Clinical trial NCT02530983: Mayo Clinic Upper Digestive Disease Survey
Official title: Mayo Clinic Upper Digestive Disease Survey
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Esophageal Neoplasms
Cancer of Esophagus
Cancer of the Esophagus
Esophageal Cancer
Esophagus Cancer
Neoplasm, Esophageal
Esophagectomy
Abnormalities, Digestive System
Digestive System Abnormalities
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2015-08-21
Enrollment: 1000
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 an esophagectomy or esophageal reconstruction.

Brief summary: 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.

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.

Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
measure: Completion of the Mayo Clinic Upper Digestive Disease Survey by patients at varying time points following surgery
timeFrame: 1 year
Secondary outcomes:
measure: Establishment of "normal" or expected scores from the Mayo Clinic Upper Digestive Disease Survey
timeFrame: 3 years
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Luis Tapias Vargas, MD
role: PRINCIPAL_INVESTIGATOR
References: