Complications, Outcomes and Revisions Following Hiatal Hernia Repair With MIROMESH

Study Overview
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Brief Summary
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Investigator will identify a consecutive cohort of patients who have undergone a hiatal hernia repair and are at least 6 months post index procedure.

Detailed Description
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Planned Sample Size: At minimum of 70 consecutive subjects at least 6-months post-index procedure Study Population: A consecutive cohort of patients who have undergone a hiatal hernia repair with MIROMESH. Primary Objective: Characterize the procedural and early post-operative safety profile of MIROMESH when used as reinforcement in hiatal hernia repair. Secondary Objectives A retrospective chart review will identify the appropriate cohort with a prospective follow-up survey to acquire safety and outcome information. A retrospective chart review of appropriate subjects. Data to be acquired will be: Preoperative - Chart Review Gender Date of birth Weight Body Mass Index Specific diagnosis DeMeester Score 24 hour pH test (% acid exposure in 24 hours) Gastroesophageal Reflux Disease Health Related Quality of Life (GERD-HRQL) Score Peri-operative Preoperative - Chart Review Date of surgery Number of stitches used to close wound Paraesophageal hernia type Mesh shape Mesh size used Attachment technique Length of stay Complications Post-Operative (With-in 1 month of surgery) Preoperative - Chart Review Complications (Mesh related) Complications (procedure related) Prolonged dysphagia (Y/N) Stenosis (Y/N) Dilations (Y/N) Esophagogastroduodenoscopy or Upper gastrointestinal series documented hernia recurrence GERD-HRQL Score Prospective institutional review board approved Follow-Up Telephone Interview Have you had a revision surgery? GERD-HRQL Score How satisfied are you with the procedure? Have you used proton pump inhibitors in the last 3 months How likely are you to recommend this procedure to a loved one?

Official Title
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Complications and 1-Year Outcomes Following Hiatal Hernia Repair With MIROMESH a Novel, Highly Vascular, Porcine Derived, Biologic Matrix

Conditions
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Hiatal Hernia With Gastroesophageal Reflux Disease, Gastroesophageal Reflux, GERD

Intervention / Treatment
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* Biological: Hepatic derived surgical matrix


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Had a hiatal hernia repair with MIROMESH greater than 6 months prior to study Exclusion Criteria: N/A
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observations Group<br>Patients who have undergone a hiatal hernia repair with MIROMESH. | Biological: Hepatic derived surgical matrix<br>* Hiatal hernia repair with MIROMESH<br>* Other names: MIROMESH Biologic Matrix;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects Who Required a Revision of the Index Surgery. | Patient self-report if they had a revision or other laparoscopic surgery following index procedure. | 6-18 months post index procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastroesophageal Reflux Disease Health Related Quality of Life Score (GERD-HRQL) | The GERD-HRQL score assess the severity of GERD symptomatic and impact on the subjects quality of life. The score is comprised of 10 questions whose answers are summed for the final score. THe score can range from 0 to 50, with 50 being the worst and 0 meaning no impact. | 6-18 months post index procedure | 
| Medication Use | Use of PPIs in 3-months prior to follow-up interview | 6-18 months post index procedure |