UDD: Mayo Clinic Upper Digestive Disease Survey
Study Details
Study Description
Brief Summary
The Mayo Clinic Conduit Report Card Questionnaires have been created in order to have a consistent evaluation tools for patients undergoing esophagectomy or esophageal reconstruction in order to standardize and validate outcome measures. Data will be used to establish the validation of the Mayo Clinic Conduit Report Card Questionnaires. Data will also lead to the establishment of "normal" or expected scores for patients undergoing each type of esophagectomy procedure
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 Conduit Report Card Questionnaires 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Esophagectomy/Esophageal Reconstruction Patients who have undergone esophagectomy or esophageal reconstruction |
Other: Mayo Clinic Conduit Report Card Questionnaires
Patients will be asked to complete the Mayo Clinic Conduit Report Card Questionnaires 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.
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Outcome Measures
Primary Outcome Measures
- Completion of the Mayo Clinic Conduit Report Card Questionnaires by patients at varying time points following surgery [1 year]
Completed Mayo Clinic Conduit Report Card Questionnaires will be analyzed and used to establish validation.
Secondary Outcome Measures
- Establishment of "normal" or expected scores from the Mayo Clinic Conduit Report Card Questionnaires [3 years]
Completed Mayo Clinic Conduit Report Card Questionnaires 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Patients undergoing or having already undergone an esophagectomy or esophageal reconstruction.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic | Rochester | Minnesota | United States | 55901 |
Sponsors and Collaborators
- Mayo Clinic
Investigators
- Principal Investigator: Shanda Blackmon, MD, MPH, FACS, Mayo Clinic
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 14-009873