Impact of Biosynthetic Mesh on Paraesophageal Hernia Repair
- Conditions
- Hiatal Hernia
- Interventions
- Device: Biosynthetic MeshProcedure: Hiatal Hernia Repair
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- Documented diagnosis of gastroesophageal reflux disease
- Adults aged 18 years or older
- English speaking
- Subject is planned to undergo surgery for reflux disease
- 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
- Arm && Interventions
Group Intervention Description Biosynthetic Mesh Biosynthetic Mesh The biosynthetic mesh group will undergo hiatal hernia repair with Phasix Mesh (Becton Dickinson, Franklin Lakes, NJ) reinforcement, secured with permanent suture. This is a biosynthetic mesh that completely reabsorbs in 12-18 months after surgery. The mesh is designed to provide strength during the initial healing phase after hernia repair, allowing for rapid tissue ingrowth and vascularization, gradually transferring the load to native tissue as it resorbs1. This mesh has been FDA approved for procedures involving soft tissue repair, such as hernia defects. Biosynthetic Mesh Hiatal Hernia Repair The biosynthetic mesh group will undergo hiatal hernia repair with Phasix Mesh (Becton Dickinson, Franklin Lakes, NJ) reinforcement, secured with permanent suture. This is a biosynthetic mesh that completely reabsorbs in 12-18 months after surgery. The mesh is designed to provide strength during the initial healing phase after hernia repair, allowing for rapid tissue ingrowth and vascularization, gradually transferring the load to native tissue as it resorbs1. This mesh has been FDA approved for procedures involving soft tissue repair, such as hernia defects. No Mesh Hiatal Hernia Repair The non-mesh group will undergo repair with permanent suture only.
- Primary Outcome Measures
Name Time Method Anatomic hiatal hernia recurrence rate 1 year
- Secondary Outcome Measures
Name Time Method Anatomic Hiatal Hernia Recurrence rate 5 years 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
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