SurgiMend Mesh at the Hiatus

Study Overview
=================
Brief Summary
-----------------
Prospective, single-arm, open-label study to evaluate re-occurrence and quality of life in subjects undergoing primary Hiatal hernia repair using SurgiMend biological mesh. Up to 15, with a target of 10, subjects are planned to be enrolled at one site. All subjects will receive the SurgiMend mesh during surgery. Data collected will be compared to historical data. Subjects will complete a pre-operative visit. After surgery, in addition to any standard of care visits, subjects will complete 3- and 6-month follow-ups involving a phone QOL survey and will have an upper GI series at 6 months.

Official Title
-----------------
Hiatal Hernia Repair Using Surgimend Mesh: A Pilot Study

Conditions
-----------------
Hiatal Hernia

Intervention / Treatment
-----------------
* Device: SurgiMend Mesh


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of type 3 or 4 hiatal hernia (8) Subject is able to give informed consent Adults at least 18 years of age Exclusion Criteria: Currently pregnant Prior hiatal hernia repair Prior gastric surgery Prior foregut surgery Known esophageal dysfunction or dysmotility Cirrhosis or ascites Known malignancy Known allergy to biologic mesh Known allergy to barium or other contrast material used in UGI Religious objection to animal implant Cognitive impairment Prisoners

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: SurgiMend Mesh<br>SurgiMend Mesh - FDA approved noncross-linked bovine dermis biologic mesh. SurgiMend Mesh will be used according to FDA approved recommendations for the use of abdominal wall hernia reinforcement. SurgiMend is intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue membranes. SurgiMend is specifically indicated for: Hernia repair including abdominal, inguinal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias. | Device: SurgiMend Mesh<br>* Following placement of SurgiMend mesh during laparoscopic hiatal hernia repair, patient will be scheduled for follow up using an upper GI series to check for recurrence of the hiatal hernia. Follow up upper GIs will be performed at 6 months post-surgery. Subjects will also complete a QOL survey to assess other GI associated symptoms before and after surgical repair. The QOL survey can be administered by phone by study team members<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence Rate | Recurrence rate will be analyzed by a Upper gastrointestinal tract radiography (UGI) and clinical evaluation in conjunction with patient's reported physiological assessment per the GERD-HRQL. | 6 months post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life Using GERD-HRQL Scale | The GERD-HRQL was initially developed to measure the typical symptoms of GERD and their effect on a patient's quality of life. It was initially determined to have face validity and subsequent studies assessed its content validity and criterion validity. Reliability was determined by the test-retest method. This instrument is practical, with little administrative burden and has been validated for use via the telephone call. Scale is 0-5 with 0 being no symptoms and 5 being symptoms are incapacitating. | pre-operative and 3 month and 6 month post surgery |