Trial Summary
What is the purpose of this trial?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.
Is the treatment called Biosynthetic Mesh a promising treatment for hiatal hernia?Yes, Biosynthetic Mesh is a promising treatment for hiatal hernia. It helps reduce the chance of the hernia coming back after surgery and does not significantly increase swallowing problems after the procedure.13679
What safety data is available for biosynthetic mesh used in hernia repair?The safety data for biosynthetic mesh, including Phasix™ Mesh and GORE BIO-A Tissue Reinforcement, indicates that these meshes are suitable for use in contaminated fields due to their resorbability and biocompatibility. Studies have shown that Phasix™ Mesh combines the benefits of biological and synthetic meshes, offering mechanical strength and reduced infection risk. Long-term performance data over 24 months for Phasix™ Mesh in hernia repair is available, and it has been used successfully in high-risk patients with satisfactory outcomes. Gore Bio-A has been used safely in contaminated fields and is considered a feasible alternative to traditional biologics for abdominal closure.24589
What data supports the idea that Biosynthetic Mesh for Hiatal Hernia is an effective treatment?The available research shows that using biosynthetic mesh for hiatal hernia repair can reduce the chance of the hernia coming back. One study found that using mesh in the repair of large hiatal hernias led to fewer recurrences compared to just stitching the area. Another study reported that using biosynthetic mesh did not lead to more swallowing problems after surgery, which is a common concern. Overall, these findings suggest that biosynthetic mesh is effective in making the repair last longer without adding extra complications.137910
Do I have to stop taking my current medications for this trial?The trial protocol does not specify whether you need to stop taking your current medications.
Eligibility Criteria
This trial is for individuals who are undergoing antireflux surgery due to hiatal hernias. Specific eligibility criteria details were not provided, so it's important to contact the study organizers for more information on who can participate.Inclusion Criteria
I have been diagnosed with acid reflux disease.
Exclusion Criteria
I am scheduled for emergency surgery.
Treatment Details
The study is testing if using biosynthetic mesh during hiatal hernia repair surgery can prevent the hernia from returning. Participants will be randomly placed in two groups: one receiving surgery with mesh and one without.
2Treatment groups
Experimental Treatment
Active Control
Group I: Biosynthetic MeshExperimental Treatment2 Interventions
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.
Group II: No MeshActive Control1 Intervention
The non-mesh group will undergo repair with permanent suture only.
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Research locations nearbySelect from list below to view details:
NYU Langone HealthNew York, NY
Lenox Hill HospitalNew York, NY
University of Southern California Keck School of MedicineLos Angeles, CA
Washington University School of MedicineSaint Louis, MO
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Who is running the clinical trial?
Weill Medical College of Cornell UniversityLead Sponsor
Intuitive SurgicalIndustry Sponsor
References
Paraesophageal hernia repair with biomesh does not increase postoperative dysphagia. [2022]Laparoscopic techniques have led to hiatal procedures being performed with less morbidity but higher failure rates. Biologic mesh (biomesh) has been proposed as an alternative to plastic mesh to achieve durable repairs while minimizing stricturing and erosion. This paper documents the lack of significant dysphagia after the placement of biomesh during hiatal hernia repair.
The use of Gore Bio-A in the management of the open abdomen. [2022]Non-permanent, non-woven options for the closure of an open abdomen have previously been limited to biologics such as Permacol or Strattice. Gore Bio-A is constructed from biocompatible synthetic fibres, the use of which has only been described in the repair of inguinal hernia, hiatal hernia and fistula-in-ano. A 60-year-old male underwent emergency laparotomy, partial gastrectomy and formation of a feeding jejunostomy for a strangulated and perforated intrathoracic hiatus hernia. His abdominal wall subsequently dehisced for which he underwent laparostomy and subsequent early closure with a Gore Bio-A mesh, secured in an onlay manner with 2/0 vicryl. Functional and cosmetic outcomes were satisfactory and the patient was discharged home. The use of Gore Bio-A is a safe, feasible and cost effective alternative to traditional biologics for the closure of a laparostomy, deployment of which is safe within a contaminated field. Further prospective data is needed to clarify its role.
Short-term results for laparoscopic repair of large paraesophageal hiatal hernias with Gore Bio A® mesh. [2022]The application of mesh-reinforced hiatal closure has resulted in a significant reduction in recurrence rates in comparison with primary suture repair. One of the most debated issues is the risk of complications related to the use of the prosthesis, such as esophageal erosion and postoperative dysphagia. The aim of this study is to present our short-terms results in the treatment of laparoscopic paraesophageal hiatal hernia (LPHH) with a synthetic polyglycolic acid:trimethylene carbonate mesh (Gore Bio A(®)).
Characterization of host response, resorption, and strength properties, and performance in the presence of bacteria for fully absorbable biomaterials for soft tissue repair. [2022]Label="PURPOSE">The objective was to evaluate the host response, resorption, and strength properties, and to assess the performance in the presence of bacteria for Phasix™ Mesh (Phasix™) and Gore® Bio-A® Tissue Reinforcement (Bio-A®) in preclinical models.
A post-market, prospective, multi-center, single-arm clinical investigation of Phasix™ mesh for VHWG grade 3 midline incisional hernia repair: a research protocol. [2019]Incisional heia is a frequent complication of midline laparotomy. The use of mesh in hernia repair has been reported to lead to fewer recurrences compared to primary repair. However, in Ventral Hernia Working Group (VHWG) Grade 3 hernia patients, whose hernia is potentially contaminated, synthetic mesh is prone to infection. There is a strong preference for resorbable biological mesh in contaminated fields, since it is more able to resist infection, and because it is fully resorbed, the chance of a foreign body reaction is reduced. However, when not crosslinked, biological resorbable mesh products tend to degrade too quickly to facilitate native cellular ingrowth. Phasix™ Mesh is a biosynthetic mesh with both the biocompatibility and resorbability of a biological mesh and the mechanical strength of a synthetic mesh. This multi-center single-arm study aims to collect data on safety and performance of Phasix™ Mesh in Grade 3 hernia patients.
When the Mesh Goes Away: An Analysis of Poly-4-Hydroxybutyrate Mesh for Complex Hernia Repair. [2022]Mesh reinforcement is a cornerstone of modern ventral hernia repair (VHR); yet, complications with synthetic mesh and cost of biologic have created a need for alternative options. Biosynthetic mesh is a resorbable scaffold that theoretically leverages the benefits and minimizes deficiencies of existing mesh types. This study evaluates 2-year outcomes following poly-4-hydroxybutyrate (P4HB) mesh reinforcement for complex VHR.
The use of biosynthetic mesh in giant hiatal hernia repair: is there a rationale? A 3-year single-center experience. [2021]Reinforced prosthetic crural repair is particularly indicated for giant hiatal hernias. The rationale is to reduce the recurrence rate in the long term. The aim of our study is to evaluate the outcomes of laparoscopic giant hiatal hernia repair using a biosynthetic mesh.
Outcomes of biosynthetic absorbable mesh use in high risk CDC Class I ventral hernia repair: a single surgeon series. [2022]Label="PURPOSE">Biosynthetic absorbable meshes have emerged as suitable alternatives to permanent synthetic and biologic meshes in complex ventral hernia repair in contaminated wounds. Evidence regarding the use of these products in clean wounds is currently scant. This paper presents a large single surgeon series using GORE®BIO-A® (W.L. Gore & Associates, Newark, DE) (Bio-A) tissue reinforcement in high risk patients with predominantly CDC Class I wounds.
Slowly resorbable biosynthetic mesh: 2-year results in VHWG grade 3 hernia repair. [2022]Information on the long-term performance of biosynthetic meshes is scarce. This study analyses the performance of biosynthetic mesh (Phasix™) over 24 months.
Hiatal hernia repair with biosynthetic mesh reinforcement: a qualitative systematic review. [2023]Reinforcement of crural closure with synthetic resorbable mesh has been proposed to decrease recurrence rates after hiatal hernia repair, but continues to be controversial. This systematic review aims to evaluate the safety, efficacy, and intermediate-term results of using biosynthetic mesh to augment the hiatus.