Ultrasound Assessment of Ventral Hernia Defects
Phase: NA
Conditions: Ventral Incisional Hernia
Sponsor: University of Pennsylvania

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NCT # 03043079 
 
Protocol Number: 823896 
 
Protocol Title: Ultra Sound Assessment of Ventral Hernia Defects 
 
Document Date:  December 09, 2015 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Page 2 of 16 
 
 
 
 
Protocol Details 
 
Basic Info 
Confirmation Number: 
bjhhbige 
Protocol Number: 
823896 
Created By: 
LANNI, MICHAEL 
Principal Investigator: 
FISCHER, JOHN P 
Protocol Title: 
Ultrasound Assessment of Ventral Hernia Defects 
Short Title: 
ARFI Hernia 
Protocol Description:     Through the use of ultrasound including sheer wave velocity measurements, the abdominal wall     of 
25 subjects scheduled to have ventral hernia repair will be compared to those of 25 healthy 
volunteers. The ultrasound measurements will elucidate if ventral hernia affects abdominal wall 
elasticity and reveal and effect on surgical outcomes. 
Submission Type: 
Biomedical Research 
Application Type: 
FULL 
Resubmission* 
Yes 
 
 
 
Study Personnel 
Principal Investigator 
Name: 
FISCHER, JOHN P 
Dept / School / Div: 
4502 - SU-Surgery Administration 
Campus Address 
6070 
Mail Code 
Address: 
HARRISON - 313 STMLR 
3450 HAMILTON WALK 
City State Zip: 
PHILADELPHIA PA 19104-6070 
Phone: 
215-459-2018 
Fax: 
215-615-0474 
Pager: 
Email: 
John.Fischer2@uphs.upenn.edu 
HS Training Completed: 
Yes 
Training Expiration Date: 
01/29/2016 
Name of course completed : 
CITI Protection of Human Subjects Research Training - ORA 

Page 3 of 16 
 
Study Contacts 
Name: 
LANNI, MICHAEL 
Dept / School / Div: 
2100 - Health System 
Campus Address 
Mail Code 
Address: 
Hospital of the Univ of Penn 
Surgery Residents 
City State Zip: 
Phone: 
- 
Fax: 
- 
Pager: 
Email: 
Michael.Lanni@uphs.upenn.edu 
HS Training Completed: 
Yes 
Training Expiration Date: 
06/28/2018 
Name of course completed : 
CITI Protection of Human Subjects Research Training - ORA 
Name: 
FOLSOM, NANCY 
Dept / School / Div: 
2100 - Health System 
Campus Address 
Mail Code 
Address: 
3400 Civic Center Blvd. 
South Pavilion Expansion 
City State Zip: 
Philadelphia PA 19104-0000 
Phone: 
- 
Fax: 
- 
Pager: 
Email: 
Nancy.Folsom@uphs.upenn.edu 
HS Training Completed: 
Yes 
Training Expiration Date: 
02/10/2017 
Name of course completed : 
CITI Protection of Human Subjects Research Training - ORA 
Name: 
GABRIELSEN, DAVID 
Dept / School / Div: 
2100 - Health System 
Campus Address 
Mail Code 
Address: 
Contracted Emp Non-UPHS Paid 
Medicine Students 
City State Zip: 
ID 
Phone: 
- 
Fax: 
- 
Pager: 
Email: 
David.Gabrielsen@pennmedicine.upenn.edu 
HS Training Completed: 
Yes 
Training Expiration Date: 
04/25/2018 
Name of course completed : 
CITI Protection of Human Subjects Research Training - ORA 

Page 4 of 16 
 
Other Investigator 
Name: 
SEHGAL, CHANDRA M 
Dept / School / Div: 
4452 - RA-Radiology 
Campus Address 
4283 
Mail Code 
Address: 
1 SILVERSTEIN 
RADIOLOGY 
3400 SPRUCE ST. 
City State Zip: 
PHILA PA 19104-4283 
Phone: 
215-349-5461 
Fax: 
215-615-4666 
Pager: 
Email: 
sehgalc@uphs.upenn.edu 
HS Training Completed: 
Yes 
Training Expiration Date: 
02/03/2018 
Name of course completed : 
CITI Protection of Human Subjects Research Training - ORA 
 
Responsible Org (Department/School/Division): 
 
4502 - SU-Surgery Administration 
 
Key Study Personnel 
Name: 
WERNER, NATALIE 
Department/School/Division: 
Health System 
HS Training Completed: 
Yes 
Training Expiration Date: 
11/17/2016 
Name of course completed: 
CITI Protection of Human Subjects Research Training - ORA 
Name: 
SCHULTZ, SUSAN 
Department/School/Division: 
RA-Radiology 
HS Training Completed: 
Yes 
Training Expiration Date: 
01/09/2017 
Name of course completed: 
CITI Protection of Human Subjects Research Training - ORA 
Name: 
KOVACH, STEPHEN J 
Department/School/Division: 
SU-Surgery Administration 
HS Training Completed: 
Yes 
Training Expiration Date: 
09/15/2017 
Name of course completed: 
CITI Protection of Human Subjects Research Training - ORA 
Name: 
GABRIELSEN, DAVID 
Department/School/Division: 
Health System 
HS Training Completed: 
Yes 
Training Expiration Date: 
04/25/2018 
Name of course completed: 
CITI Protection of Human Subjects Research Training - ORA 

Page 5 of 16 
 
Name: 
CHAUHAN, ANIL 
Department/School/Division: 
RA-Radiology 
HS Training Completed: 
Yes 
Training Expiration Date: 
11/03/2016 
Name of course completed: 
CITI Protection of Human Subjects Research Training - ORA 
Name: 
TECCE, MICHAEL 
Department/School/Division: 
Health System 
HS Training Completed: 
Yes 
Training Expiration Date: 
03/24/2018 
Name of course completed: 
CITI Protection of Human Subjects Research Training - ORA 
 
Disclosure of Significant Financial Interests* 
Does any person who is responsible for the design, conduct, or reporting of this research protocol have    
a FINANCIAL INTEREST? 
No 
 
Penn Intellectual Property* 
To the best of the Principal Investigator's knowledge, does this protocol involve  the  testing,  development 
or evaluation of a drug, device, product, or other type of intellectual property (IP) that is owned by or 
assigned to the University of Pennsylvania? 
 
Certification 
I have reviewed the Financial Disclosure and Presumptively Prohibited Conflicts for Faculty Participating 
in Clinical Trials and the Financial Disclosure Policy for Research and Sponsored  Projects with all 
persons who are responsible for the design, conduct, or reporting of this research; and all required 
Disclosures have been attached to this application. 
Yes 
 
 
 
Biomedical Research 
Clinical Trial* 
Is this a clinical trial? 
 
Investigator Initiated Trial* 
Is this an investigator initiated trial? 
No 
 
Drugs or Devices* 
Does this research study involve Drugs or Devices? 
Yes: Investigational devices that may qualify as Non-Significant Risk. 
 
IND Exemption 
 
 
For studies that fall under an IND exemption, please provide the number below 
For studies including IND or IDE's, please provide the number(s) below 
IDE Review* 
NOTE: For research involving investigational devices, you are required to review the guidance on 
Managing Research Device Inventory. Consult the Penn Manual for Clinical Research: https:// 
somapps.med.upenn.edu/pennmanual/secure/pm/investigational-product-management Please check the 
box Yes if you have reviewed the guidance. 

Page 6 of 16 
 
Yes 
 
Research Device Management* 
Please indicate how research device(s) will be managed. 
Not Applicable (no investigational devices) 
 
Drug, Herbal Product or Other Chemical Element Management  * 
Please indicate how drugs, herbal products or other chemical entities will be managed. 
Not Applicable (no drugs, herbal products or other chemical entities) 
 
Radiation Exposure* 
Are research subjects receiving any radiation exposure (e.g. X-rays, CT, Fluoroscopy, DEXA, pQCT, 
FDG, Tc-99m, etc.) that they would not receive if they were not enrolled in this protocol? 
No 
 
Gene Transfer* 
Does this research involve gene transfer (including all vectors) to human subjects? 
No 
 
Human Source Material* 
Does this research include collection or use of human source material (i.e., human blood, blood  
products, tissues or body fluids)? 
No 
 
CACTIS and CT Studies* 
Does the research involve Center for Advanced Computed Tomography Imaging Services (CACTIS)  
and CT studies that research subjects would not receive if they were not part of this  protocol? 
No 
 
CAMRIS and MRI Studies* 
Does the research involve Center for Advanced Magnetic Resonance Imaging and Spectroscopy 
(CAMRIS) and MRI studies that research subjects would not receive if they were not part of this protocol? 
No 
 
Investigational Agent or Device within the Operating Room* 
Does the research project involve the use of an investigational agent or device within the Operating 
Room? 
No 
 
Cancer Related research not being conducted by an NCI cooperative group* 
Does this protocol involve cancer-related studies in any of the following categories? 
No 
 
Processing of Materials* 
Will the research involve processing (such as over encapsulating, or compounding)? 
No 
 
In-House Manufacturing of Materials* 
Will the research involve processing (such as over encapsulating, or compounding)? 
No 
 
Medical Information Disclosure* 
Does the research proposal involve the use and disclosure of research subject's medical information for 
research purposes? 
Yes 
 
If the answer is YES, indicate which items is is provided with this submission: 
 
Modified research informed consent document that incorporates HIPAA  requirements 

Page 7 of 16 
 
CTRC Resources* 
Does the research involve CTRC resources? 
No 
 
Pathology and Laboratory Medicine Resources* 
Will samples be collected by hospital phlebotomy and/or processed or analyzed by any of the clinical 
laboratories of the University of Pennsylvania Health System? 
No 
 
Research Involves Apheresis, Cell Collection, and/or Blood Product Collection* 
Does this research involve collection of blood products in the Penn Donor Center and/or the use of 
apheresis for treatment or collection of cells or other blood  components? 
No 
 
Research involving blood transfusion or drug infusions* 
Will your research involve blood transfusion or infusion of study drug in 3 Ravdin Apheresis Unit for 
research purposes? 
No 
 
Trial in Radiation Oncology 
Is this research a prospective trial being done in Radiation Oncology, and if so, has this protocol been 
approved by the Radiation Oncology Protocol committee? 
N/A 
 
Study in Radiation Oncology 
Is this research a retrospective study being done in Radiation Oncology, and if so, has this project been 
reviewed by the Radiation Oncology Clinical Research Group? 
N/A 
 
Use of UPHS services* 
Does your study require the use of University of Pennsylvania Health System (UPHS) services, tests or 
procedures*, whether considered routine care or strictly for research  purposes? 
Yes 
 
Primary Focus* 
Clinical Trial (prospectively assigning subjects to health-related interventions to evaluate outcomes) 
 
Protocol  Interventions 
Sociobehavioral (i.e. cognitive or behavioral therapy) 
Drug 
Device - therapeutic 
Device - diagnostic (assessing a device for sensitivity or specificity in disease  diagnosis) 
Surgical 
x Diagnostic test/procedure (research-related diagnostic test or procedure) 
Obtaining human tissue for basic research or biospecimen bank 
Survey instrument 
None of the above 
 
The following documents are currently attached to this item: 
 
There are no documents attached for this item. 
 
Department budget code 
 
None 

Page 8 of 16 
 
Multi-Site Research 
Other Sites 
No other sites 
 
Management of Information for Multi-Center Research 
na 
 
The following documents are currently attached to this item: 
 
There are no documents attached for this item. 
 
 
Protocol 
Abstract 
Quantitative radiographic imaging holds promise as a novel and innovative strategy to assess ventral hernia 
patients. We will identify features of the abdominal wall that differ between healthy volunteers and subjects 
scheduled to have ventral hernia repair. We will assess abdominal wall  changes  surrounding ventral hernia 
using shear wave velocity values measured with ultrasound. Up to  25  subjects previously diagnosed with 
ventral hernia seeking surgical repair will receive ultrasound prior to repair and following repair and will 
be compared to up to 25 healthy  volunteers. 
 
Objectives 
Overall objectives 
Identify characteristic changes in the abdominal wall associated with ventral hernia. Determine elasticy of 
the abdominal wall in subjects known to have a hernia defect to those who are determined to have normal 
abdominal wall anatomy. 
 
Primary outcome variable(s) 
Sheer wave velocity measurements in the abdominal wall. 
 
Secondary outcome variable(s) 
Identification of any association between muscular elasticity/stiffness of the abdominal and surgical 
data/outcomes of the hernia repair. 
 
Background 
Significance of hernia and magnitude of the problem: Two million abdominal surgeries are performed 
annually in the United States, and ventral hernia (VH) is among the most common and serious 
complications(1, 2). The incidence of VH is approximately 13%(3), but as high as 70% in high-risk 
populations(1, 4-8). Despite improving surgical treatment strategies and mesh technology, long-term 
success rates of VH repair remain unacceptably low. The 348,000 VH repairs performed in 2006 cost over 
$3 billion (2). As a result of recurrence and morbidity, a disproportionately small subset (15%) of patients 
consumes more than 50% of expenditures(9), and become caught in the vicious cycle of hernia recurrence 
and morbidity. Failed repairs generate un-closable midline defects that require  mesh  bridging, meaning 
that native fascia cannot be closed and that mesh is bridged across  the  fascia. Bridging is a relevant and 
clinically meaningful outcome that occurs during the repair and has  significant implications since these 
repairs fail in 44 to 100% of cases and are associated  with  significant cost (8, 10-13). Patients suffering 
from recurring hernia experience deterioration in quality- of-life, significant disability, and dysfunction; if 
un-closable defects can be identified using a point-of- care technology peri-operative decision-making 
could be substantially improved. Role of imaging in hernia care: There are currently no reliable data, 
standard imaging modalities, or guidelines available to predict successful fascial closure in hernia repair, 
which represents a substantial gap in knowledge and barrier to progress (4, 14-16). Surgeons are unable to 
adequately counsel patients and preoperatively  plan complex VH repairs, which presents a clinical 
dilemma. The current state of hernia repair relies heavily on clinical evaluation of patients, which, as stated, 
is ultimately a poor predictor of patient outcome going into surgery for hernia repair. Additionally, there 
is a dearth of data regarding the use of various imaging modalities to diagnose and predict hernia outcomes 
of any kind. As of today, the only 

Page 9 of 16 
 
recommended radiologic technique for the evaluation of hernia is CT, a costly and ultimately ineffective 
measure (17). If a technique leveraging the strengths of ultrasound (US) could be developed, it would   be 
far superior to other modalities in terms of cost, time, and patient safety (Table 1) (18). There is little 
evidence regarding the role of ultrasound performed by surgeons in the diagnosis of hernias of any type 
Clearly, hernia ultrasound has the potential to be highly useful for surgical practice, however a well- 
designed trial needs to be carried out(14). Hernia leads to abdominal wall muscle fibrosis and decreased 
compliance, which presents an opportunity to quantify this change using specialized  imaging  techniques. 
Muscle fibrosis impedes closure (leading to bridging), and unloaded skeletal muscle undergoes 
architectural atrophic changes such as altered fiber composition, diminished cross-sectional area, and 
fibrosis that has been shown to be detectable and quantifiable (19, 20). Quantitative imaging using 
Acoustic Radiation Forced Impulse Shear Wave Velocity (ARFI-SWV) holds promise as a novel and 
innovative strategy to assess skeletal muscle pathology(21), and has already proven useful in evaluating 
fibromuscular disorders by quantitating stiffness and fibrosis (21, 22). Hernia  repair  outcomes are likely 
impacted by morphological changes that occur in the abdominal wall when significant fibrosis occurs. 
Clinically relevant target features include abdominal wall muscle thickness, pre-existing defects in the 
abdominal wall, or assessment of mechanical characteristics of muscular  layers such as fibrosis or fatty 
infiltration (19, 20, 23). Clinical Implications and Future Directions: Completing this study will provide 
an opportunity to advance the applications of ARFI-SWV  US imaging modalities for risk prediction of 
complex VH defects, translating this tool into the clinic as a point-of-care prognostic aid. The ability to 
preoperatively identify un-closable hernia defects represents an innovative strategy to an unmet clinical 
need with the potential to greatly impact thousands of  patients. Following this critical, inter-disciplinary 
pilot, our team will have a reproducible and reliable quantitative tool. This translational research of proven 
concepts across multiple  medical  fields  represents a significant collaborative effort and is just the first 
step that will be the foundation for future studies. The results of this proposal will be used to refine a 
protocol for  preoperative  shear  wave velocity assessment in complex VH patients. The proposed 
translational research study represents a strong and promising collaborative effort between radiology, 
biomedical imaging, and surgery that will build upon recent work and cutting edge technology, setting in 
motion future research opportunities.   The NIH states, The success of a potential shift from curative 
medicine, to predictive, personalized, and preemptive medicine could rely on the development of portable 
diagnostic and monitoring devices for point-of-care testing(25). It is with this notion in mind that we 
propose this work. We hope to develop a point-of-care technique that will allow the surgeon to pre-
operatively assess the outcome of surgery at the bedside. Establishing a point-of-care test will allow 
surgeons to personalize their approach to each patient and avoid submitting patients to the spiral of hernia 
recurrence and morbidity. References 1. Candage R, Jones K, Luchette FA, Sinacore JM, Vandevender D, 
Reed RL, 2nd. Use of human acellular dermal matrix for hernia repair: friend or foe? Surgery. 
2008;144(4):703-9; discussion 9-11. Epub 2008/10/14. doi: 10.1016/j.surg.2008.06.018. PubMed PMID: 
18847657. 2. Poulose BK, Shelton J, Phillips S, Moore D, Nealon W, Penson D, et al. Epidemiology and 
cost  of  ventral  hernia  repair: making the case for hernia research. Hernia. 2012;16(2):179-83. doi: 
10.1007/s10029-011-0879-9. PubMed PMID: 21904861. 3. Bosanquet DC, Ansell J, Abdelrahman T, 
Cornish J, Harries R, Stimpson A, et al. Systematic Review and Meta-Regression of Factors Affecting 
Midline Incisional Hernia Rates: Analysis of 14 618 Patients. PLoS One. 2015;10(9):e0138745. doi: 
10.1371/journal.pone.0138745. PubMed PMID: 26389785; PubMed Central PMCID: PMCPMC4577082. 
4. Franklin BR, Patel KM, Nahabedian MY, Baldassari LE, Cohen EI, Bhanot P. Predicting abdominal 
closure after component separation for complex ventral hernias: maximizing the use of preoperative 
computed tomography. Ann Plast      Surg.      2013;71(3):261-5.      Epub      2013/08/16.      doi:    
10.1097/SAP.0b013e3182773915 
00000637-201309000-00004 [pii]. PubMed PMID: 23945530. 5. Chavarriaga LF, Lin E, Losken A, Cook 
MW, Jeansonne LO, White BC, et al. Management of complex abdominal wall defects using acellular 
porcine dermal collagen. Am Surg. 2010;76(1):96-100. PubMed PMID: 20135948. 6. Le Huu Nho R, 
Mege D, Ouaissi M, Sielezneff I, Sastre B. Incidence and prevention of ventral incisional   hernia. J Visc 
Surg. 2012;149(5 Suppl):e3-14. Epub 2012/11/13. doi: 10.1016/j.jviscsurg.2012.05.004. PubMed PMID: 
23142402. 7. Veljkovic R, Protic M, Gluhovic A, Potic Z, Milosevic Z, Stojadinovic A. Prospective 
clinical trial of factors predicting the early development of incisional hernia after midline laparotomy. J 
Am Coll Surg. 2010;210(2):210-9. Epub 2010/02/02. doi: 10.1016/ j.jamcollsurg.2009.10.013. PubMed 
PMID: 20113942. 8. Basta MN, Fischer JP, Kovach SJ. Assessing complications and cost-utilization in 
ventral hernia repair utilizing biologic mesh in a bridged underlay technique. Am J Surg. 2015;209(4):695-
702. Epub 2014/10/13. doi: 10.1016/j.amjsurg.2014.04.017. PubMed PMID: 25305799. 9. Poulose BK, 
Beck WC, Phillips SE, Sharp KW, Nealon WH, Holzman MD. The chosen few: disproportionate resource 
use in ventral hernia repair. Am Surg. 2013;79  (8):815-8.  PubMed  PMID:  23896251.  10.  Itani  KM,  
Rosen  M, Vargo  D, Awad  SS,  Denoto  G, 3rd, 

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Butler CE. Prospective study of single-stage repair of contaminated hernias using a biologic porcine tissue 
matrix: the RICH Study. Surgery. 2012;152(3):498-505. Epub 2012/07/06. doi: 10.1016/ 
j.surg.2012.04.008. PubMed PMID: 22763262. 11. Jin J, Rosen MJ, Blatnik J, McGee MF,  Williams  CP, 
Marks J, et al. Use of acellular dermal matrix for complicated ventral hernia repair: does technique affect 
outcomes? 
J 
Am 
Coll 
Surg. 
2007;205(5):654-60. 
Epub 
2007/10/30. 
doi: 
10.1016/ 
j.jamcollsurg.2007.06.012. PubMed PMID: 17964441. 12. Purnell CA, Souza JM, Park E, Dumanian GA. 
Repair of recurrent hernia after biologic mesh failure in abdominal wall reconstruction. Am J Surg. 
2014;208(5):788-93.    Epub    2014/08/15.    doi:    10.1016/j.amjsurg.2014.05.008.    PubMed     PMID: 
25118163. 13. Patel KM, Nahabedian MY, Albino F, Bhanot P. The use of porcine acellular dermal  matrix 
in a bridge technique for complex abdominal wall reconstruction: an outcome analysis. Am J Surg.  
2013;205(2):209-12.  Epub  2012/12/01.  doi:  10.1016/j.amjsurg.2012.05.031.  PubMed    PMID: 
23195145. 14. Beggs AD, Thomas PR. Point of use ultrasound by general surgeons: review of the literature 
and suggestions for future practice. Int J Surg. 2013;11(1):12-7. Epub 2012/12/05. doi: 
10.1016/j.ijsu.2012.11.014. PubMed PMID: 23207511. 15. DiCocco JM, Magnotti LJ, Emmett KP, 
Zarzaur BL, Croce MA, Sharpe JP, et al. Long-term follow-up of abdominal wall reconstruction after 
planned ventral hernia: a 15-year experience. J Am Coll Surg. 2010;210(5):686-95, 95-8. Epub 
2010/04/28. doi: 10.1016/j.jamcollsurg.2009.12.034. PubMed PMID: 20421031. 16. Wormer BA, Walters 
AL, Bradley 3rd JF, Williams KB, Tsirline VB, Augenstein VA, et al. Does ventral hernia defect length, 
width, or area predict postoperative quality of life? Answers from a prospective, international study. 
Journal of Surgical Research. 2013;184(1):169-77. doi: http://dx.doi.org/10.1016/ j.jss.2013.04.034. 17. 
Bittner R, Bingener-Casey J, Dietz U, Fabian M, Ferzli GS, Fortelny RH, et al. Guidelines for laparoscopic 
treatment of ventral and incisional abdominal wall hernias (International Endohernia Society (IEHS)-part 
1. Surg Endosc. 2014;28(1):2-29. Epub 2013/10/12. doi: 10.1007/ s00464-013-3170-6. PubMed PMID: 
24114513; PubMed Central PMCID: PMC3872300. 18. Moore 
CL, Copel JA. Point-of-care ultrasonography. The New England journal of medicine. 2011;364 (8):749-
57.   Epub   2011/02/25.   doi:   10.1056/NEJMra0909487.   PubMed   PMID:   21345104.      19. 
Culbertson EJ, Xing L, Wen Y, Franz MG. Reversibility of abdominal wall atrophy and fibrosis after 
primary or mesh herniorrhaphy. Ann Surg. 2013;257(1):142-9. Epub 2012/07/18. doi: 10.1097/ 
SLA.0b013e31825ffd02.  PubMed  PMID:  22801088;  PubMed  Central  PMCID:  PMC4492691.    20. 
DuBay DA, Choi W, Urbanchek MG, Wang X, Adamson B, Dennis RG, et al. Incisional herniation 
induces decreased abdominal wall compliance via oblique muscle atrophy and fibrosis. Ann Surg. 
2007;245(1):140-6.   Epub   2007/01/02.   doi:   10.1097/01.sla.0000251267.11012.85.   PubMed  PMID: 
17197977; PubMed Central PMCID: PMC1867936. 21. Carpenter EL, Lau HA, Kolodny EH, Adler   RS. 
Skeletal Muscle in Healthy Subjects versus Those with GNE-Related Myopathy: Evaluation with Shear-
Wave US-A Pilot Study. Radiology. 2015;277(2):546-54. Epub 2015/06/03. doi: 10.1148/ 
radiol.2015142212. PubMed PMID: 26035587. 22. Drakonaki EE, Allen GM, Wilson DJ. Ultrasound 
elastography for musculoskeletal applications. Br J Radiol. 2012;85(1019):1435-45. Epub 2012/10/24. 
doi: 10.1259/bjr/93042867. PubMed PMID: 23091287; PubMed Central PMCID: PMC3500785. 23. 
Elsayes KM, Lammle M, Shariff A, Totty WG, Habib IF, Rubin DA. Value of magnetic resonance imaging 
in muscle trauma. Curr Probl Diagn Radiol. 2006;35(5):206-12. Epub 2006/09/05. doi: 
10.1067/j.cpradiol.2006.06.003. PubMed PMID: 16949477. 24. Knops AM, Legemate DA,  Goossens  A, 
Bossuyt PM, Ubbink DT. Decision aids for patients facing a surgical treatment  decision:  a  systematic 
review and meta-analysis. Ann Surg. 2013;257(5):860-6. doi: 10.1097/ SLA.0b013e3182864fd6. PubMed 
PMID: 23470574. 25. National Institutes of Health 2013 FS-P-o- CDT, viewed 16 Nov 2015, 
http://report.nih.gov/nihfactsheets/ViewFactSheet.aspx?csid=112. 
 
Study Design 
Phase* 
Not applicable 
 
Design 
Proposed Study Aims: Creating a protocol and using an existing technology to enhance informed risk 
counseling at the point-of-care will empower surgeons to personalize their approach to each patient, 
enhancing the informed decision process, fostering greater patient autonomy, and improving quality of 
care (24). ARFI-SWV US holds promise as an inexpensive, noninvasive, point-of-care diagnostic tool  for 
pre-operatively predicting successful repair at the bedside. We will measure abdominal wall features 
suitable for predicting successful closure of the midline fascia. To accomplish these goals, we propose  the 
following aims: Aim 1. To develop and refine a quantitative ultrasound protocol to  assess  mechanical 
changes in abdominal tissue. ARFI-SWV US represents a novel and intriguing modality   for 

Page 11 of 16 
 
real time visualization and characterization of changes in the biomechanical properties of diseased 
musculoskeletal tissues. We hypothesize that ARFI-SWV US can be used preoperatively to measure the 
stiffness in the lateral abdominal wall as an estimation for mobility during hernia repair. Demonstrating 
the utility of a cheap, point-of-care test for preoperatively evaluating hernia severity will prove to be a 
valuable, novel tool in surgical assessment of ventral hernia patients. Aim 2. To perform a prospective pilot 
ARFI-SWV US assessment of abdominal wall characteristics that predicts success  of  midline fascial re-
approximation in hernia patients. A prospective comparative analysis of preoperative ARFI- SWV US 
exams in patients undergoing hernia repair (N=25) will be performed. We hypothesize that fibrosis and 
other identifiable mechanical characteristics of the abdominal wall musculature can predict ability to close 
fascia in VH patients. Preoperative identification of ultrasound features characteristic of severe hernia 
defects can be used to predict which hernias will be un-closable, resulting in poorer outcomes. The study 
proposes to compare ultrasound images and associated shear wave velocity measurements between healthy 
subjects and subjects undergoing surgical repair for ventral hernia. We will compare up to 25 healthy 
volunteers with up to 25 ventral hernia subjects. Any female patients of child-bearing age will be asked to 
take a urine pregnancy test prior to being included in the study at the time of consent. Subjects with ventral 
hernia will undergo imaging no earlier than two weeks prior to elective hernia repair and within six months 
following repair at a standard followup visit. Medical information related to their hernia or hernia repair 
from these subjects will remain available for analysis for the duration of the study. Statistical analysis will 
determine if there is a significant difference in the abdominal wall stiffness, represented by the ultrasound 
shear wave velocity measurements, between the healthy subjects and the subjects with ventral hernia. 
Further analysis will determine if there is any statistically significant relationship between abdominal wall 
stiffness of subjects with ventral hernia and surgical outcomes, including bridged repairs, as well as any 
change in abdominal wall stiffness  following ventral hernia repair. 
 
Study duration 
All subjects will undergo about 40 minutes of ultrasound imaging. Subject who undergo hernia repair will 
have the same ultrasound imaging done at a standard follow up visit, within six months from the repair 
itself. following Subjects who undergo surgical repair for ventral hernia will have relevant information 
from their medical records included in the study for up to 1  year. 
 
Resources necessary for human research protection 
Describe research staff and justify that the staff are adequate in number and qualifications to conduct    the 
research. Describe how you will ensure that all staff assisting with the research are adequately informed 
about the protocol and their research related duties. Please allow adequate time for the researchers to 
conduct and complete the research. Please confirm that there are adequate facilities for   the research. 
All members of the study team completed mandatory CITI research training and agree to follow 
established guidelines to ensure the privacy and respect for study participants. The PI will provide 
oversight for the study. 
 
 
 
Characteristics of the Study Population 
Target population 
Up to 25 healthy, adult volunteer subjects and 25 adult subjects seeking surgical repair for ventral   hernia 
between the ages of 20 and 70. 
 
Subjects enrolled by Penn Researchers 
50 
 
Subjects enrolled by Collaborating Researchers 
0 
 
Accrual 
Patients of Dr. John Fischer, Dr. Sean Harbison, Dr. Noel Williams, Dr. Daniel Dempsey, or Dr. Stephen 
Kovach seeking surgical repair for ventral hernia will be invited to participate in the study by members  of 
the study team through word of mouth. Healthy volunteers will be invited through word of mouth   by 

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study team members and will be composed for the most part, friends, family, and colleagues. It will be 
clearly stated that participation is completely voluntary and that their participation is for the purpose of 
research. Because ultrasound is such a common diagnostic tool, it is anticipated that participants will know 
what is involved and that it is a painless procedure that takes less than an hour. 
 
Key inclusion criteria 
Adults between the ages of 20 and 70. Healthy volunteer (25) or subject seeking elective ventral hernia 
repair (25). 
 
Key exclusion criteria 
Pregnant women will not be included in the study. Although ultrasound is a common procedure during 
pregnancy, our results regarding abdominal wall stiffness as they relate to hernia repair would be 
compromised by not controlling for other factors that affect the abdominal wall, such as physiologic 
changes during pregnancy. 
 
Vulnerable Populations 
Children Form 
Pregnant women (if the study procedures may affect the condition of the pregnant woman or  
fetus) Form 
Fetuses and/or Neonates Form 
Prisoners Form 
Other 
x  None of the above populations are included in the research study 
 
The following documents are currently attached to this item: 
 
There are no documents attached for this item. 
 
Populations vulnerable to undue influence or coercion 
It will be clearly stated to any healthy volunteers who have an academic or professional relationship   with 
UPENN/UPHS, that participation is voluntary and has no impact on position or care at the health system 
or academic institution 
 
Subject recruitment 
Patients of Dr. John Fischer, Dr. Sean Harbison, Dr. Noel Williams, Dr. Daniel Dempsey, or Dr. Stephen 
Kovach seeking surgical treatment for ventral hernia will be recruited through word of mouth. Healthy 
volunteers will be invited through word of mouth by study team members and will be composed for the 
most part, friends, family, and colleagues. It will be clearly stated that participation is completely voluntary 
and that their participation is for the purpose of research. Because ultrasound is such a  common diagnostic 
tool, it is anticipated that participants will know what is involved and that it is a painless procedure that 
takes less than an hour. 
 
 
Will the recruitment plan propose to use any Penn media services (communications, marketing, etc.) for 
outreach via social media avenues (examples include: Facebook, Twitter, blogging, texting, etc.) or does 
the study team plan to directly use social media to recruit for the  research? 
No 
 
The following documents are currently attached to this item: 
 
There are no documents attached for this item. 
 
Subject compensation* 
Will subjects be financially compensated for their participation? 
No 
 
The following documents are currently attached to this item: 
 
There are no documents attached for this item. 

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If there is subject compensation, provide the schedule for compensation per study visit or session 
and total amount for entire participation, either as text or separate  document 
 
na 
 
 
 
Study Procedures 
Suicidal Ideation and Behavior 
Does this research qualify as a clinical investigation that will utilize a test article (ie- drug or biological) 
which may carry a potential for central nervous system (CNS) effect(s)? 
No 
 
Procedures 
First Encounter: After informed consent is obtained by a member of the study team, each healthy volunteer 
and patient seeking ventral hernia repair will undergo ultrasound imaging for about  40  minutes as per the 
procedure outlined below. Any women of childbearing age will be asked to take a urine pregnancy test 
prior to enrollment. The ultrasound machine is the Siemens Acuson S3000 and our protocol is within its 
FDA  approved label. The ultrasound imaging will focus on the abdominal wall   and avoid areas with the 
potential for incidental findings, such as the gall bladder.  Ultrasound   Protocol: 
1) Subject will be relaxed with shallow breathing and arm crossing over the chest. 2) Ultrasound transducer 
pressure will be minimal. 3) Ultrasound transducer will be perpendicular to the abdominal wall. 4) 
Transducer to be used: Linear or curved. 5) Grayscale Parameters: Abdominal wall musculature thickness 
in lateral mid abdomen (internal oblique, external oblique and transverse abdominis and   rectus abdominis 
muscles. 6) Measurements will be in orthogonal planes 7) Repeat same procedure on the contra-lateral 
side 8) Color Doppler: Color Doppler image with optimum sensitivity along with grayscale images. Shear 
Wave Measurements: 1) A total of 10 measurements  using  quantification  mode, with ROI  placed within 
the musculature in lateral mid abdomen 2) Elastography using Color   Map generation (two times in same 
region) within the musculature in lateral mid abdomen 3) Same measurements to be obtained for rectus 
abdominis muscle 4) Same measurements to be obtained for contralateral side Healthy volunteers will be 
thanked for their participation and subjects seeking ventral hernia repair return to their day and will 
eventually undergo standard treatment they would have otherwise done if they were not included in the 
study. Subjects who undergo ventral hernia repair will have followup care as per their standard treatment 
and information obtained through chart review regarding their medical course and surgical outcome/data 
(such as hernia defect size, if repair required components separation or mesh, complications ) will be 
included in the study analysis. Follow up Encounter: Subject who underwent surgical repair will also be 
asked to repeat the  exact  same  ultrasound evaluation at a standard follow up visit with their surgeon 
within six months of their hernia repair. 
 
The following documents are currently attached to this item: 
 
There are no documents attached for this item. 
 
Deception 
Does your project use deception? 
No 
 
Analysis Plan 
Analysis will include comparing shear wave velocity measurements between healthy subjects and subjects 
with ventral hernia as well as correlating these measurements with the surgical outcome/data among 
patients with ventral hernia. Further, we will compare the measurements taken in subjects who underwent 
hernia repair before and after the hernia repair. 
 
The following documents are currently attached to this item: 
 
There are no documents attached for this item. 

Page 14 of 16 
 
Are you conducting research outside of the United States? 
No 
 
Data confidentiality 
x Paper-based records will be kept in a secure location and only be accessible to personnel involved  
in the study. 
x Computer-based files will only be made available to personnel involved in the study through the 
use of access privileges and passwords. 
Prior to access to any study-related information, personnel will be required to sign statements 
agreeing to protect the security and confidentiality of identifiable  information. 
x  Wherever feasible, identifiers will be removed from study-related information. 
A Certificate of Confidentiality will be obtained, because the research could place the subject at risk 
of criminal or civil liability or cause damage to the  subject's  financial  standing, employability, or 
liability. 
A waiver of documentation of consent is being requested, because the only link between the  subject 
and the study would be the consent document and the primary risk is a breach of confidentiality. 
(This is not an option for FDA-regulated research.) 
Precautions are in place to ensure the data is secure by using passwords and encryption, because 
the research involves web-based surveys. 
Audio and/or video recordings will be transcribed and then destroyed to eliminate audible 
identification of subjects. 
 
Subject Confidentiality 
All computerized study databases will be housed on a secure Redcap database with deidentification 
capabilities. All information that is collected as part of this study will not be shared with other groups or 
investigators who are not part of the research team, except as required by the Institutional Review Board 
for the protection of human subjects. Further, data that is prepared for statistical analyses will be 
deidentified. Subjects are assigned uniques study IDs 
 
Sensitive Research Information* 
Does this research involve collection of sensitive information about the subjects that should be excluded 
from the electronic medical record? 
No 
 
Subject Privacy 
Privacy refers to the person's desire to control access of others to themselves. Privacy concerns people, 
whereas confidentiality concerns data. Describe the strategies to protect privacy giving consideration to 
the following: The degree to which privacy can be expected in the proposed research and the safeguards 
that will be put into place to respect those boundaries. The methods used to identify  and  contact potential 
participants. The settings in which an individual will be interacting with an investigator. The privacy 
guidelines developed by relevant professions, professional associations  and  scholarly  disciplines (e.g., 
psychiatry, genetic counseling, oral history, anthropology, psychology). 
Study discussion will take place in a closed room. Pregnancy test will be administered using a study ID 
number that will be assigned to participants. All data/images will be stored securely using study ID 
numbers. 
 
Data Disclosure 
Will the data be disclosed to anyone who is not listed under Personnel? 
De-identified data results may be published in peer-reviewed journals 

Page 15 of 16 
 
Data Protection* 
x Name 
Street address, city, county, precinct, zip code, and equivalent geocodes 
x All elements of dates (except year) for dates directly related to an individual and all ages over 89 
Telephone and fax number 
Electronic mail addresses 
Social security numbers 
x Medical record numbers 
Health plan ID numbers 
Account numbers 
Certificate/license numbers 
Vehicle identifiers and serial numbers, including license plate numbers 
Device identifiers/serial numbers 
Web addresses (URLs) 
Internet IP addresses 
Biometric identifiers, incl. finger and voice prints 
Full face photographic images and any comparable images 
Any other unique identifying number, characteristic, or code 
None 
 
Does your research request both a waiver of HIPAA authorization for collection of patient information 
and involve providing Protected Health Information ("PHI") that is classified as a "limited data set" 
(city/town/state/zip code, dates except year, ages less than 90 or aggregate report for over 90) to a recipient 
outside of the University of Pennsylvania covered entity? 
No 
 
Tissue Specimens Obtained as Part of Research* 
Are Tissue Specimens being obtained for research? 
No 
 
Tissue Specimens - Collected during regular care* 
Will tissue specimens be collected during regulator clinical care (for treatment or diagnosis)? 
No 
 
Tissue Specimens - otherwise discarded* 
Would specimens otherwise be discarded? 
No 
 
Tissue Specimens - publicly available* 
Will tissue specimens be publicly available? 
No 
 
Tissue Specimens - Collected as part of research protocol* 
Will tissue specimens be collected as part of the research protocol? 
No 
 
Tissue Specimens - Banking of blood, tissue etc. for future use* 
Does research involve banking of blood, tissue, etc. for future use? 
No 
 
Genetic testing 
If genetic testing is involved, describe the nature of the tests, including if the testing is predicative or 
exploratory in nature. If predictive, please describe plan for disclosing results to subjects and provision 

Page 16 of 16 
 
of genetic counseling. Describe how subject confidentiality will be protected Note: If no genetic testing 
is to be obtained, write: "Not applicable." 
Not applicable 
 
 
 
Consent 
1. Consent Process 
Overview 
Consent will be obtained in person with a written consent form in plain English before any imaging. 
Consent may obtained by any research personnel listed in the IRB. Only subjects capable of consent   will 
be included in the study. The consent process will inform the patient of the purpose of the study, study 
design, and possible risks and benefits of the study. Women of childbearing age will be ask to take a urine 
pregnancy test during the consent process. 
 
Children and Adolescents 
Not applicable 
 
Adult Subjects Not Competent to Give Consent 
Not applicable 
 
2. Waiver of Consent 
Waiver or Alteration of Informed Consent* 
No Waiver Requested 
 
Minimal Risk* 
Impact on Subject Rights and Welfare* 
Waiver Essential to Research* 
Additional Information to Subjects 
Written Statement of Research* 
No 
 
If no written statement will be provided, please provide justificiation 
 
 
The following documents are currently attached to this item: 
 
There are no documents attached for this item. 
 
 
Risk / Benefit 
Potential Study Risks 
Small risk for breach in PHI, measure are in place to prevent this. Small potential for incidental finding 
upon ultrasound imaging, measures are in place to prevent this (avoiding areas where such findings are 
common such as the gall bladder and other abdominal organs). 
 
Potential Study Benefits 
Each time the medical team has the opportunity to learn information so that we may better serve our 
patients, there is a direct benefit to the medical community 
 
Alternatives to Participation (optional) 
Potential subjects may choose not to participate in the study with no effect on their medical  care. 

Page 17 of 16 
 
Data and Safety Monitoring 
PI serves as study monitor 
 
The following documents are currently attached to this item: 
 
There are no documents attached for this item. 
 
Risk / Benefit Assessment 
There is a small risk of patient information breech and incidental ultrasound finding. Measures are in 
place to prevent these risks. 
 
 
 
General Attachments 
The following documents are currently attached to this item: 
Additional forms (responsetostipulations.docx) 
Additional forms (usconsenthipaaemrv2-clean.docx) 
Additional forms (usconsenthipaaemrv2-tracked.docx) 
Cover Letter (usherniairbcoverletter.docx) 
Additional forms (12november2015ideexemptionapproved.pdf) 
Investigator's brochure/product labeling (acuson_s3000_ultrasound_system_brochure-02428455.pdf) 
HIPAA Authorization or Waiver (usconsenthipaaemr.docx) 
Investigator's brochure/product labeling (siemensacusons3000.pdf) 
Investigator's brochure/product labeling (k152369.pdf)