The Impact of Biosynthetic Mesh on Paraesophageal Hernia Repair in Robotic Anti-Reflux Surgery: A Multi-Institutional Randomized Trial

Weill Medical College of Cornell University6 sites in 1 country200 target enrollmentJune 10, 2024

ConditionsHiatal Hernia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Hiatal Hernia
Sponsor: Weill Medical College of Cornell University
Enrollment: 200
Locations: 6
Primary Endpoint: Anatomic hiatal hernia recurrence rate
Status: Recruiting
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The aim of this study is to find out if using a certain kind of mesh can reduce the chances of hiatal hernias coming back after anti-reflux surgery. Participants undergoing antireflux surgery will be assigned to one of two groups, a group that has surgery with mesh, or a group that has surgery without mesh.

Registry

clinicaltrials.gov

Start Date

June 10, 2024

End Date

July 1, 2030

Last Updated

5 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Weill Medical College of Cornell University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Documented diagnosis of gastroesophageal reflux disease
•Adults aged 18 years or older
•English speaking
•Subject is planned to undergo surgery for reflux disease

Exclusion Criteria

•Physician deems the subject is unable to complete the study due to documented dementia.
•Subject is undergoing emergent surgery.
•Pregnancy
•Patient has known allergy to tetracycline hydrochloride or kanamycin sulfate

Outcomes

Primary Outcomes

Anatomic hiatal hernia recurrence rate

Time Frame: 1 year

Secondary Outcomes

Anatomic Hiatal Hernia Recurrence rate(5 years)
Reflux Symptoms(5 years postoperatively)
Number of subjects requiring reoperation(30 days following surgery)
Dysphagia Symptoms(5 years postoperatively)
Number of subjects requiring 30 day readmission(30 days following surgery)
Number of subjects developing postoperative Infection(30 days following surgery)