Health TrialsbyHealthPanel

Impact of Biosynthetic Mesh on Paraesophageal Hernia Repair

ConditionHiatal Hernia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWeill Medical College of Cornell University

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Documented diagnosis of gastroesophageal reflux disease

Adults aged 18 years or older

English speaking

Subject is planned to undergo surgery for reflux disease

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • 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/Surgery

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

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Biosynthetic MeshExperimental treatment 2 interventions
Group B: No MeshActive comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Weill Medical College of Cornell University

Lead sponsor

Intuitive Surgical

Collaborator

Source ClinicalTrials.gov
Apply now