Impact of Biosynthetic Mesh on Paraesophageal Hernia Repair
NCT ID: NCT06444347
Last Updated: 2025-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
200 participants
INTERVENTIONAL
2024-06-10
2030-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
The biosynthetic mesh group will undergo hiatal hernia repair with Phasix Mesh (Becton Dickinson, Franklin Lakes, NJ) reinforcement, secured with permanent suture.
Hiatal Hernia Repair
The non-mesh group will undergo hiatal hernia repair with permanent suture only.
No Mesh
The non-mesh group will undergo repair with permanent suture only.
Hiatal Hernia Repair
The non-mesh group will undergo hiatal hernia repair with permanent suture only.
Interventions
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Biosynthetic Mesh
The biosynthetic mesh group will undergo hiatal hernia repair with Phasix Mesh (Becton Dickinson, Franklin Lakes, NJ) reinforcement, secured with permanent suture.
Hiatal Hernia Repair
The non-mesh group will undergo hiatal hernia repair with permanent suture only.
Eligibility Criteria
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Inclusion Criteria
* Adults aged 18 years or older
* English speaking
* Subject is planned to undergo surgery for reflux disease
Exclusion Criteria
* Subject is undergoing emergent surgery.
* Pregnancy
* Patient has known allergy to tetracycline hydrochloride or kanamycin sulfate
18 Years
ALL
Yes
Sponsors
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Intuitive Surgical
INDUSTRY
Weill Medical College of Cornell University
OTHER
Responsible Party
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Principal Investigators
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Rasa Zarnegar, MD
Role: PRINCIPAL_INVESTIGATOR
Weill Medical College of Cornell University
Locations
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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
St Louis, Missouri, United States
NYU Langone Health
New York, New York, United States
Weill Cornell Medicine
New York, New York, United States
Lenox Hill Hospital
New York, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Luis Espinosa, MD
Role: primary
Mattia Ballo, MD
Role: primary
References
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Yamasaki T, Hemond C, Eisa M, Ganocy S, Fass R. The Changing Epidemiology of Gastroesophageal Reflux Disease: Are Patients Getting Younger? J Neurogastroenterol Motil. 2018 Oct 1;24(4):559-569. doi: 10.5056/jnm18140.
Li Q, Blume SW, Huang JC, Hammer M, Ganz ML. Prevalence and healthcare costs of obesity-related comorbidities: evidence from an electronic medical records system in the United States. J Med Econ. 2015;18(12):1020-8. doi: 10.3111/13696998.2015.1067623. Epub 2015 Sep 4.
Oelschlager BK, Pellegrini CA, Hunter JG, Brunt ML, Soper NJ, Sheppard BC, Polissar NL, Neradilek MB, Mitsumori LM, Rohrmann CA, Swanstrom LL. Biologic prosthesis to prevent recurrence after laparoscopic paraesophageal hernia repair: long-term follow-up from a multicenter, prospective, randomized trial. J Am Coll Surg. 2011 Oct;213(4):461-8. doi: 10.1016/j.jamcollsurg.2011.05.017. Epub 2011 Jun 29.
Spiro C, Quarmby N, Gananadha S. Mesh-related complications in paraoesophageal repair: a systematic review. Surg Endosc. 2020 Oct;34(10):4257-4280. doi: 10.1007/s00464-020-07723-0. Epub 2020 Jun 18.
Deeken CR, Matthews BD. Characterization of the Mechanical Strength, Resorption Properties, and Histologic Characteristics of a Fully Absorbable Material (Poly-4-hydroxybutyrate-PHASIX Mesh) in a Porcine Model of Hernia Repair. ISRN Surg. 2013 May 28;2013:238067. doi: 10.1155/2013/238067. Print 2013.
Alicuben ET, Worrell SG, DeMeester SR. Resorbable biosynthetic mesh for crural reinforcement during hiatal hernia repair. Am Surg. 2014 Oct;80(10):1030-3.
Aiolfi A, Cavalli M, Sozzi A, Lombardo F, Lanzaro A, Panizzo V, Bonitta G, Mendogni P, Bruni PG, Campanelli G, Bona D. Medium-term safety and efficacy profile of paraesophageal hernia repair with Phasix-ST(R) mesh: a single-institution experience. Hernia. 2022 Feb;26(1):279-286. doi: 10.1007/s10029-021-02528-z. Epub 2021 Oct 30.
Tartaglia E, Cuccurullo D, Guerriero L, Reggio S, Sagnelli C, Mugione P, Corcione F. The use of biosynthetic mesh in giant hiatal hernia repair: is there a rationale? A 3-year single-center experience. Hernia. 2021 Oct;25(5):1355-1361. doi: 10.1007/s10029-020-02273-9. Epub 2020 Jul 25.
Panici Tonucci T, Asti E, Sironi A, Ferrari D, Bonavina L. Safety and Efficacy of Crura Augmentation with Phasix ST Mesh for Large Hiatal Hernia: 3-Year Single-Center Experience. J Laparoendosc Adv Surg Tech A. 2020 Apr;30(4):369-372. doi: 10.1089/lap.2019.0726. Epub 2020 Jan 7.
Quake, S. Y. L., Peter, B., Munipalle, P. C., & Viswanath, Y. (2023). OGBN O08 The Safety and Efficacy of Laparoscopic Hiatus Hernia Repair with Biosynthetic Mesh (Phasix-ST®): A Single Centre Experience. British Journal of Surgery, 110(Supplement_8), znad348-030.
Konstantinidis H, Charisis C. Surgical treatment of large and complicated hiatal hernias with the new resorbable mesh with hydrogel barrier (Phasix ST): a preliminary study. J Robot Surg. 2023 Feb;17(1):141-146. doi: 10.1007/s11701-022-01406-9. Epub 2022 Apr 9.
Abdelmoaty WF, Dunst CM, Filicori F, Zihni AM, Davila-Bradley D, Reavis KM, Swanstrom LL, DeMeester SR. Combination of Surgical Technique and Bioresorbable Mesh Reinforcement of the Crural Repair Leads to Low Early Hernia Recurrence Rates with Laparoscopic Paraesophageal Hernia Repair. J Gastrointest Surg. 2020 Jul;24(7):1477-1481. doi: 10.1007/s11605-019-04358-y. Epub 2019 Aug 29.
Related Links
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Other Identifiers
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23-11026766
Identifier Type: -
Identifier Source: org_study_id
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