The SAGES Manual of Hernia Repair

By Brian P. Jacob

The SAGES Manual of Hernia Repair will serve as a state-of-the-art resource for hernia surgeons and residents alike who are interested in the rapidly evolving area of abdominal wall hernia repair. This manual captures and summarizes the current trends in the field, as well as describing the new ideas, programs, and strategies regarding hernia repair. Through a unique section called Current Debates in Inguinal Hernia Repair, this volume also provides readers an overview of the current opinions on many of the ongoing debates of this time period. Furthermore, the manual is lavishly illustrated, containing an array of instructional charts and photographs, and is authored by a panel of experts in hernia repair.

Comprehensive and easily accessible, The SAGES Manual of Hernia Repair is a portable reference that will be of great value to all practicing surgeons and residents working in the field of abdominal wall hernia repair.

• Language: English
• Publisher: Springer
• Release date: Nov 13, 2012
• ISBN: 9781461448242

Book preview

Brian P. Jacob and Bruce Ramshaw (eds.)The SAGES Manual of Hernia Repair201310.1007/978-1-4614-4824-2_1© Springer Science+Business Media New York 2013

1. Establishing a Hernia Program and Follow-Up Regimen: A Complex Systems Design for Care and Improvement

Bruce Ramshaw¹  

(1)

Department of General Surgery, Transformative Care Institute, Advanced Hernia Solutions, Daytona Beach, FL, USA

Bruce Ramshaw

Email: [e-mail]

Abstract

The concept of establishing a hernia program has growing support within both the academic and private practice communities. There are, however, various ideas about how these programs should be implemented. This chapter will present a relatively new model for establishing a hernia program. It is based upon a complex adaptive systems approach. The core principles are care coordination with a team approach, together with continuous clinical quality improvement, defining and measuring outcomes, and adapting care processes to improve value for the patient’s entire cycle of care. This chapter will describe the implementation of a hernia program within a new academic medical center, designed in this complex adaptive system approach, and will describe how to potentially apply these principles within the community setting.

Keywords

Hernia programCare coordinationContinuous clinical quality improvementComplex adaptive systemsComplexity scienceComplex systems

It is tempting to write a chapter describing the development of a hernia program in the traditional center of excellence model. In that model, there would be criteria developed for certification, documented protocols, and standardized process and outcome measures reported to a national regulatory group. This has been the model for bariatric surgery programs for the past decade. However, there is growing awareness that this center of excellence model, while helping to prevent extremely poor care, actually fosters mediocrity and inhibits positive innovation. By implementing standards and static criteria as well as requiring resources focused upon reporting, attention is often placed on maintaining the status quo rather than on continuous learning and improving. The transformation to a sustainable health care system will require us to design programs around patient problems in a way that allows for continuous learning and improving, facilitated by a diverse community that includes the patient and family.

The center of excellence model is also designed either around a limited portion of a patient’s cycle of care and/or based on a particular physician specialty, rather than the entire cycle of care from the perspective of the patient. To understand why we need to evolve beyond the center of excellence model, it might be helpful to understand how our global health care system has become unsustainable in its current form. Our health care system has become what it is today through a complex history involving the evolution of hospitals, physicians, nurses, and other specialties, combined with insurance policies and other health care laws, enacted in an attempt to help people be able to afford and have access to health care. Over time, the health care system has grown to become almost 18% of the US GDP. A look at other developed countries’ spending on health care shows that, although they do not spend as much on total health care costs, the trends of increasing costs are essentially the same (Fig. 1.1). This represents a global health care system designed for the revenue growth of each part rather than for optimizing the value of the health of a population, including the entire patient cycle of care and the health care system itself. In addition to care givers and hospitals, a variety of industries within health care, led by the pharmaceutical industry, have grown to serve patients by providing diagnostic and therapeutic intervention and have also been successful in creating a large amount of wealth for a relatively small group of shareholders and top corporate executives. It is this fragmentation, with each part focused primarily on its own optimization, which has led to the current unsustainable situation in health care. [1, 2]

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Fig. 1.1.

Average health care spending per capita in many developed countries over a period of almost 30 years. Although the total spending per capita varies country to country, the overall spending trend over time (the slope) is similar for every country. This result reflects the predictable output of a complex system (our global health care system) where each part of the fragmented system is focused on revenue growth and profit margin (or bond rating for nonprofits). The system is producing the result (unsustainable costs) that it is designed to produce.

There are many other parts in the system that extract profit and resources which I will not describe (medical publishers, general purchasing organizations, etc.), but even with the few components mentioned, it is evident that the system inherently functions by attempting to optimize and protect its parts. Hospitals work to optimize hospital performance and maintain profit margin and growth targets; physicians focus on the financial needs of their individual and group practices as well as the portion of care they provide for the patient based on each physician’s specialty. In addition to these providers of care, pharmaceutical and other health care companies have a fiduciary responsibility to maximize shareholder profit while they are producing products to be used in patient care. An understanding of complex systems science makes it clear that when each part is attempting to optimize itself, then the whole process (in this case, the hernia patient’s entire cycle of care) WILL NOT be optimized [3].

Complex systems science also helps to explain why one type of treatment or device (such as hernia mesh) can be beneficial to one group of patients but cause harm to another. During the past decade, with the help of a dedicated hernia team and in collaboration with many hernia experts worldwide, we have discovered the complexity of mesh used to repair hernias, and just this one example is a reflection of the increasing complexity of the world, in general, and health care in particular. When I started residency (1989), there were basically a few meshes available, and today there are hundreds. Most importantly, the same mesh used with the same technique in two different patients can have significantly different outcomes. This variability is due to the fact that we are all (caregivers, patients, and the health care systems we function in) complex adaptive systems. The concept of complex systems means that outcomes are variable and dependent upon many variables, as well as the interactions between them. The design for organizations attempting to optimize the value of a complex system is very different from one that is designed to optimize the value of a simple system (in which the cause and effect are directly related and predictable—mass producing one type of hernia mesh, for example). For a simple system, the parts may be optimized to improve the entire process for a predictable, repeatable output. For a complex system, many parts may need to be suboptimized and all the interactions between the parts need to be managed, measured, and continuously improved. This allows for optimization of the whole process and output (providing care for a group of hernia patients, for example) [4].

Developing an Academic Hernia Program

The core concept behind the development of a hernia program using a complex systems approach is the design of the program with a new organizational structure. This must be one which provides person-centered care coordination with the implementation of continuous clinical quality improvement (CCQI) cycles. If these are developed as the essence of care delivery, it will drive increased value for both the patient and the system itself.

A core component of care coordination is the development of person-centered patient care managers. By facilitating patient and family member engagement and responsibility, the patient care managers ensure that an outcomes-based relationship is developed among the patient, their family, and the care team. With patient and family engagement, better decisions, better outcomes, and lower costs are more likely [5]. This patient and family relationship continues throughout the entire cycle of care for the patient, and of course, accountability is built into this important process.

The principles of care coordination and CCQI implementation include:

1.

Identify a diverse group of people to address the needs of a definable group of patients with hernia disease and hernia-related complications and problems. This will make up the core ­hernia team. Figure 1.2 represents the concept of a diverse team designed around the needs of a defined group of patients with hernia disease and related complications.

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Fig. 1.2.

An example of a diverse team built around a group of patients with hernia disease and hernia-related problems.

2.

Engagement and participation of patient and family in the care process, as a part of the hernia team and a part of the extended care community development (shared decision process for all elective care decisions).

3.

Continuous access to all information (patient record, dynamic care processes, outcomes, etc.) for the patient and family.

4.

Care coordination led by patient care managers who are considered and treated as equal members of the care team. This requires time to develop genuine relationships and trust between all core team members.

5.

Development of transparent, dynamic care processes based upon best available evidence and which are continuously improved, based on evolving evidence.

6.

Development of outcome measures that identify value of care for both the patient and the system: quality, satisfaction, safety, financial, etc.

7.

Care processes and outcome measures are developed and adapted to local environments and are continuously measured and improved through the CCQI process locally.

8.

The hernia team has the authority and resources to function within this complex systems structure and is accountable to make outcome measures transparent to governing boards made up of leadership and the community.

This plan addresses the system structural problem of why our health care system has not been able to evolve into a sustainable model, namely, the vertical department and hierarchical structure of most health care organizations in addition to the individual physician practice model. These system structures have led to fragmentation of care, and as complexity has increased, this fragmentation has led to poorer outcomes, less efficiency, and more waste within the entire health care industry. Recent attempts to improve quality, such as surgical site marking and timing of antibiotic dose in suspected pneumonia patients in the emergency room, have not led to significant improvement and, in some cases, have caused unintended harm [6–12]. Because these attempts are simple solutions applied to complex problems and complex systems, they do not provide significant or sustainable improvement. Addressing complex problems within complex systems requires a different approach.

In person-centered care, the focus is based upon defined patient groups and problems rather than upon the physicians’ specialties. The care is provided by diverse team members (including patients and family members) with the different skill sets necessary to effectively meet the needs of each patient group. For a person whose primary current problem is related to hernia disease, the hernia team provides integrated management for all care needs of the patient cutting across the traditional vertical department model. Integrated management of multiple comorbidities has been shown to improve outcomes [13, 14]. In CCQI, the cost of all steps of the health care process for patient groups are documented and analyzed, and the value is determined. This, in turn, is used to decrease the cost and waste as well as to improve the outcomes of care.

To effectively implement the CCQI process, an understanding of the patient processes associated with the entire cycle of care is necessary. These workflows document the patient steps, resources, data, and personnel associated with the care of the patient through the entire cycle of care. The care process begins with first contact with the patient and continues through the return to maximum quality of life, which may encompass the entire life span of the patient in some cases. One example of a dynamic patient care process is represented in Fig. 1.3.

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Fig. 1.3.

(a) The list and basic diagram for hernia program dynamic care processes representing all groups of patients cared for by our hernia program and the design of the care processes to define the patient’s entire cycle of care. (b) The early stages of developing a dynamic care process for a complex abdominal wall patient group. (c–f) A more complete example of the dynamic care process for a patient group with uncomplicated ventral hernia disease. Within many of these steps, there are data collection forms that will travel with the patient and team through the entire cycle of care and outcome measures that will be used to determine value and help to improve the process over time.

One challenge in determining the value for these processes is to determine the real costs for each step in each care process, termed activity-based accounting. In How to Solve the Cost Crisis in Health Care (Harvard Business Review, September 2011), Robert Kaplan and Michael Porter outline a process by which the value of health care is documented [15]. This involves determination of the true cost of care through a seven-step process: (1) determine patient population to be examined, (2) define the delivery care chain, (3) develop process maps of care delivery, (4) obtain time estimates for each step, (5) estimate the cost of supplying each patient care resource, (6) estimate capacity of each resource provider, and (7) compute the total costs over the entire cycle of care for a patient [15]. True costs of each step in the patient care cycle are determined, and value is also determined as part of the analysis. This data is critical for the analysis of the true value as measured by outcomes, satisfaction, and cost.

A critical aspect of all care is the technology involved in providing the care, including the medical records software (electronic medical records or EMR). The majority of medical and health record software used by hospitals is proprietary and expensive. This makes having different software systems and software systems that might be implemented in different areas of care difficult to integrate. Software users are locked into the interfaces and capabilities of the software and do not have the ability to customize the software to their specific needs. This makes it difficult to track the patient in a person-centered model and can contribute to medical error and increased costs [16]. As part of the Transformative Care Institute (our academic medical center designed in a complex system model), the Advanced Hernia Solutions team will design software around the care processes and outcome measurements in collaboration with the larger hernia care community. This software will be open source and freely available. It will be capable of interfacing with software that is currently in use within hospitals and health care systems using the protocols being developed as part of the health information exchange (HIE) effort.

In summary, the care team outlined in this chapter for an academic hernia program follows patients throughout their entire cycle of care. The team will provide local management for the care processes, measuring and being accountable for costs, quality, satisfaction, and other outcome measures throughout this entire care cycle. The data collected will allow for better decision making within this full cycle of care. An example of the use of CCQI and patient process documentation would be the selection of hernia mesh for hernia repair. Currently, there are no clear documented guidelines for the selection of hernia mesh. By being able to look at full patient cycles of care for multiple patients, better decisions in the selection of hernia mesh can be made. This can potentially reduce complications such as recurrence, chronic pain, and mesh infections which could require reoperation and removal of the mesh. Through the continuous learning and improvement of a CCQI model, the quality and satisfaction of care can be improved at the same time that the overall cost of care can be lowered. Because of the increasing complexity and pace of change in health care, and our world, this is a never-ending iterative process.

Adapting These Concepts to the Community Setting

It is clear that in a small private- or hospital-based practice, a general surgeon will not have the resources to implement a hernia program using the academic model described in this chapter. However, many of the principles of care coordination and continuous clinical quality improvement can be implemented over time. One goal of our hernia program is to develop software for hernia care processes that can be freely available to surgeons and hospitals. This software, which will be adaptable to the local environment, will help facilitate its implementation for hernia care. Until the software is available, surgeons who desire to be leaders of a hernia team can identify potential team members. These individuals might be current office staff, hospital employees, former patients, family members, or others within the community (several of our team members are former patients who volunteer their time). With a team identified, the dynamic care processes can be defined. These evidence-based care processes and outcome measures that determine value (quality, satisfaction, financial, etc.) will be the starting point for offering care to hernia patients in this model. When patients are cared for guided by these processes, the data that is generated can then be used to learn and to improve these processes.

There are a number of principles for implementing this locally. One of the most critical principles is to develop a true team environment. As a surgeon and leader of a hernia team, it will be necessary to cultivate a safe environment for the team in order to allow all team members to speak freely, without risk of being treated inferiorly. Clearly, each member of the team will have different levels of medical knowledge; however, each member’s perspective should be treated as valuable. The ability for all members of the team to speak up can have significant benefits for patient safety and opportunities for innovation. The patient and family perspectives are especially important because of the unique experience of actually going through the cycle of care. It is important to have an open mind and be driven by the outcomes rather than preconceived beliefs. This will not necessarily be easy and will take time.

Another important principle is to not make reactionary decisions. If the first time a new mesh is used and the patient has a recurrence, it is not necessarily a bad mesh. There might be technical issues (learning curve with a new product), patient selection issues, or other factors that generated a poor outcome. Looking at the outcomes with the team will help to prevent reactionary decisions. Most importantly, whatever decisions are made to change processes, they should be measured by looking at the outcomes after the process change has been made.

The following steps can be used to implement a hernia program:

1.

Identify a core team.

2.

Define dynamic care processes and outcome measures – the types of hernia patients your program will care for, procedure to offer, and types of patients and hernia complications (such as chronic pain after hernia repair) your program will refer (it will be helpful to identify appropriate surgeons and other hernia programs to which the team can refer patients that your hernia program decides not to care for).

3.

Begin to see patients in this hernia program model—allow patients to view the processes and outcomes as they are generated to help them make decisions throughout their cycle of care (shared decision process).

4.

Generate outcomes data and identify errors, complications, and anomalies (good and bad) during the patients’ cycle of care.

5.

Have regular team meetings to review these outcomes and look for opportunities to improve the care processes. These CQI meetings have replaced traditional M&M conference at our new academic medical center.

6.

Develop and support extended team members (in the OR, on the floor, etc.) and care communities (former patients and others interested in your hernia program) that can help support the care coordination and continuous learning and improving which are the foundations of this model for hernia care.

7.

Have fun! Building a team and a community that cares for each other can be an incredibly rewarding experience. When implemented, this model has the potential to not only improve the value of patient care but also improve the working environment and behavior of the entire care team.

Summary

The decision to implement a hernia program should be made as a commitment to care for patients with hernia problems. No hernia program, ours included, can serve all hernia patients and provide every option for care. It will be important to identify a core hernia team and define the care processes that your team will offer to patients. These care processes should be evidence-based. Outcome measures should be identified and collected that will determine the value of care provided. These will need to be measured not only for a portion of care but also for the entire cycle of care. Applying continuous learning and clinical quality improvement principles will ensure that the care provided by your program will generate better outcomes and better value over time.

References

1.

Elhauge E, editor. The fragmentation of the US health care system: causes and solutions. New York: Oxford University Press, Inc.; 2010.

2.

Stange K (ed) The problem of fragmentation and the need for integrative solutions. Ann Fam Med. 2009;7(2):100–3.

3.

Breen AM, Burton-Houle T, Aron DC. Applying the theory of constraints in health care: Part 1 - The philosophy. Qual Manag Health Care. 2002;10(3):40–6.PubMed

4.

Plsek P, Greenhalgh T. The challenge of complexity in health care. BMJ. 2001;323:625–8.PubMedCrossRef

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Weinberg DB, etal. Beyond our walls: impact of patient and provider coordination across the continuum on outcomes for surgical patients. Health Serv Res. 2007;42(1):7–24.PubMedCrossRef

6.

Welker J, Huston M, McCue J. Antibiotic timing and errors in diagnosing pneumonia. Arch Intern Med. 2008;168(4):351–6.PubMedCrossRef

7.

Hawk MT, et al. Surgical site infection prevention time to move beyond the surgical care improvement program. Ann Surg. 2011;254:494–501.CrossRef

8.

Stahel PF, et al. Wrong-site and wrong-patient procedures in the universal protocol era. Arch Surg. 2010;145(10):978–84.PubMedCrossRef

9.

The NICE-SUGAR Study Investigators. Intensive versus conventional glucose control in critically ill patients. N Engl J Med. 2009;360:1283–97.CrossRef

10.

Pines J, Isserman J, Hinfey P. The measurement of time to first antibiotic dose for pneumonia in the emergency department: a white paper and position statement prepared for the American Academy of Emergency Medicine. J Emerg Med. 2009;37(3):335–40.PubMedCrossRef

11.

Nicholas L, et al. Hospital process compliance and surgical outcomes in medicare beneficiaries. Arch Surg. 2010;145(10):999–1004.PubMedCrossRef

12.

Drake D, Cohen A, Cohn J. National hospital antibiotic timing measures for pneumonia and antibiotic overuse. Qual Manag Health Care. 2007;18(2):113–22.

13.

Bogner H, et al. Integrated management of type 2 diabetes mellitus and depression treatment to improve medication adherence: a randomized controlled trial. Ann Fam Med. 2012;10(1):15–22.PubMedCrossRef

14.

Edgren L. The meaning of integrated care: a systems approach. Int J Integr Care. 2008;8:e68.PubMed

15.

Kaplan RS, Porter ME. How to Solve the Cost Crisis in Healthcare. Harv Bus Rev. 2011;89(9):46–52.PubMed

16.

Black AD, et al. The impact of eHealth on the quality and safety of health care: a systematic overview. PLoS Med. 2011;8(1):e100387. doi:10.1371/journal pmed.100387.CrossRef

Brian P. Jacob and Bruce Ramshaw (eds.)The SAGES Manual of Hernia Repair201310.1007/978-1-4614-4824-2_2© Springer Science+Business Media New York 2013

2. Prosthetic Choice in Open Inguinal Hernia Repair

Lisa C. Pickett¹  

(1)

Departments of Surgery/Critical Care and Medicine, Duke University Hospital, Durham, NC, USA

Lisa C. Pickett

Email: [e-mail]

Email: [e-mail]

Abstract

Modern open inguinal hernia repair is generally performed with prosthetic mesh. The quantity of types of mesh available for repair has greatly increased in the past few years, to include porous, nonporous, absorbable, and biologic mesh. Each mesh carries with it a profile of characteristics to address patient anatomy and clinical setting in the overall context of surgeon choice.

Keywords

Open inguinal hernia repairInguinal hernia repairProsthetics in open inguinal hernia repairShouldice repairHernia mesh

While non-mesh repairs can be performed safely in experienced hands with standardized technique, such as the Shouldice (1), tension-free repairs with mesh placement have become the gold standard for the open repair of inguinal hernias (2). Traditionally, there has been concern about the placement of mesh in an acute/incarcerated hernia, but this appears to be safe (3), even in the context of bowel necrosis (4). Internet search of hernia mesh reveals countless brands and types of mesh for the repair of inguinal hernias. Mesh materials vary by source. There are absorbable and permanent synthetic meshes, allograft material, and xenograft material. In addition, mesh is sold in flat sheets, precut segments, and three-dimensional forms. Some mesh products include additional components to resist adhesions, to allow for fixation, or to prevent infection.

Webster’s dictionary defines mesh as that which entangles us (5). This is not truer than in inguinal hernia repair. Millions of inguinal hernia repairs are performed in the world annually, predominantly open, with every variety of prosthetic, from polyester and polypropropylene to mosquito netting in some parts of the world (6). In fact, a recent study demonstrates no significant difference in outcomes between sterile mosquito nets and standard commercial mesh, which cost 1,000 times more! (7)

History

Initial management of inguinal hernias required external management with bandages, then trusses, first created by French surgeon Guy de Chauliac and then by Ambroise Pare, and subsequently a variety of plugs to occlude the internal ring (8). Surgical intervention was first performed by Bassini, without any prosthetic, in 1884. The Bassini repair was documented with 2.6% mortality and 3.1% recurrence in 227 patients with 98% follow-up at 4.5 years (9). As experience with this procedure widened, a variety of types of wire and suture were utilized to reinforce the abdominal wall (10). Subsequently, early forms of mesh were created and implanted. These consisted of stainless steel, which was too stiff; nylon, which disintegrated too rapidly; and then polypropylene (11–13). At this point, mesh was simply used to buttress or reinforce suture repairs.

Mesh Utilized in Tension-Free Repairs

Usher was the first to introduce significant changes in the conceptual repair of hernias, utilizing mesh to bridge the hernia gap, instead of just buttress a repair performed under tension. Thus, the first description of a tension-free hernia repair was presented: If mesh is used to bridge the defect instead of reinforcement for tissues approximated under stress, this factor of tension is eliminated, and recurrence becomes less likely (14). The next mission was to identify the ideal location to place the mesh. Irving Lichtenstein performed and presented an updated tension-free hernia repair with mesh placed anterior to the transversalis fascia in 1980, and this Lichtenstein repair has become accepted as a standard hernia repair which is simple to perform, can be safely conducted under local anesthesia, and has acceptable rates of complication and time for recovery (15–17).

Preperitoneal Mesh

The main concern of these repairs remained the forces of abdominal pressure on that location of mesh placement. There was a concern that these forces increase the risk of recurrence for mesh placed anterior to the fascia, instead of the preperitoneal location. Thus, a line of repairs was proposed for mesh placed in the preperitoneal location, either via laparoscopic placement or through open repair (18–20).

A subset of these repairs also includes a prosthetic inserted into the internal ring, either alone or with a hernia patch, to help prevent recurrence (21, 22) (Fig. 2.1). Plugs can be visualized via laparoscopy or CT scan. Radiographically, it appears as a smooth round or oval hypodense mass close to the inferior epigastric artery, confirming the importance of radiologist’s knowledge of past surgical history when reviewing scans (23). There are multiple reports of mesh migration from the intended location, including a case report of intraperitoneal migration of a mesh plug with a small intestinal perforation (24).

To address this risk, in 1998, Gilbert and Graham introduced a double-layered device, which sits in the inguinal defect, combining a small plug with both a subaponeurotic component and preperitoneal patch, all formed of polypropylene. This mesh is called the Prolene Hernia System (PHS). The PHS incorporates the goal of decreased suture placement with mesh placed in the preperitoneal location. The material is polypropylene and placed via open technique (25). Results have been evaluated and demonstrate 1% recurrence and 2% chronic pain with a mean follow-up of 49 months (26). Longitudinal follow-up has demonstrated 2.3% recurrence and 1.8% chronic pain at 5.5 year follow-up. (27) Comparison of flat polypropylene mesh and PHS at 1 year demonstrates that the PHS surgery takes 15 min longer, on average, and there was no difference in pain, return to activity, complication, or recurrence. (28)

Nonabsorbing synthetic mesh is available in ePTFE (Gortex®), which is seldom used in the groin, and porous sheets such as polypropylene, polyester, and Ultrapro. Porous mesh is further divided into light-, medium-, and heavyweight mesh, based upon the density of the mesh fibers.

Lightweight mesh has been compared with heavyweight, and the recent data has demonstrated some benefit in lightweight mesh. Lightweight mesh has been shown to result in reduced chronic groin pain at the operation site, although there was no associated increase in quality of life in one study (29). In a separate study, reduced postoperative pain and recurrence in the short term was found but there was no statistical difference in recurrence rate at longer-term follow-up (30). Mesh can also be combined with absorbable elements to create ultralightweight mesh, such as Ultrapro®. A literature search was performed using Medline, Embase, and Cochrane databases to identify relevant randomized controlled trials, and comparative studies looked at long-term complications of prosthetic meshes, specifically comparing partially or completely absorbable meshes with conventional nonabsorbable mesh. The primary outcomes reviewed included hospital stay, time taken to return to work, seroma, hematoma, wound infection, groin pain, chronic pain, foreign body sensation, recurrence, and testicular atrophy. It was concluded that absorbable and nonabsorbable mesh repairs of inguinal hernias do not afford significant benefit, but lightweight mesh was associated with a significant reduction in prolonged pain and foreign body sensation. (31) An additional meta-analysis reviewed Vypro II (large pore) and standard polypropylene mesh for inguinal hernia repair, looking at recurrence, pain, urinary tract infection, seroma, foreign body sensation, and testicular atrophy. This analysis found a difference only in the sensation of a foreign body, which was reduced in the large-pore mesh (32).

Self-Fixation Mesh

A more recent addition has been mechanisms of self-fixation to avoid the placement of sutures, which have been implicated in increased pain (Fig. 2.2). A randomized study of self-fixing mesh demonstrates decreased operative time, decreased pain postoperative day 1 by visual analog pain score, and decreased cumulative dose of postoperative pain medicine over standard mesh secured with sutures. (33) Another similar study that assessed pain after the use of a self-adhesive, light mesh with reduced sutures demonstrates reduced early postoperative pain compared with conventional prosthesis (34) and a rat model with similar mesh demonstrates no harmful influence on the ductus deferens in the rat model (35).

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Fig. 2.1.

Self fixation mesh.

Absorbable Mesh

Synthetic mesh is available as an absorbable prosthetic for use in highly contaminated situations. Vicryl® and Dexon are examples of this type of mesh. These products remain intact for just a few weeks and, therefore, are associated with high recurrence rates and are, therefore, generally reserved for grossly contaminated cases.

Biologic Mesh

Biologic mesh is available for patients who are at high risk of infection. Allografts, including Alloderm®, have limited experience and use in the groin. Xenografts are biologics derived from nonhuman dermis, often bovine or porcine. They are harvested cells, essentially an acellular collagen, supported by chemical processes for stabilization. Permacol mesh and Surgisis mesh are examples of xenografts. Additional biologics have been studied (36), but there is little human data and no long-term human outcomes available. As in all prosthetics, allergies and religious and cultural beliefs need to be taken into consideration in the surgical placement of biologic products.

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Fig. 2.2.

Plug, removed for chronic pain.

Data on outcomes of hernia repair relative to type of mesh are available in terms of ease of use, durability/recurrence, and long-term chronic pain. See Table 2.1 for a summary of advantages/disadvantages of each mesh type.

Table 2.1.

Advantages/disadvantages of each mesh type.

In final summary, there are innumerable types, shapes, and compo­nents of mesh. Each carries a unique profile of benefits and risks. There is short-term data suggesting better surgeon ease of placement and reduced pain with both lightweight and self-fixation meshes. Long-term results remain unchanged, and biologic grafts remain relatively unstudied. It would seem that surgeons should select a mesh which they feel comfortable placing, place these meshes consistently to improve their comfort with the devices, and follow these patients prospectively for outcomes. It is likely that in this complex field, there is not one right mesh for each patient.

References

1.

Shouldice EE. The treatment of hernia. Ontario Med Rev. 1953;20:670.

2.

Scott NW, McCormack K, Graham, P et al. Open mesh versus non-mesh for repair of femoral and inguinal hernia. Cochrane Database Syst Rev. 2002;CD002197

3.

Nieuwenhuizen J, van Ramshort GH, Ten Brinke JG, de Wit T, van der Harst E, Hop WC, Jeekel J, Lange JF. The use of mesh in acute hernia: frequency and outcome in 99 cases. Hernia. 2011;15(3):297–300.PubMedCrossRef

4.

Atila K, Guler S, Inal A, Sokmen S, Karademir S, Bora S. Prosthetic repair of acutely incarcerated groin hernias: a prospective clinical observational cohort study. Langenbecks Arch Surg. 2010;395:563–8.PubMedCrossRef

5.

Merriam-Webster. Webster’s Dictionary. Springfield, MA; 2000

6.

Shillcutt SD, Clarke MG, Kingsnorth AN. Cost-effectiveness of groin hernia surgery in the Western Region of Ghana. Arch Surg. 2010;145:954–61.PubMedCrossRef

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Brian P. Jacob and Bruce Ramshaw (eds.)The SAGES Manual of Hernia Repair201310.1007/978-1-4614-4824-2_3© Springer Science+Business Media New York 2013

3. Prosthetic Choice in Laparoscopic Inguinal Hernia Repair

Emily L. Albright¹ and J. Scott Roth²  

(1)

Division of General Surgery, Department of Surgery, University of Kentucky College of Medicine, Lexington, KY, USA

(2)

Department of Surgery, University of Kentucky College of Medicine, Lexington, KY, USA

J. Scott Roth

Email: [e-mail]

Abstract

Inguinal hernia repair is one of the most common procedures performed by a general surgeon. The management of inguinal hernias has undergone many changes in the last five decades. The advent of prosthetic materials has decreased the recurrence rate compared to primary repair. The age of laparoscopy has brought new techniques with well-defined benefits including a reduction in pain, lower wound infection rates, and a shortened return to normal activities. With all these advances have come many choices for the practitioner today regarding prosthetic materials that differ in terms weight, burst strength, material composition, and inflammatory response. This chapter aims to examine the different prosthetics available and delineate their benefits and shortcomings, specifically relating to laparoscopic inguinal hernia repair.

Keywords

Laparoscopic inguinal hernia repairProsthetic choiceMesh

Inguinal hernia repair is one of the most common procedures performed by a general surgeon. The management of inguinal hernias has undergone many changes in the last five decades. The advent of prosthetic materials has decreased the recurrence rate compared to primary repair [1]. The age of laparoscopy has brought new techniques with well-defined benefits including a reduction in pain, lower wound infection rates, and a shortened return to normal activities [2–4]. With all these advances have come many choices for the practitioner today regarding prosthetic materials that differ in terms of weight, burst strength, material composition, and inflammatory response. This chapter aims to examine the different prosthetics available and delineate their benefits and shortcomings, specifically relating to laparoscopic inguinal hernia repair.

Synthetic Overview

Prosthetic materials were developed to reinforce hernia repairs and prevent recurrence. The three most common synthetic prosthetics used today are polypropylene, polyester, and PTFE, and they were all developed at roughly the same time. Polyester polymers were first introduced in the United States in 1946; in 1956, Wolstenholme described the use of polyester to repair inguinal hernias [5]. Polypropylene is the most commonly used prosthetic in the United States following its introduction in 1958 by Usher [6]. At the time of its introduction, there were many advantages over the metal meshes that were currently in use. It had a high tensile strength, was less affected by infection, and was infiltrated by connective tissue when implanted into an animal model. Just 4 years after its introduction, polypropylene was being used by 20% of surgeons for complicated hernia repair [6]. Polytetrafluoroethylene (PTFE) was initially developed by DuPont in 1938 and began to be used in hernia repair in the 1950s. In the 1960s, a process was developed to expand PTFE to produce a uniform structure with improved mechanical strength (ePTFE) [6]. This ePTFE was used not only for abdominal wall reconstruction but also for vascular grafts. When laparoscopic inguinal hernia repair was developed, technology had already made multiple alterations to the three basic polymers—polypropylene, polyester, and PTFE. They each have separate chemical structures and handling properties. It is these differences in texture and porosity that lead to differences in tissue reaction.

Polypropylene

Polypropylene is a thermoplastic polymer consisting of an ethylene with an attached methyl group (Fig. 3.1). It is hydrophobic, electrostatically neutral, and resistant to significant biologic degradation. The biologic reactivity of polypropylene depends on the weight, filament size, pore size, and architecture, in addition to the individual host response. Not all polypropylene prosthetics are equal as structure can alter outcome. In one study comparing various polypropylene, they found that patients with a monofilament polypropylene took significantly longer to return to work, had higher pain scores, and more impairment in everyday activities compared to patients that had a multifilament polypropylene [7]. By utilizing knitted versus woven materials, the flexibility can also be altered [8]. Pore size is also variable between different manufacturers. Pores should be at least 75–100 μm to prevent against infection [9].

A214970_1_En_3_Fig1_HTML.gif

Fig. 3.1.

Polypropylene.

Current debate exists regarding the optimal density of polypropylene. Normal intra-abdominal pressure ranges from 1.8 mmHg when supine up to 171 mmHg when jumping [10]. Laboratory data indicates that a prosthetic should withstand at least 16 N/cm strain to prevent disruption based on normal physiologic forces [11]. Many of the original polypropylene prosthetics provide much greater strength than this. Heavyweight meshes were designed to provide maximal strength with thick fibers, small pores, and a high tensile strength. Prosthetic materials have also been found to be inappropriately stiff when compared to the normal elasticity of the abdominal wall [11]. Based on this, there has been a move to decrease the density of polypropylene implanted to provide adequate strength while reducing the amount of foreign material.

One outcome that is of particular interest is the effect of the use of lightweight mesh has on postoperative pain. Proponents of lightweight mesh cite less pain and less mesh sensation as benefits. However, this has not been universally seen in all studies. One study in particular compared lightweight polypropylene mesh with a heavyweight polypropylene mesh in patients undergoing laparoscopic bilateral inguinal hernia repair [12]. Lightweight polypropylene was placed in one groin and heavyweight in the contralateral groin. They found that patients could detect a difference and reported less pain on the side with the lightweight polypropylene. In contrast, a comparison of patients undergoing laparoscopic inguinal hernia repair with either a lightweight or heavyweight mesh was published just 1 year later. This study did not find a difference in pain or discomfort at 4- or 15-month follow-up between lightweight and heavyweight prosthetics. They also did not show a difference in awareness of the mesh or stiffness of the groin [13]. There are many more studies comparing lightweight mesh to heavyweight mesh. Some demonstrate an improvement in postoperative pain [14–17]. However, not all series show this difference [18].

While long-term pain and pain in the early postoperative period are important to consider when considering a prosthetics, long-term durability and hernia recurrence are equally important. Many of the opponents to lightweight prosthetics express concern for increasing recurrence. In one study, at 12-month follow-up of open inguinal hernia repair, there was a significant increase in recurrence in patients with a lightweight polypropylene mesh compared to traditional polypropylene [16]. Multiple other studies fail to demonstrate an increased recurrence rate [14, 15, 17]. When lightweight mesh is used specifically for laparoscopic inguinal hernia repair, no difference in hernia recurrence was identified [12, 13, 18]. Whether the concern for an increase in hernia recurrence is justified remains to be seen as long-term follow-up continues.

Polyester

Polyester is a category of polymers that contain an ester in the main chain (Fig. 3.2) and has many applications in daily life, from clothing to jet engines. While polypropylene is used extensively for hernia repair, polyester is also commonly used. Multiple studies exist comparing these two materials. One study compared patients that had previously undergone laparoscopic inguinal hernia repair either with polypropylene or polyester prosthetic [19]. A phone survey was conducted on patients with a minimum of a 1-year follow-up with questions focused on pain, perception of the mesh, return to work, and satisfaction. In this study, there was an increase in chronic inguinal pain, feeling of a lump, and feeling the mesh in the polypropylene group compared to the polyester group. There was no difference in recurrence rate. Another study citing the benefits of polyester prosthetics was in a series of 337 patients undergoing laparoscopic inguinal hernia repair with polyester mesh [20]. After a mean follow-up of 11 months, there were no recurrences, no mesh infections, and chronic pain in three patients. Despite multiple studies, there exists no clear benefit of polypropylene versus polyester, and choice remains based on surgeon preference.

A214970_1_En_3_Fig2_HTML.gif

Fig. 3.2.

Polyester.

One concern regarding the use of polyester prosthetics is the degradation that occurs over time. In one study examining explanted polyester vascular grafts, there was hydrolytic degradation of the grafts with increasing time implanted [21]. Further analysis showed that polyester grafts lost 31.4% of their burst strength at 10 years and 100% in 25–39 years. The earliest graft failure in this study was after 19 years. If the same is true of polyester grafts for inguinal hernia repair, this clearly would not be a problem for an inguinal hernia repair in a 90-year-old patient but would affect an 18-year-old patient.

Polytetrafluoroethylene

Polytetrafluoroethylene is a synthetic polymer of tetrafluoroethylene consisting of carbons and fluorines with multiple applications (Fig. 3.3). It is most well-known by the brand name Teflon and can be found as a nonstick coating for pans, a lubricant in gears, and a roofing material. In the medical profession, PTFE is used for hernia repair as well as in vascular grafts.

A214970_1_En_3_Fig3_HTML.gif

Fig. 3.3.

Polytetrafluoroethylene.

With the increasing usage of polypropylene and polyester prosthetics, PTFE is not used as frequently for inguinal hernia repair. However, when laparoscopic techniques were first introduced for inguinal hernia repair, PTFE prosthetics played a key role in intraperitoneal onlay mesh repair (IPOM). Results of a prospective study looking at the ePTFE peritoneal onlay laparoscopic inguinal hernioplasty were published in 1996 [22]. Over a period of 2.8 years, 351 patients underwent repair. They found that on average patients only required 24 h of analgesics, returned to work in 7.7 days for unilateral repairs, and returned to work in 10.1 days for bilateral repairs. There were 13 patients in the series with persistent neuralgia and 17 patients with recurrences (3.8%). Another prospective trial comparing IPOM with ePTFE to an open repair reported an even higher recurrence rate of 43% [23]. It is likely that these recurrence rates contributed to the decline in the use of PTFE for laparoscopic inguinal hernia repair.

In addition to the concern for hernia recurrence is the risk of infection associated with the use of PTFE. When the pore size of a prosthetic is less than 10 μm, macrophages and neutrophils are too large to enter and cannot eliminate bacteria [24]. When PTFE does become colonized, removal is mandatory in order to manage the infection. The small pore size of PTFE also impacts the formation of postoperative seromas. There is insufficient molecular permeability for fibrinous and proteinaceous materials to be cleared [24].

Barrier Prosthetics and Composite Prosthetics

In addition to prosthetics that are pure synthetic material or pure biologic material, there are a variety of prosthetics that combine various materials. One example is beta-glucan-coated polypropylene prosthetics. Beta-glucan is a plant product that is used to promote healing and also has an immunomodulatory effect. In published series, using beta-glucan-coated polypropylene resulted in a decrease in the incidence of chronic pain compared to polypropylene alone and a low incidence of recurrence at 2 years (1.9%) [25, 26].

Other prosthetics combine permanent material with a barrier layer to prevent adhesions to one side. This type of prosthetic is particularly useful if the peritoneum has been violated and is not available to separate the prosthetic from intra-abdominal contents. Barriers can be placed on one side or both sides of the mesh. Typically, the barrier layer is designed to allow adequate time for a neo-peritoneum to develop prior to their degradation. The previously mentioned prosthetics, including polypropylene, polyester, lightweight and heavyweight, all have an alternative with a barrier layer. The majority of the data regarding prosthetics with a barrier layer focuses on their use in ventral hernia repair where they are more likely to be intact with intra-abdominal contents.

In an effort to decrease the amount of permanent foreign material, composite materials have been developed that combine polypropylene with absorbable materials. One example is a composite mesh of polypropylene with polyglactine. While the polypropylene is permanent, the polyglactine fibers are resorbed in approximately 60 days. In studies comparing polyglactine-polypropylene composite with polypropylene alone in open inguinal hernia repair, there was no difference in perioperative complications, postoperative pain, or recurrence [27–29]. These results were similar when polyglactine-polypropylene was compared to polypropylene alone in laparoscopic inguinal hernia repair with no difference in pain, return to normal daily activities, and recurrence [7, 30–32]. Polyglactine-polypropylene is smoother than polypropylene and thus has different handling characteristics. However, this does not translate into a difference in operating times or subjective assessment of difficulty of mesh placement [31].

In addition to polyglactine, there are other alternatives to an absorbable component combined with polypropylene. One such example is polyglecaprone 25. When polypropylene was compared to a polyglecaprone 25-polypropylene composite in an animal model, there was a decrease in the inflammatory and fibrotic reaction; however, it was not statistically significant [33]. As we search for the optimal mesh, there are likely to be more combined prosthetics developed in addition to those mentioned here.

Prosthetics have also been altered to decrease the need for fixation. One example is a polypropylene mesh with a nitinol frame [34]. Another example is a titanium-coated monofilament polypropylene mesh that has been shown to have a recurrence rate of 0.4%, persistent inguinal pain in 3.8%, and groin stiffness in 1.7% after a 7-week follow-up [35].

As humans are two-dimensional structures, there has been an effort to manufacture prosthetics that conform to the contours of the human body and avoid the need for fixation. One study looking at mesh fixation showed it to be associated with a longer hospital stay and more narcotic analgesia requirements [36]. In a retrospective review of 212 transabdominal pre-peritoneal herniaplasties using a three-dimensional mesh, 94% of patients had returned to normal activities by 3 weeks. Mesh fixation was used in 19% of the cases in this series. They did not find that bilateral repair or fixation altered recovery. Only four patients in the series had minor pain or numbness. With a mean follow-up of 23 months, there was only one recurrence. They concluded that an anatomically contoured prosthetic had minimal risk of neuropathy, had a low recurrence rate, and often does not require fixation [37]. A second series looking at an anatomically contoured prosthetic in 390 patients had similar results [38]. At 2 years, there were three recurrences, and 43 patients reported minor parietal pain.

Biologic Prosthetics

Biologic prosthetics are designed as either allografts (from human tissue) or as xenografts (from animal tissue). Available animal products are porcine and bovine. In addition to what species a biologic material is from, they also differ on what part is harvested, including dermis, small intestinal submucosa, and pericardium. The role of biologic materials in any hernia repair has mainly been limited to infected surgical fields. For laparoscopic inguinal hernia repair, there exists limited data examining the role of biologic prosthetics, and research examining their role is ongoing. Recently, the design of a study comparing the use of lightweight polypropylene to cross-linked porcine dermis was published [39]. Currently, 172 men are enrolled in the study, and data are being collected. Other studies have focused on the feasibility of using biologic prosthetics for inguinal hernia repair [40–42].

There are concerns regarding the use of biologic prosthetics for laparoscopic inguinal hernia repair, namely, the risk of recurrence. For laparoscopic inguinal hernia repair, all prosthetics are placed in a bridging manner. In incisional hernia repair, when biologic prosthetics are used in a bridging manner, there is an 80% recurrence rate [43]. In this study, there is no comment on size of hernia defect, but generally incisional hernias have a larger defect size than inguinal hernias. The risk of recurrence