A Study to Compare Patient Reported Outcomes in the Belsey Mark-IV and Nissen fundoplication Procedures in Patients with Large Hiatal Hernia

Overview

  • Study type

    Observational
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 17-004548
    Sponsor Protocol Number: 17-004548

About this study

The goal of this study is to compare the rate of recurrence of hiatal hernia in patients with large hiatal hernias who had the Belsey Mark-IV and Nissen fundoplication procedures.

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • Hiatal hernia repair for large hiatal hernia at the Mayo Clinic between 01/01/2002 to 01/01/2012.
  • Had either the Belsey Mark-IV procedure or laparoscopic nissen fundoplication.

Exclusion Criteria: 

  • Age less than 18

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Mark Allen, M.D.

Open for enrollment

Contact information:

Mark Allen M.D.

allen.mark@mayo.edu