Hiatal Hernia
Conditions
Brief 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.
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.
Sponsors
Weill Medical College of Cornell University
Intuitive Surgical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anatomic hiatal hernia recurrence rate | 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anatomic Hiatal Hernia Recurrence rate | 3 years | — |
| Reflux Symptoms | 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. |
| Dysphagia Symptoms | 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. |
| Number of subjects requiring 30 day readmission | 30 days following surgery | — |
| Number of subjects requiring reoperation | 30 days following surgery | — |
| Number of subjects developing postoperative Infection | 30 days following surgery | — |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRasa Zarnegar, MD
Weill Medical College of Cornell University
CONTACTNiloufar Salehi, MD
CONTACTAnnabel Endean, NP
Outcome results
None listed