A Study to Compare Patient Reported Outcomes in the Belsey Mark-IV and Nissen fundoplication Procedures in Patients with Large Hiatal Hernia
Overview
Tab Title Description
Study type
ObservationalDescribes 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.
Study IDs
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. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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:
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Mark Allen, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available