Impact of Biosynthetic Mesh on Paraesophageal Hernia Repair

Not Applicable

Recruiting

• Conditions: Hiatal Hernia

• Registration Number: NCT06444347
• Lead Sponsor: Weill Medical College of Cornell University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-30
• Study First Submitted QC: 2024-05-30
• Study First Posted: 2024-06-05
• Study Start: 2024-06-10
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-02
• Last Update Posted: 2024-12-03
• Primary Completion: 2026-07
• Study Completion: 2030-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Anatomic hiatal hernia recurrence rate	1 year

Secondary Outcome Measures

Name	Time	Method
Reflux Symptoms	5 years postoperatively	Reflux symptoms will be assessed using the gastroesophageal reflux disease health related quality of life survey (GERD-HRQL). The highest possible score on this survey is 75, indicating daily incapacitating symptoms in all areas assessed. The lowest possible score is 0, indicating no symptoms.
Number of subjects requiring reoperation	30 days following surgery
Dysphagia Symptoms	5 years postoperatively	Dysphagia symptoms will be assessed using the Bazaz dysphagia score. The lowest dysphagia severity score being "none", indicating no difficulty swallowing. The highest dysphagia severity score being "severe", indicating frequent difficulty swallowing with the majority of foods.
Number of subjects requiring 30 day readmission	30 days following surgery
Number of subjects developing postoperative Infection	30 days following surgery
Anatomic Hiatal Hernia Recurrence rate	5 years

Trial Locations

Locations (6)

Lenox Hill Hospital; 🇺🇸 New York, New York, United States

University of Southern California Keck School of Medicine; 🇺🇸 Los Angeles, California, United States

Louisiana State University School of Medicine; 🇺🇸 New Orleans, Louisiana, United States

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States

NYU Langone Health; 🇺🇸 New York, New York, United States

Weill Cornell Medicine; 🇺🇸 New York, New York, United States