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NCT Number: NCT06444347

Impact of Biosynthetic Mesh on Paraesophageal Hernia Repair

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.

Recruiting

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Southern California Keck School of Medicine, Los Angeles, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Hiatal Hernia Repair

Procedure

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

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

    Time frame: 2 weeks postoperatively

    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.

  4. Reflux Symptoms

    Time frame: 6 months postoperatively

    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.

  5. Reflux Symptoms

    Time frame: 1 year postoperatively

    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.

  6. Reflux Symptoms

    Time frame: 2 years postoperatively

    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.

  7. Reflux Symptoms

    Time frame: 3 years postoperatively

    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.

  8. Reflux Symptoms

    Time frame: 4 years postoperatively

    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.

  9. Reflux Symptoms

    Time frame: 5 years postoperatively

    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.

  10. Dysphagia Symptoms

    Time frame: 2 weeks postoperatively

    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.

  11. Dysphagia Symptoms

    Time frame: 6 months postoperatively

    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.

  12. Dysphagia Symptoms

    Time frame: 1 year postoperatively

    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.

  13. Dysphagia Symptoms

    Time frame: 2 years postoperatively

    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.

  14. Dysphagia Symptoms

    Time frame: 3 years postoperatively

    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.

  15. Dysphagia Symptoms

    Time frame: 4 years postoperatively

    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.

  16. Dysphagia Symptoms

    Time frame: 5 years postoperatively

    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.

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Annabel Endean, NP

CONTACT

[email protected]

646-962-5250

Niloufar Salehi, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • Intuitive Surgical

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2030
First posted
Jun 5, 2024
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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