Hiatal Hernia Repair Using Surgimend Mesh: A Pilot Study
Phase: NA
Conditions: Hiatal Hernia
Sponsor: Kettering Health Network

PROTOCOL TITLE: Hiatal Hernia Repair Using Surgimend Mesh: A Pilot Study 
 
 
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Revised: April 16, 2019 
PROTOCOL TITLE: 
Hiatal Hernia Repair Using Surgimend Mesh: A Pilot Study 
PRINCIPAL INVESTIGATOR: 
Paul Levy, DO 
General Surgery 
937-531-0195 
Paul.levy@ketteringhealth.org 
VERSION NUMBER/DATE: 
Version 4.0, Revision 3 11SEP2020 
REVISION HISTORY 
 
Revision 
# 
Version Date 
Summary of Changes 
Consent 
Change? 
1 
03/31/2020 
Added time windows to visits  
No  
2 
08/07/2020 
Added language for remote consenting and 
remote visits 
No 
3 
09/11/2020 
Adjusted time windows for visits 
No 
 
 
 
 
 
 
 
 
 
Table of Contents 
1.0 
Study Summary ........................................................................................................ 3 
2.0 
Objectives* .............................................................................................................. 4 
3.0 
Background* ............................................................................................................ 4 
4.0 
Study Endpoints* ..................................................................................................... 4 
5.0 
Study Intervention/Investigational Agent ................................................................ 4 
6.0 
Procedures Involved*............................................................................................... 5 
7.0 
Data and Specimen Banking* .................................................................................. 7 
8.0 
Sharing of Results with Subjects* ........................................................................... 7 
9.0 
Study Timelines* ..................................................................................................... 7 
10.0 Inclusion and Exclusion Criteria* ............................................................................ 7 
11.0 Vulnerable Populations* .......................................................................................... 8 
12.0 Local Number of Subjects ....................................................................................... 8 
13.0 Recruitment Methods ............................................................................................... 8 
14.0 Withdrawal of Subjects* .......................................................................................... 8 
15.0 Risks to Subjects* .................................................................................................... 9 
16.0 Potential Benefits to Subjects* ................................................................................ 9 
17.0 Data Management* and Confidentiality .................................................................. 9 
18.0 Provisions to Monitor the Data to Ensure the Safety of Subjects* ........................ 10 
19.0 Provisions to Protect the Privacy Interests of Subjects .......................................... 10 
20.0 Compensation for Research-Related Injury ........................................................... 10 
21.0 Economic Burden to Subjects ................................................................................ 10 

PROTOCOL TITLE: Hiatal Hernia Repair Using Surgimend Mesh: A Pilot Study 
 
 
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22.0 Consent Process ..................................................................................................... 10 
23.0 Process to Document Consent in Writing  ............ 9Error! Bookmark not defined. 
24.0 Setting .................................................................................................................... 10 
25.0 Resources Available............................................................................................... 10 
26.0 Multi-Site Research* ............................................................................................. 11 
 
 
 

PROTOCOL TITLE: Hiatal Hernia Repair Using Surgimend Mesh: A Pilot Study 
 
 
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1.0 
Study Summary 
 
Study Title 
Hiatal Hernia Repair Using SurgiMend Mesh at the hiatus: A Pilot 
Study 
Study Design 
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. 
Primary Objective 
Recurrence rates of hiatal hernia as compared to historical rates 
Secondary 
Objective(s) 
To evaluate quality of life of patients in which SurgiMend mesh 
was used during Hiatal hernia surgery using the GERD-HRQL, 
compared to historical data.  
Research 
Intervention(s)/ 
Investigational 
Agent(s)  
Assessment of recurrence rates of hiatal hernias following use of 
SurgiMend mesh compared to historical rates 
IND/IDE #  
N/A 
Study Population 
Patients having a planned hiatal hernia repair 
Sample Size 
Up to 15, target of 10 
Study Duration for 
individual 
participants 
7 to 8 months (6 months post-surgery, plus up to 45 days prior to 
surgery) 
Schedule of 
Assessments 
Visit 
Pre-op/ 
baseline 
(w/in 45 
days 
pre-op) 
1-2 Week 
SOC 
follow-up 
(±2 weeks) 
3 Month 
Follow-
up (±2 
weeks) 
6 Month 
Follow-up 
(±2 
weeks) 
Informed 
Consent 
X  
 
 
 
Verify 
Eligibility 
Criteria 
X 
 
 
 
 
Quality of Life 
(QoL)* 
Questionnaire 
X  
 
X  
X  
Upper GI 
 
 
 
X  
AE 
Assessment* 
X 
X 
X 
X 
Vitals, Labs, 
EKG 
X 
X 
 
 

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*QoL and AE assessment can be done via phone call. Questionnaire 
used is the GERD Health-Related Quality of Life Questionnaire 
(GERD-HRQL)  
Study Specific 
Abbreviations/ 
Definitions  
Quality of Life: (QOL); Gastroesophageal reflux disease (GERD); 
Upper gastrointestinal tract radiography (UGI); Gastroesophageal 
Reflux Disease-Health Related Quality of Life (GERD-HRQL), 
Adverse Event (AE); Standard of Care (SOC) 
 
2. Objectives* 
2.1. Study recurrence rates of hiatal hernias after use of SurgiMend mesh 
compared to historical rates.  As available, recurrence rates will be 
compared to historical rates with and without using mesh for hernia 
repair.  
2.2. Assess the quality of life status post laparoscopic hiatal hernia repair with 
SurgiMend Mesh compared with historical rates as available 
3. Background 
3.1. Hiatal hernia repair is a surgical procedure with a well-recognized high 
recurrence rate of 25.5 % up to 50% and low post-op satisfaction and 
quality of life (1-3). Literature suggests that follow up imaging for 
evaluation of repair does not generally occur until 1 year post operatively 
with little data on when the recurrence actually occurred (1-3).  Biologic 
mesh has been studied as a possible adjunct in these surgeries to decrease 
recurrence and increase QOL. However, there are very few studies that 
have examined the actual recurrence rate following the use of mesh to 
reinforce the hiatal hernia repair.  We wish to study the efficacy of 
surgical mesh (Surgimend) for use in hiatal hernia repair to decrease 
recurrence and increase QOL 
3.2. Currently, there is conflict in the literature as to the best type of surgical 
procedure to be performed and there is little overall literature about the 
use of bovine dermis product used in hernia repair to reduce recurrence 
rate and QOL improve with the addition of mesh for a laparoscopic hiatal 
hernia repair.  There is some evidence that bovine dermis has the ability 
to adjust to the pressure points and is less likely to pull apart and tear 
under pressure.  This results in a decrease in mesh erosion ultimately 
resulting in less complications, including fewer recurrences. (4) 
4. Study Endpoints 
4.1. Primary Endpoint: Recurrence of hiatal hernia as assessed by upper GI 
and clinical evaluation. 
4.2. Secondary Endpoint: Quality of life as marked by GERD symptoms on 
GERD-HSQL (5) 
5. Study Intervention/Investigational Agent 

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5.1. Description: SurgiMend Mesh -FDA approved noncross-linked bovine 
dermis biologic mesh 
5.2. SurgiMend Mesh will be used according to FDA approved 
recommendations for the use of abdominal wall hernia reinforcement  
5.3. 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:  
5.3.1. Hernia repair including abdominal, inguinal, femoral, diaphragmatic, 
scrotal, umbilical, and incisional hernias. 
6. Procedures Involved 
6.1. Intervention: 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 and AE 
assessment can be administered by phone by study team members 
6.2. Study Calendar:  
Visit 
Pre-op/ 
baseline 
(within 45 
days of 
procedure) 
1-2 
Week 
SOC 
follow-
up (±2 
weeks) 
3 Month 
Follow-up 
(±2 
weeks) 
6 Month 
Follow-up 
(±2 weeks) 
Medical 
Records 
review 
throughout 
6 month 
follow up 
Informed Consent 
X  
 
 
 
 
Verify Eligibility 
Criteria 
X 
 
 
 
 
 
Quality of Life 
(QoL) Questionnaire 
X  
 
X  
X  
 
Upper GI 
 
 
 
X  
 
AE Assessment 
X 
X 
X 
X 
X 
Vitals, Labs, EKG 
X 
X 
 
 
X 
 
6.3. Patients having hiatal hernia repair performed by Dr. Levy, who is the PI 
for the study, will have Surgimend mesh placed as per the SurgiMend 
approved use.  
6.4. Dr. Levy and/or surgical residents who are named as study team members 
will introduce and explain the study to the patient. If the patient is 
interested, they will be provided with a copy of the complete informed 
consent form and one-page summary of the study.  A research 
coordinator will follow up with the patient by phone. If a patient decides 
to participate, informed consent will be obtained by a member of the 

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study team in the office prior to surgery or a coordinator will call the 
patient to ensure patient understanding and desire to proceed with 
enrollment in study prior to the day of surgery by completing telephone 
consent. For remote consent, telephone consent will be utilized, with two 
team members verifying consent and documenting on the ICF. A copy of 
the ICF will also be emailed or mailed to the subject to sign as well. The 
subject will then return the sign copy, via scan, fax, picture, or return hard 
copy via mail or next in-person visit and will be filed with the consent 
completed by 2-person verification. A research coordinator will confirm 
eligibility prior to the patient being enrolled in the study. 
6.5. After informed consent is obtained and eligibility is confirmed, the 
patient will answer the GERD-HRQL survey (please see 6.8.2 for details 
on the survey) prior to the day of surgery.  
6.6. The patient will then undergo the planned elective procedure for hiatal 
hernia repair. Following the procedure, they will be admitted and 
observed in the hospital per standard of care. After discharge, the patient 
will be seen in the office for a standard of care follow up visit 1 to 2 
weeks after discharge.  The patient will complete the same QOL survey at 
3 and 6 months as well as have a fluoroscopic Upper GI  with contrast at 
6 months to check for radiographic recurrence as outlined below. The 
research coordinator may administer the survey by telephone  
6.7. The research procedures for this study include UGI and QOL survey 
6.7.1. UGI is a procedure that uses a fluoroscopic x-ray examination with 
the use of an orally ingested barium-based or other contrast material 
(as determined by the radiologist performing the test) to visualize the 
esophagus, stomach, and duodenum.  This is a non-invasive test to 
identify abnormalities in the digestive tracts, including hiatal hernias 
(6).  
 
6.7.2. UGI Risks –  
6.7.2.1. 
Exposure to radiation (6mSv) is comparable to 2 years of 
background radiation 
(https://www.radiologyinfo.org/en/info.cfm?pg=safety-xray) 
6.7.2.2. 
Approximately ¼ the exposure of a CT 
6.7.2.3. 
allergic reaction to contrast material  
6.7.2.4. 
constipation/obstruction from incomplete passage of the 
contrast agen 
6.7.3. QOL survey: GERD-HRQL 
6.7.3.1. 
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 

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method. This instrument is practical, with little administrative 
burden and has been validated for use via the telephone call (5).  
6.7.3.2. 
Because this QOL survey is directly tied to how a patient’s 
gastrointestinal (GI) symptoms impact their quality of life, there 
is little risk for undue psychological harm or emotional distress  
experienced by the patient. 
6.8.  Recurrence rate will be analyzed by a UGI done 6 months 
postoperatively in conjunction with patient’s reported physiological 
assessment per the GERD-HRQL.  As indicated, the physician reviewing 
this information will follow up with patient to ensure proper care and 
future treatment. 
6.8.1. Patients will have an UGI x-ray at 6 months postoperatively 
6.8.1.1. 
The UGI will be scheduled by a study team member 
through central scheduling at KHN.   
6.8.1.2. 
The patient will be instructed to not eat, drink, smoke or 
chew gum for four hours prior to the exam. 
6.8.1.3. 
As determined by the radiologist, a pregnancy test may be 
required and will be paid for by the study. 
6.9. Data to be collected includes Standard-of-Care data, normally collected 
pre- and post-surgery.  Such data includes pre-operative and post-
operative lab tests, and EKG (if applicable), vitals, age, gender, BMI.  
While the patient is on the study, their medical will be reviewed to 
capture any unscheduled visits. 
6.9.1. The patient will be instructed to not eat, drink, smoke or chew gum 
for four hours prior to the exam. 
 
6.9.2. UGI x-ray uses a very small dose of ionizing radiation to produce 
pictures of the inside of the abdominal cavity.  
7. Data and Specimen Banking* 
7.1. N/A - no specimen Banking.  Data banking for future use is not planned. 
8. Sharing of Results with Subjects* 
8.1. Results of study will not be formally shared with the subjects, however 
individual subjects will be informed of their progress per usual care 
9. Study Timelines* 
9.1.1. Enrollment time period: up to 1.5 years or up to 15 patients 
9.1.2. Follow-up/completion of all study related activities – 2 years  
10. Inclusion and Exclusion Criteria* 
10.1.1. 
Inclusion 
10.1.1.1. Diagnosis of type 3 or 4 hiatal hernia (8) 

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10.1.1.2. Subject is able to give informed consent 
10.1.1.3. Adults at least 18 years of age 
10.1.2. 
Exclusion 
10.1.2.1. Currently pregnant 
10.1.2.2. Prior hiatal hernia repair 
10.1.2.3. Prior gastric surgery 
10.1.2.4. Prior foregut surgery 
10.1.2.5. Known esophageal dysfunction or dysmotility 
10.1.2.6. Cirrhosis or ascites  
10.1.2.7. Known malignancy 
10.1.2.8. Known allergy to biologic mesh 
10.1.2.9. Known allergy to barium or other contrast material used in 
 
UGI 
10.1.2.10. Religious objection to animal implant 
10.1.2.11. Cognitive impairment 
11. Vulnerable Populations* 
11.1. 
Prisoners will excluded from study due to the increased 
difficulty to follow patients and schedule non-medically necessary 
testing.  
 
12. Local Number of Subjects 
12.1. 
Enrollment up to 15 patients with a target of 10 patients. 
13. Recruitment Methods 
13.1. 
Patients screened at First Surgical Care (Dr. Levy’s main office) 
after referral. These patients will be approached by the surgeon regarding 
the study.  A member of the study team will explain the study to them in 
detail and give them an opportunity to ask questions.  
13.2. 
Patients will take consent and brief study overview home to review 
and given time to ask questions 
13.3. 
Consent will then be obtained at subsequent encounter or via 
telephone.  If consent is to be obtained on the day of surgery, a phone call 
conversation will be documented stating the consent document was 
reviewed in full and all questions were answered.  
13.4. 
Patients will be compensated for time and travel. 
13.4.1. At completion of the 3 month visit, patients will complete the 
quality of life questionnaire and will receive $25.  At the 6 month 
visit, patients will receive $50 at per visit.  Patients will need to 
complete both the UGI and the GERD-HRQL to receive stipend.  
Patient will receive a check from Kettering once all activities are 
completed for that timepoint.  
14. Withdrawal of Subjects* 

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14.1. 
Patients may withdraw consent at any time and cease to participate 
in additional research activities.  All previously collected data will be 
used in the analysis.  Further data will not be collected after subject 
withdraws 
15. Risks to Subjects* 
15.1. 
Breach of confidentiality is major risk for patients.  
15.1.1. See section 17.1 for mitigation of privacy risks 
15.2. 
Risk of UGI  includes the use of a small amount of ionizing 
radiation and the ingestion of barium or other contrast material.   
15.2.1.1. Exposure to radiation (6mSv) is comparable to 2 years of 
background radiation 
(https://www.radiologyinfo.org/en/info.cfm?pg=safety-xray) 
15.2.1.2. Approximately ¼ the exposure of a CT 
15.2.1.3. Reaction to the barium or other contrast material include 
allergic reaction, constipation/obstruction from incomplete 
passage of the contrast agent.  Patients will be instructed to 
drink plenty of fluids following the procedure to mitigate risk of 
constipation and obstruction 
15.3. 
Risk of allergic reaction to bovine mesh is approximately 3% in 
the general population (6,7). 
15.4. 
The overall risk of psychological impact of QOL survey is 
minimal.  This survey was designed to specifically assess the 
impact of GI symptoms on a patient’s quality of life.  Therefore, 
there is a minimal psychological impact as patients have already 
been enduring GI side effects from the hiatal hernia, including 
heartburn, pain, and reflux. 
16. Potential Benefits to Subjects* 
16.1.1. Subjects may or may not benefit.  Subjects may experience 
reduction in recurrence of hiatal hernia as well as improved QOL. 
17. Data Management* and Confidentiality 
17.1. 
Due to the low number of patients expected to be enrolled, 
statistical analysis will be descriptive in nature. Recurrence rates and 
QOL means may be compared to historical controls. 
17.1.1. Data to be collected: Demographics, vitals, surgical history, 
medications, recurrence of hernia, comorbidities, dysphagia and 
reflux symptoms, results of UGI for presence/absence of recurrence 
of hiatal hernia and labs including a complete blood count (CBC), 
complete metabolic panel (CMP), and an EKG, which are all 
standard of care for this procedure. 

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18. Provisions to Monitor the Data to Ensure the Safety of Subjects* 
18.1. 
Standard of care monitoring and follow-up; 24 hour patient 
accessibility to a physician; hospital follow-up phone call week of 
surgery per hospital protocol; phone interview by a member of the study 
team at 3 and 6 months.  Surgeon will be informed of and handle any 
potentially adverse events related to the study or surgical procedure. 
19. Provisions to Protect the Privacy Interests of Subjects 
19.1. 
Data will be encrypted and stored in a password protected shared 
drive accessible to study personal listed.  Only de-identified information 
will be shared with sponsor and statistician.   
20. Compensation for Research-Related Injury 
20.1. 
While the surgical procedure is considered greater than minimal 
risk, there is not an increase in risk using the SurgiMend mesh compared 
to other types of surgical mesh.  The patient will receive the usual 
perioperative care and SurgiMesh regardless of whether participating in 
the study.  There is no compensation set aside for injury while on study. 
21. Economic Burden to Subjects 
21.1. 
No anticipated additional economic burden will be placed on the 
participants as they will receive standard of care for surgery.  They will 
be compensated as described in section 13.4. 
22. Consent Process 
 
22.1. 
See above – section 13; patient will receive education about the 
study during their doctor visit and given a consent and study summary to 
take home and read.  When the patient returns, study questions will be 
answered and if willing to participate, patient will sign the consent.  
Alternatively, a member of the study team will call the patient to review 
the study and obtain informed consent over the phone. In such cases, the 
patient will sign consent documents on the day of surgery or the consent 
will be signed and documented by two study coordinators. 
23. Setting 
23.1. 
See section 13 for more detail.  Patients will be introduced to study 
at physicians office.  They will have surgery per standard of care at a 
KHN facility, followed by an SOC follow up office visit with the surgeon 
1 to 2 weeks post-surgery.  They will receive a phone call at 3 months 
and 6 months to fill out the GERD-HRQL and will travel to a KHN 
facility of their choice to have an abdominal X-Ray performed at the 6 
month time points.  
24. Resources Available 

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24.1. 
Physician has allocated time for research; residents are required to have 
research done prior to graduation. 
25. Multi-Site Research* 
25.1.1. N/A 
26. References 
 
26.1. 
Furnée, E., Hazebroek, E. Mesh in laparoscopic large hiatal hernia repair: 
a systematic review of the literature. Surg Endosc 27, 3998–4008 (2013) 
doi:10.1007/s00464-013-3036-y 
26.2. 
Lidor AO, Steele KE, Stem M, Fleming RM, Schweitzer MA, Marohn 
MR. Long-term Quality of Life and Risk Factors for Recurrence After 
Laparoscopic Repair of Paraesophageal Hernia. JAMA Surg. 2015;150(5):424–
431. doi:https://doi.org/10.1001/jamasurg.2015.25 
26.3. 
Nason, K.S., Luketich, J.D., Qureshi, I. et al. Laparoscopic Repair of 
Giant Paraesophageal Hernia Results in Long-Term Patient Satisfaction and a 
Durable Repair. J Gastrointest Surg 12, 2066–2077 (2008) doi:10.1007/s11605-
008-0712-7 
26.4. 
Adelman DM, Selber JC, Butler CE. Bovine versus Porcine Acellular 
Dermal Matrix: A Comparison of Mechanical Properties. Plast Reconstr Surg 
Glob Open. 2014;2(5):e155. Published 2014 Jun 6. 
doi:10.1097/GOX.0000000000000072 
26.5. 
Velanovich V The development of the GERD-HRQL symptom severity 
instrument.  Dis Esophagus. 2007;20(2):130-4. 
26.6. 
Radiologic Society of North America (2019).  Radiation dose in X-Ray 
and CT Exam.  Available at 
https://www.radiologyinfo.org/en/info.cfm?pg=safety-xray 
26.7. 
K. S. Silvipriya, K. Krishna Kumar*, A. R. Bhat, B. Dinesh Kumar, Anish 
John, Panayappan Lakshmanan.  Collagen: Animal Sources and Biomedical 
Application.  Journal of Applied Pharmaceutical Science Vol. 5 (03), pp. 123-
127, March, 2015.  DOI: 10.7324/JAPS.2015.50322 
26.8. 
Kahrilas, Peter J.; Kim, Hyon C.; Pandolfino, John E. (2008). 
"Approaches to the diagnosis and grading of hiatal hernia". Best Practice & 
Research Clinical Gastroenterology. 22 (4): 601–616. 
doi:10.1016/j.bpg.2007.12.007. PMC 2548324. PMID 18656819