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Recruiting NCT06444347

Impact of Biosynthetic Mesh on Paraesophageal Hernia Repair

No phase Interventional Hiatal Hernia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Biosynthetic Mesh, Hiatal Hernia Repair.
Who it may be relevant to
Registry conditions: Hiatal Hernia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The Impact of Biosynthetic Mesh on Paraesophageal Hernia Repair in Robotic Anti-Reflux Surgery: A Multi-Institutional Randomized Trial

Overview

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.

Interventions

  • Device Biosynthetic Mesh
    The biosynthetic mesh group will undergo hiatal hernia repair with Phasix Mesh (Becton Dickinson, Franklin Lakes, NJ) reinforcement, secured with permanent suture.
  • Procedure Hiatal Hernia Repair
    The non-mesh group will undergo hiatal hernia repair with permanent suture only.

Primary outcome measures

  • Anatomic hiatal hernia recurrence rate [Time frame: 1 year]
Secondary outcome measures (12)
  • Anatomic Hiatal Hernia Recurrence rate [Time frame: 3 years]
  • Anatomic Hiatal Hernia Recurrence rate [Time frame: 5 years]
  • Reflux Symptoms [Time frame: 2 weeks postoperatively]
  • Reflux Symptoms [Time frame: 6 months postoperatively]
  • Reflux Symptoms [Time frame: 1 year postoperatively]
  • Reflux Symptoms [Time frame: 2 years postoperatively]
  • Reflux Symptoms [Time frame: 3 years postoperatively]
  • Reflux Symptoms [Time frame: 4 years postoperatively]
  • Reflux Symptoms [Time frame: 5 years postoperatively]
  • Dysphagia Symptoms [Time frame: 2 weeks postoperatively]
  • Dysphagia Symptoms [Time frame: 6 months postoperatively]
  • Dysphagia Symptoms [Time frame: 1 year postoperatively]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 6 centers
  • University of Southern California Keck School of Medicine — Los Angeles
  • Louisiana State University School of Medicine — New Orleans
  • Washington University School of Medicine — St Louis
  • NYU Langone Health — New York
  • Weill Cornell Medicine — New York
  • Lenox Hill Hospital — New York

Publications

  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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

Identifiers

NCT: NCT06444347 · 23-11026766

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗