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RecruitingNCT06444347Updated Aug 19, 2026

Impact of Biosynthetic Mesh on Paraesophageal Hernia Repair

An interventional study of Biosynthetic Mesh and Hiatal Hernia Repair in Hiatal Hernia, sponsored by Weill Medical College of Cornell University. Recruiting at 6 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-19.

Sponsored by Weill Medical College of Cornell University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2024; still recruiting 2 years 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Hiatal Hernia

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03

In context

Hernia, Hiatal

87 studies on the registry are indexed under Hernia, Hiatal; 27 are open to participants now.

This study's planned enrollment of 200 is above the median of 100 across 56 interventional studies indexed under Hernia, Hiatal.

Browse Hernia, Hiatal studies →

Lead sponsor

Weill Medical College of Cornell University is the lead sponsor of 892 studies on the registry; 165 are open to participants now.

Of its 123 completed or terminated interventional studies of FDA-regulated products, 94 (76%) have results posted.

Browse Weill Medical College of Cornell University studies →

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    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.

    Device: Biosynthetic Mesh · Procedure: Hiatal Hernia Repair

  • Active comparator
    No Mesh

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

    Procedure: Hiatal Hernia Repair

Interventions

  • DeviceBiosynthetic Mesh

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

  • ProcedureHiatal Hernia Repair

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

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What researchers measure

Primary outcomes

  1. Anatomic hiatal hernia recurrence rate

    Time frame: 1 year

Secondary outcomes

  1. Anatomic Hiatal Hernia Recurrence rate

    Time frame: 3 years

  2. Anatomic Hiatal Hernia Recurrence rate

    Time frame: 5 years

  3. Reflux Symptoms

    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.

    Time frame: 2 weeks postoperatively

  4. Reflux Symptoms

    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.

    Time frame: 6 months postoperatively

  5. Reflux Symptoms

    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.

    Time frame: 1 year postoperatively

  6. Reflux Symptoms

    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.

    Time frame: 2 years postoperatively

  7. Reflux Symptoms

    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.

    Time frame: 3 years postoperatively

  8. Reflux Symptoms

    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.

    Time frame: 4 years postoperatively

  9. Reflux Symptoms

    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.

    Time frame: 5 years postoperatively

  10. Dysphagia Symptoms

    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.

    Time frame: 2 weeks postoperatively

  11. Dysphagia Symptoms

    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.

    Time frame: 6 months postoperatively

  12. Dysphagia Symptoms

    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.

    Time frame: 1 year postoperatively

  13. Dysphagia Symptoms

    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.

    Time frame: 2 years postoperatively

  14. Dysphagia Symptoms

    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.

    Time frame: 3 years postoperatively

  15. Dysphagia Symptoms

    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.

    Time frame: 4 years postoperatively

  16. Dysphagia Symptoms

    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.

    Time frame: 5 years postoperatively

  17. Number of subjects requiring 30 day readmission

    Time frame: 30 days following surgery

  18. Number of subjects requiring reoperation

    Time frame: 30 days following surgery

  19. Number of subjects developing postoperative Infection

    Time frame: 30 days following surgery

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Study locations

1 of 6 sites recruiting
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References and documents

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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 32712835 ↗
  • 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. PubMed 31910348 ↗
  • 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. PubMed 35397107 ↗
  • 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. PubMed 31468330 ↗

Individual participant data

Plan to share: No

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2024 (actual). Primary completion is estimated for Jul 2027, 37 months after the start.

Of 33 interventional studies with no phase under Hernia, Hiatal, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 68. This study's planned 37 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
May 30, 2024
First posted
Jun 5, 2024
StartActual
Jun 10, 2024
Primary completionEst.
Jul 2027
CompletionEst.
Jul 2030
Last update
Aug 19, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06444347
Lead sponsor
Weill Medical College of Cornell University
Collaborators
Intuitive Surgical
Responsible party
Sponsor
First posted
Jun 5, 2024
Start date
Jun 10, 2024
Primary completion
Jul 2027 (estimated)
Completion
Jul 2030 (estimated)
Last update
Aug 19, 2026

Study contacts

Annabel Endean, NP
Contact
ant2028@med.cornell.edu
646-962-5250
Niloufar Salehi, MD
Contact
nis4017@med.cornell.edu
Rasa Zarnegar, MD
principal investigator · Weill Medical College of Cornell University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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