name: Karlyn Pierson, MAN, RN; Phone Number: 507-538-1960; Email: pierson.karlyn@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55901
      • Recruiting
      • Mayo Clinic
      • Contact: Karlyn Pierson, MAN, RN; Phone Number: 507-538-1960; Email: pierson.karlyn@mayo.edu

Participation Criteria

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 an esophagectomy or esophageal reconstruction.

Description

Inclusion Criteria:

• Patients undergoing or having already undergone an esophagectomy or esophageal reconstruction.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Esophagectomy/Esophageal Reconstruction/Treatment; Patients who have undergone esophagectomy, esophageal reconstruction, or treatment	Other: Mayo Clinic Upper Digestive Disease Survey on Paper; Mayo Clinic patients will be asked to complete the Mayo Clinic Upper Digestive Disease Survey at their one month surgical follow up visit and then every three months for 1 year after surgery, 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.; Other: Upper Digestive Disease (UDD Monitor) App; Mayo Clinic and non Mayo Clinic patients can participate by loading the app through the app store. Patient consent will be completed in the app. Patients will be asked to complete questionnaires at their 1.5 month surgical or diagnosis follow up and then every three months for 1 year after their surgery or diagnosis, then with each surveillance clinic visit or a minimum of once per year for their lifetime or as long as they want to participate. for iOS: https://apps.apple.com/us/app/upper-digestive-disease/id6448756724 for Android: https://play.google.com/store/apps/details?id=com.mayoclinic.uddmobile&pli=1
Upper Digestive Disease; Patients who have an upper digestive disease.	Other: Mayo Clinic Upper Digestive Disease Survey on Paper; Mayo Clinic patients will be asked to complete the Mayo Clinic Upper Digestive Disease Survey at their one month surgical follow up visit and then every three months for 1 year after surgery, 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.; Other: Upper Digestive Disease (UDD Monitor) App; Mayo Clinic and non Mayo Clinic patients can participate by loading the app through the app store. Patient consent will be completed in the app. Patients will be asked to complete questionnaires at their 1.5 month surgical or diagnosis follow up and then every three months for 1 year after their surgery or diagnosis, then with each surveillance clinic visit or a minimum of once per year for their lifetime or as long as they want to participate. for iOS: https://apps.apple.com/us/app/upper-digestive-disease/id6448756724 for Android: https://play.google.com/store/apps/details?id=com.mayoclinic.uddmobile&pli=1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Completion of the Mayo Clinic Upper Digestive Disease Survey by patients at varying time points following surgery	Completed Mayo Clinic Upper Digestive Disease Survey 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 Upper Digestive Disease Survey	Completed Mayo Clinic Upper Digestive Disease Survey will be used in the establishment of "normal" or expected scores for patients undergoing each type of esophagectomy procedure at different time points following surgery.	3 years

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Luis Tapias Vargas, MD, Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2015
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: August 18, 2015
• First Submitted That Met QC Criteria: August 20, 2015
• First Posted (Estimated): August 21, 2015

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Esophageal Neoplasms; Digestive System Abnormalities; Amino Acids, Peptides, and Proteins; Proteins; Macromolecular Substances; Multiprotein Complexes; Amyloid
• Other Study ID Numbers: 14-009873

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO