Mayo Clinic Foregut Surgery Report Card Questionnaire

NCT02708303 | Terminated

• 1 other identifier: 16-001151
• Study Type: observational
• Target: 274
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Completion of the Mayo Clinic Foregut Surgery Report Card Questionnaires by patients at varying time points following surgery

  Completed Mayo Clinic Foregut Surgery Report Card Questionnaires will be analyzed and used to establish validation.

  1 year

Secondary Outcomes (1)

• Establishment of "normal" or expected scores from the Mayo Clinic Foregut Surgery Report Card Questionnaires

  3 years

Study Arms (1)

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

Interventions

Mayo Clinic Foregut Surgery Report Card Questionnaire OTHER

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.

Foregut Surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing or having already undergone foregut surgery at Mayo Clinic Rochester.

* ≥ 18 years old * Scheduled to undergo Foregut surgery at Mayo Clinic Rochester which includes surgery for gastroesophageal reflux disease, hiatal hernias, and paraesophageal hernias.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Gastroesophageal Reflux; Hernia, Hiatal

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Hernia, Diaphragmatic; Internal Hernia; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Janani Reisenauer, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 9, 2016
• First Posted: March 15, 2016
• Study Start: March 17, 2016
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: March 22, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)