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Hiatal HerniaNCT06444347

Impact of Biosynthetic Mesh on Paraesophageal Hernia Repair

A study testing Biosynthetic Mesh and Hiatal Hernia Repair in people with Hiatal Hernia, run by Weill Medical College of Cornell University at 6 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Hiatal Hernia
What is being tested?
Biosynthetic Mesh and Hiatal Hernia Repair
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
6 sitesUnited States
Study dates
10 Jun 2024to Jul 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Annabel Endean, NP contact

646-962-5250

ant2028@med.cornell.edu

Niloufar Salehi, MD contact

nis4017@med.cornell.edu

6 sites in 1 country

United States6 sites, 3 recruiting

  • University of Southern California Keck School of Medicine

    Los Angeles, California, 90089

    Withdrawn

  • Louisiana State University School of Medicine

    New Orleans, Louisiana, 70112

    Withdrawn

  • NYU Langone Health

    New York, New York, 10016

    Luis Espinosa, MD

    Tanuja Damani, MD

    Not yet recruiting

  • Weill Cornell Medicine

    New York, New York, 10065

    Annabel Endean, NP, 646-962-5250, ant2028@med.cornell.edu

    Niloufar Salehi, MD, 212-746-5187, nis4017@med.cornell.edu

    Recruiting

  • Lenox Hill Hospital

    New York, New York, 10075

    Mattia Ballo, MD

    Filippo Filicori, MD

    Not yet recruiting

  • Washington University School of Medicine

    St Louis, Missouri, 63110

    Withdrawn

Other trials in United States

About this study

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

Conditions
Hiatal Hernia
Being tested
Biosynthetic Mesh, Hiatal Hernia Repair
Medical subject headings
Hernia, Hiatal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biosynthetic MeshDevice

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

  • Hiatal Hernia RepairProcedure or surgery

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

Study groups in NCT06444347
Study groupRoleWhat they receive
Biosynthetic MeshExperimentalThe 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.
Receives: Device: Biosynthetic Mesh; Procedure: Hiatal Hernia Repair
No MeshActive comparatorThe non-mesh group will undergo repair with permanent suture only.
Receives: Procedure: Hiatal Hernia Repair

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Anatomic hiatal hernia recurrence rate

    Measured: 1 year

Secondary outcomes (19)

  1. Anatomic Hiatal Hernia Recurrence rate

    Measured: 3 years

  2. Anatomic Hiatal Hernia Recurrence rate

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 5 years postoperatively

  17. Number of subjects requiring 30 day readmission

    Measured: 30 days following surgery

  18. Number of subjects requiring reoperation

    Measured: 30 days following surgery

  19. Number of subjects developing postoperative Infection

    Measured: 30 days following surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2024
  2. Study start10 Jun 2024
  3. Primary completionJul 2027 (estimated)
  4. Study completionJul 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06444347
Sponsor's protocol ID
23-11026766
Status last verified
Aug 2026
First submitted
30 May 2024
Last updated
19 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Biosynthetic Mesh and Hiatal Hernia Repair in people with Hiatal Hernia, run by Weill Medical College of Cornell University at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Annabel Endean, NP (646-962-5250, ant2028@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anatomic hiatal hernia recurrence rate (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06444347, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.

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