Impact of Biosynthetic Mesh on Paraesophageal Hernia Repair

NCT06444347 | Recruiting DMC FDA Device

• 1 other identifier: 23-11026766
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 6

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.

Conditions

Hiatal Hernia

Outcome Measures

Primary Outcomes (1)

• Anatomic hiatal hernia recurrence rate

  1 year

Secondary Outcomes (19)

• Anatomic Hiatal Hernia Recurrence rate

  3 years

• Anatomic Hiatal Hernia Recurrence rate

  5 years

• Reflux Symptoms

  2 weeks postoperatively

• Reflux Symptoms

  6 months postoperatively

• Reflux Symptoms

  1 year postoperatively

Study Arms (2)

Biosynthetic Mesh

EXPERIMENTAL

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.

Device: Biosynthetic Mesh; Procedure: Hiatal Hernia Repair

No Mesh

ACTIVE COMPARATOR

The non-mesh group will undergo repair with permanent suture only.

Procedure: Hiatal Hernia Repair

Interventions

Biosynthetic Mesh DEVICE

The biosynthetic mesh group will undergo hiatal hernia repair with Phasix Mesh (Becton Dickinson, Franklin Lakes, NJ) reinforcement, secured with permanent suture.

Biosynthetic Mesh

Hiatal Hernia Repair PROCEDURE

The non-mesh group will undergo hiatal hernia repair with permanent suture only.

Biosynthetic Mesh; No Mesh

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Intuitive Surgical: collaborator

Study Sites (6)

University of Southern California Keck School of Medicine

Los Angeles, California, 90089, United States

WITHDRAWN

Louisiana State University School of Medicine

New Orleans, Louisiana, 70112, United States

WITHDRAWN

Washington University School of Medicine

St Louis, Missouri, 63110, United States

WITHDRAWN

NYU Langone Health

New York, New York, 10016, United States

NOT YET RECRUITING

Weill Cornell Medicine

New York, New York, 10065, United States

RECRUITING

Lenox Hill Hospital

New York, New York, 10075, United States

NOT YET RECRUITING

Related Publications (12)

• 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.

  PMID: 30347935 BACKGROUND

• 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.

  PMID: 26134917 BACKGROUND

• 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.

  PMID: 21715189 BACKGROUND

• 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.

  PMID: 32556700 BACKGROUND

• 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.

  PMID: 23781348 BACKGROUND

• Alicuben ET, Worrell SG, DeMeester SR. Resorbable biosynthetic mesh for crural reinforcement during hiatal hernia repair. Am Surg. 2014 Oct;80(10):1030-3.

  PMID: 25264654 BACKGROUND

• 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.

  PMID: 34716832 BACKGROUND

• 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.

  PMID: 32712835 BACKGROUND

• 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.

  PMID: 31910348 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 35397107 BACKGROUND

• 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.

  PMID: 31468330 BACKGROUND

Related Links

• "PhasixTM Mesh."

MeSH Terms

Conditions

Hernia, Hiatal

Condition Hierarchy (Ancestors)

Hernia, Diaphragmatic; Internal Hernia; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Rasa Zarnegar, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Annabel Endean, NP

CONTACT

646-962-5250; ant2028@med.cornell.edu

Niloufar Salehi, MD

CONTACT

nis4017@med.cornell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2024
• First Posted: June 5, 2024
• Study Start: June 10, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2030
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)