- Email: [email protected]
Open ventral hernia repair using ProGrip™ self-gripping mesh
Accepted Manuscript Open ventral hernia repair using progrip™ self-gripping mesh Steven B. Hopson, Larry E. Miller PII:
S1743-9191(15)01258-3
DOI:
10.1016/j.ijsu.2015.09.069
Reference:
IJSU 2262
To appear in:
International Journal of Surgery
Received Date: 8 July 2015 Revised Date:
16 September 2015
Accepted Date: 26 September 2015
Please cite this article as: Hopson SB, Miller LE, Open ventral hernia repair using progrip™ self-gripping mesh, International Journal of Surgery (2015), doi: 10.1016/j.ijsu.2015.09.069. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
ACCEPTED MANUSCRIPT
OPEN VENTRAL HERNIA REPAIR USING PROGRIP™ SELF-GRIPPING MESH Steven B. Hopson, MD, FACSa, Larry E. Miller, PhDb
Bon Secours TPMG Hernia Center, 860 Omni Boulevard, Suite 204, Newport News, VA,
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a
23606, USA; [email protected] b
Miller Scientific Consulting, Inc., 1854 Hendersonville Road, #231, Asheville, NC, 28803,
Steven B. Hopson, MD, FACS Bon Secours TPMG Hernia Center 860 Omni Boulevard, Suite 204
Phone: +01 (757) 846 4335
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Newport News, VA 23606, USA
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Corresponding author
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USA; [email protected]
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Email: [email protected]
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Running title: Self-gripping mesh for open ventral hernia repair
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Abstract
Purpose: Secure mesh fixation in incisional hernia repair is mandatory to prevent mesh
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dislocation and possible recurrence. Traditional fixation methods have been implicated as a source of chronic postoperative pain. We report 2-year outcomes with a self-gripping mesh for open tension-free repair of large incisional hernia.
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Methods: This prospective case series enrolled 20 patients with large primary incisional hernia (mean defect size: 84 cm2). Patients were electively treated by a single surgeon using a
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macroporous polyester mesh with resorbable polylactic acid microgrips (ProGrip™, Covidien, Mansfield, MA, USA) using open onlay technique. Main outcomes included pain severity, Carolinas Comfort Scale (CCS), complications, and hernia recurrence. Patients returned for follow-up at 1, 3, 6, 12, and 24 months.
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Results: Median mesh fixation time was 2 minutes. Mean operative time was 38 minutes and blood loss was minimal (50 cc). Most patients (75%) were discharged same day. The only perioperative complication was a minor seroma in one patient. Patient follow-up compliance
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through 2 years was 100%. Mean pain score was 1.8 at discharge, 0.9 at 1 month, 0.7 at 1 year, and 0 at 2 years. At 2-years, all patients were “very satisfied” with treatment and hernia-specific
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quality of life was excellent (mean CCS score=0). No infection, mesh removal, or hernia recurrence occurred during follow-up. Conclusions: Open repair using a self-gripping mesh is a viable treatment option in patients with large incisional hernia. Immediate mesh fixation facilitates a safe and durable tension-free repair.
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Keywords: incisional hernia, mesh, ProGrip, recurrence
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1.0 Introduction Incisional hernia is a common complication of abdominal surgery that contributes to chronic pain, decreased quality of life, and significant healthcare costs 1,2. In some cases, incisional
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hernia results in serious complications such as incarceration or strangulation that require prompt reduction in order to prevent bowel ischemia. Although numerous direct suture repair techniques have been described in the literature, recurrence remains common with rates ranging from 39%
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to 49% 3-5. Mesh repair lowers the long-term risk of recurrence by approximately 50% compared to suture repair 6. Consequently, the use of mesh to reinforce incisional hernia repair has become
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standard of care at most centers although the preferred operative method 7, mesh type 8, and mesh positioning 9 remain controversial topics. The etiology of recurrence and chronic postoperative pain is multifactorial and may be related to mesh placement technique, mesh type, or mesh fixation method. Continued refinements in surgical technique and mesh technology are
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mandatory to identify the ideal treatment algorithm in incisional hernia repair.
A novel self-gripping mesh (ProGrip™, Covidien, Mansfield, MA, USA) has been developed to
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achieve secure, long-term abdominal wall reinforcement without the need for additional permanent fixation. Promising clinical outcomes have been reported with this mesh in inguinal
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hernia repair 10,11. However, its use in incisional hernia repair is more limited. A case series of 21 patients with incisional hernia (4-6 cm) treated with open repair using ProGrip mesh reported excellent outcomes through 6 months follow-up 12. However, no published series have investigated the use of this mesh in patients with larger incisional hernia, a major risk factor for recurrence 13. Additionally, no known reports have described long-term outcomes with onlay repair of large incisional hernias. Therefore, the purpose of this study was to report 2-year
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outcomes in patients treated with a self-gripping mesh for tension-free onlay open repair of large incisional hernias.
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2.0 Methods
2.1 Patients
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All research performed in this study was in strict accordance with a common, pre-defined
protocol that was approved by a local institutional review board. All patients provided informed
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consent before any study-related procedures were performed. This prospective case series consecutively enrolled 20 patients with large incisional hernia at a single center. The main entry criteria were adults with large incisional hernia (width or length ≥ 10 cm) who required primary elective repair. Incisional hernia was defined as any abdominal wall gap with or without a bulge
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in the area of a postoperative scar perceptible or palpable by clinical examination or imaging 14. Exclusion criteria included pregnant females, signs of infection, strangulated or irreducible
2.2 Procedures
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hernia, and participation in other clinical trials.
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Patients who met all study entry criteria underwent preoperative history and physical. Patients were electively treated at a dedicated hernia center by a single surgeon (SH). The hernia sac was dissected. The sac was not opened in most cases if possible. This is the routine repair technique that is used at this center. The sac was reduced. The open primary repair was first performed with as little tension as possible using a double stranded 0-nylon continuous closure. ProGrip mesh is a large-pore knitted fabric of monofilament polyester that incorporates resorbable
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microgrips of polylactic acid on one side that facilitate placement and positioning by encouraging immediate tension-free fixation to surrounding tissue. The resorbable microgrips endow the mesh with self-gripping properties during the first several months after implantation
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and eliminate or reduce the need for fixation by suture, which may penetrate underlying tissue and damage cutaneous nerves. Mesh density is 75 g/m2 at implantation and 38 g/m2 after
absorption. The mesh was placed using onlay technique over the abdominal wall closure in the
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subcutaneous prefascial space extending 4-5 cm beyond the wound margins (Fig. 1). The grips were placed facing down towards the fascia. To standardize mesh fixation and facilitate mesh
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placement the mesh was minimally fixated in four quadrants with resorbable sutures although this step is not required. A Jackson Pratt subcutaneous drain was placed in 15 patients. After recovery, patients were discharged that day or admitted to the hospital for 24 hours observation.
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2.3 Outcomes
Patients returned for follow-up visits at 1, 3, 6, 12, and 24 months, which included patient interview and physical examination. Main outcomes included pain severity on a 0 (no pain) to
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10 (worst pain imaginable) scale, Carolinas Comfort Scale (CCS) to assess hernia-specific quality of life 15, patient satisfaction, adverse events, and hernia recurrence 16. Adverse events
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(AEs) were categorized by seriousness (serious, non-serious) and severity (mild, moderate, severe). A serious AE was defined as any event that was fatal, life-threatening, required prolonged hospitalization (> 48 hours), was a persistent or significant disability or incapacity, or was considered an important medical event. A mild AE was defined as awareness of signs or symptoms, but easily tolerated and of minor irritant type causing no loss of time from normal activities; symptoms did not require therapy or a medical evaluation; signs and symptoms were
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transient. A moderate AE was defined as an event that introduced a low level of inconvenience or concern to the participant and interfered with daily activities, but are usually improved by simple therapeutic measures; moderate experiences may cause some interference with
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functioning. A severe AE was an event that interrupted the participant’s normal daily activities, generally required systemic drug therapy or other treatment; and were usually incapacitating.
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2.4 Data analysis
Statistical analysis was performed by an independent biostatistician, who received all data for
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analysis directly from an electronic database. Continuous variables were reported as mean ± SD and categorical variables were presented as n (%). Longitudinal outcomes were analyzed with repeated measures ANOVA. Statistical significance was set at p<0.05. Statistical analyses were
3.0 Results
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performed using Predictive Analytics Software (version 22; IBM, Inc., Armonk, NY, USA).
A total of 20 patients (10 female, 10 male; mean age 62±12 yr; mean body mass index 35±9
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kg/m2) with large incisional hernia (mean defect size: 84±28 cm2) were treated at a dedicated hernia center between April 2012 and January 2013. Baseline patient characteristics are
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presented in Table 1. Median mesh fixation time was 2 minutes. Mean operative time was 38 minutes and blood loss was minimal (50 cc). Patients were discharged same day (n=15) or next day (n=5) (Table 2). The only postoperative complication was minor seroma in one patient, which was treated with fluid aspiration. By the 1-month follow-up, all patients had returned to normal daily activities and all 10 employed patients had returned to work.
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Patient follow-up compliance through 2 years was 100%. Mean pain score was 1.8±2.0 at discharge, 0.9±1.7 at 1 month, 0.7±1.7 at 1 year, and 0 at 2 years (Fig. 2). Residual mild/moderate pain was reported in 2 (10%) patients at the 6- and 12-month follow-up visits. By
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2 years, no patient reported residual pain of any severity. At 2-year follow-up, hernia-specific quality of life was excellent (mean CCS score=0) (Fig. 3). No mesh sensation or movement limitations were reported in any patient. All patients were satisfied or very satisfied with
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treatment at every follow-up visit through 2 years. Through 2 years follow-up, no surgical site infection, mesh removal, adverse event (regardless of seriousness or severity), or hernia
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recurrence were reported.
4.0 Discussion
This prospective study demonstrates that the ProGrip self-gripping mesh is a safe and effective
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treatment option to facilitate durable open repair of incisional hernia. Despite a challenging patient population characterized by obesity and large/giant incisional hernia, we report a mean mesh fixation time of 2 minutes, operative time of 38 minutes, minimal blood loss, same day
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discharge in most patients, with no major perioperative complications. Additionally, through 2 years, there were no major complications, recurrences, or reports of residual pain. These
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outcomes compare favorably to previous studies in similar patient populations. For example, Memon et al.17 treated 60 patients with large or giant incisional hernia using a mesh primarily with onlay technique. Perioperative complications were identified in 23% of patients, surgical site infection in 22%, with a 7% recurrence rate through a mean 20-month follow-up period. Differences in mesh type and/or surgical technique are the most plausible explanations for these discrepant outcomes.
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All patients in the current series were treated with mesh using onlay technique. Although sublay is generally considered the gold standard for open incisional hernia repair, the procedure can be
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technically difficult, has a steeper learning curve, and requires a longer operative time 18.
However, onlay repair is associated with higher rates of surgical site infection 18-20, seroma 18,19, and recurrence 20 versus sublay technique. Onlay technique however has severable
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advantages−it is an easier procedure, takes less time to accomplish, and is associated with fewer perioperative complications 21. A favorable repair using onlay Progrip requires the primary
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suture repair to be performed with as little tension as possible and, if needed, component separation should be done. We prefer good overlap of the mesh of about 4 cm – 5 cm from each side of the primary repair suture line.
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Data from the Swedish Hernia Registry report that 31% of patients report some degree of pain 23 years following surgery, with 6% reporting pain that interferes with daily activities 22. At 2 years follow-up in the current series, all patients were completely free from pain and hernia-
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specific quality of life was excellent. The causes of persistent postoperative pain are likely multifactorial and may include iatrogenic nerve injury or entrapment, inflammatory reaction to
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mesh, or issues related to mesh tension due to additional suture or tack fixation. Our experience with the ProGrip mesh suggests that use of a self-gripping mesh using onlay technique offers a durable, tension-free repair without the need for additional permanent fixation that may cause persistent pain.
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In this study we elected to minimally fixate the mesh in the onlay position with an absorbable suture for consistency and facilitate placement. It should be noted that this study was conducted early in our experience placing the mesh. We feel this minimal fixation does not contribute to
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the long term fixation properties of the technique since a short term absorbable suture was used to assist in placement of the mesh. This is consistent with what has been described in the open inguinal hernia procedure using the mesh. Additional fixation was at the surgeons discretion.
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We report to not routinely use any additional fixation on similar repairs currently.
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This onlay procedure using self gripping mesh appears to differ from previously reported open onlay repairs. The self gripping properties of this mesh allows an almost complete or near complete adhesion and fixation of the mesh which encompasses nearly all of the surface area of the repair. This is similar to using a fibrin glue and/or tacks. One of the main issues with any
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ventral hernia mesh repair is that immediate fixation of the entire surface area of the mesh is not accomplished by tacks, sutures or glue. The majority of the mesh is not secured and there are gaps at the multiple fixation points. This is thought to be a source for recurrence and failure of
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the repair. The self gripping nature of this mesh seems to allow better fixation qualities then the above fixation methods. Essentially, the mesh is almost immediately fixated along the entire
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surface area of the primary and mesh repair. In addition, this fixation property appears to reduce tension on the repair which is major contributor to failure and recurrence.
The main limitation of this study was a small sample size, which may have been insufficient to detect rare events. However, this study is novel in that few mesh studies have followed patients with large incisional hernia for at least 2 years. In order to further elucidate the benefit of self-
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gripping mesh, we recommend that future studies consider a larger sample size with longer follow-up. Additionally, comparative studies of onlay versus sublay position, open versus laparoscopic repair, and permanent fixation versus no fixation are warranted to identify the ideal
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treatment strategy.
Overall, open repair using a self-gripping mesh is a viable treatment option in patients with large
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incisional hernia. This study shows immediate mesh fixation using this technology facilitates a
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safe and durable repair.
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Conflict of interest statement
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None.
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Role of the funding source
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This study was supported by Covidien (Mansfield, MA).
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References
Mudge M, Hughes LE. Incisional hernia: a 10 year prospective study of incidence and attitudes. The British journal of surgery. 1985;72(1):70-71.
2.
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1.
Rodriguez HE, Matsumura JS, Morasch MD, Greenberg RK, Pearce WH. Abdominal wall hernias after open abdominal aortic aneurysm repair: prospective radiographic
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detection and clinical implications. Vascular and endovascular surgery. 2004;38(3):237240.
Luijendijk RW, Hop WC, van den Tol MP, et al. A comparison of suture repair with
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mesh repair for incisional hernia. The New England journal of medicine. 2000;343(6):392-398. 4.
Adotey JM. Incisional hernia: a review. Nigerian journal of medicine : journal of the
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National Association of Resident Doctors of Nigeria. 2006;15(1):34-43. Vidovic D, Jurisic D, Franjic BD, Glavan E, Ledinsky M, Bekavac-Beslin M. Factors affecting recurrence after incisional hernia repair. Hernia : the journal of hernias and
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abdominal wall surgery. 2006;10(4):322-325. Burger JW, Luijendijk RW, Hop WC, Halm JA, Verdaasdonk EG, Jeekel J. Long-term
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follow-up of a randomized controlled trial of suture versus mesh repair of incisional hernia. Annals of surgery. 2004;240(4):578-583; discussion 583-575.
7.
Muller-Riemenschneider F, Roll S, Friedrich M, et al. Medical effectiveness and safety of
conventional compared to laparoscopic incisional hernia repair: a systematic review. Surgical endoscopy. 2007;21(12):2127-2136.
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Eriksen JR, Gogenur I, Rosenberg J. Choice of mesh for laparoscopic ventral hernia repair. Hernia : the journal of hernias and abdominal wall surgery. 2007;11(6):481-492.
9.
Korenkov M, Sauerland S, Arndt M, Bograd L, Neugebauer EA, Troidl H. Randomized
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clinical trial of suture repair, polypropylene mesh or autodermal hernioplasty for incisional hernia. The British journal of surgery. 2002;89(1):50-56.
Chastan P. Tension-free open hernia repair using an innovative self-gripping semiresorbable mesh. Hernia. 2009;13(2):137-142.
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Kapischke M, Schulze H, Caliebe A. Self-fixating mesh for the Lichtenstein procedure—
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a prestudy. Langenbeck's Archives of Surgery. 2010;395(4):317-322.
Hopson S. Parietex ProGrip mesh in open ventral hernia repair. EHS meeting. 2010;ID157(Presentation Code: OP-55) (CONCURRENT SESSION-7 (8.10.2010 / ROOM C / 09.00-10.30)).
Hesselink VJ, Luijendijk RW, de Wilt JH, Heide R, Jeekel J. An evaluation of risk
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13.
factors in incisional hernia recurrence. Surgery, gynecology & obstetrics. 1993;176(3):228-234.
Korenkov M, Paul A, Sauerland S, et al. Classification and surgical treatment of
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incisional hernia. Results of an experts' meeting. Langenbeck's archives of surgery /
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Deutsche Gesellschaft fur Chirurgie. 2001;386(1):65-73.
Heniford BT, Walters AL, Lincourt AE, Novitsky YW, Hope WW, Kercher KW. Comparison of generic versus specific quality-of-life scales for mesh hernia repairs. Journal of the American College of Surgeons. 2008;206(4):638-644.
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Muysoms F, Miserez M, Berrevoet F, et al. Classification of primary and incisional abdominal wall hernias. Hernia. 2009;13(4):407-414.
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17.
Memon AA, Khan A, Zafar H, Murtaza G, Zaidi M. Repair of large and giant incisional hernia with onlay mesh: perspective of a tertiary care hospital of a developing country. International journal of surgery. 2013;11(1):41-45. Carlson MA, Ludwig KA, Condon RE. Ventral hernia and other complications of 1,000
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18.
midline incisions. Southern medical journal. 1995;88(4):450-453. 19.
Ceydeli A, Rucinski J, Wise L. Finding the best abdominal closure: an evidence-based
20.
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review of the literature. Current surgery. 2005;62(2):220-225.
Timmermans L, de Goede B, van Dijk SM, Kleinrensink GJ, Jeekel J, Lange JF. Meta-
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analysis of sublay versus onlay mesh repair in incisional hernia surgery. American journal of surgery. 2014;207(6):980-988. 21.
Eker HH, Hansson BM, Buunen M, et al. Laparoscopic vs. open incisional hernia repair: a randomized clinical trial. JAMA Surg. 2013;148(3):259-263.
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Franneby U, Sandblom G, Nordin P, Nyren O, Gunnarsson U. Risk factors for long-term
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pain after hernia surgery. Annals of surgery. 2006;244(2):212-219.
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22.
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Table 1. Baseline patient characteristics Value Variable (n=20) Demographics Female gender, n (%) 10 (50) Age, yr 62±12 (36-79) Body mass index, kg/m2 35±9 (20-55) Defect size, cm2 84±28 (50-144) -Large (≥10 cm) 18 (90) -Giant (≥15 cm) 2 (10) ASA class III, n (%) 8 (40) Symptoms Pain severity 3.2±2.2 (0-7) Carolinas Comfort Scale 10±13 (0-51) Medical history1 Obesity 13 (65) Hypertension 7 (35) Smoking history 3 (15) Diabetes 2 (10) Cardiac disease 2 (10) 1 Surgical history Cholecystectomy 8 (40) Hysterectomy 6 (30) Colectomy 5 (25) Abdominal aortic aneurysm repair 3 (15) Appendectomy 3 (15) Hernia repair 3 (15) Bladder surgery 2 (10) Laparotomy 2 (10) 1 Variables reported with frequency ≥ 10%
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Tables
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Table 2. Procedural data
General anesthesia Mesh size -20x15 cm -30x15 cm Mesh fixation time, min Operative time, min Blood loss, cc Hospital stay -same day -next day
17 3 2 (1-5) 38 (21-66) 50 (50 all)
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15 (75) 5 (25)
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Value (n=20) 20 (100)
Variable
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Figure Legends
Figure 2. Pain severity through 2 years
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Figure 3. Carolinas Comfort Scale through 2 years
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Figure 1. Progrip onlay mesh repair.
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Highlights •
20 patients with large primary incisional hernia (mean defect size: 84 cm2) were treated with a macroporous polyester mesh with resorbable polylactic acid microgrips using open
•
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onlay technique.
Through 2 years follow-up, no infection, mesh removal, or hernia recurrence were reported.
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At 2 years, all patients reported no pain, excellent hernia-specific quality of life, and were
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“very satisfied” with treatment.
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•
1
S1743-9191(15)01258-3
DOI:
10.1016/j.ijsu.2015.09.069
Reference:
IJSU 2262
To appear in:
International Journal of Surgery
Received Date: 8 July 2015 Revised Date:
16 September 2015
Accepted Date: 26 September 2015
Please cite this article as: Hopson SB, Miller LE, Open ventral hernia repair using progrip™ self-gripping mesh, International Journal of Surgery (2015), doi: 10.1016/j.ijsu.2015.09.069. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
ACCEPTED MANUSCRIPT
OPEN VENTRAL HERNIA REPAIR USING PROGRIP™ SELF-GRIPPING MESH Steven B. Hopson, MD, FACSa, Larry E. Miller, PhDb
Bon Secours TPMG Hernia Center, 860 Omni Boulevard, Suite 204, Newport News, VA,
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a
23606, USA; [email protected] b
Miller Scientific Consulting, Inc., 1854 Hendersonville Road, #231, Asheville, NC, 28803,
Steven B. Hopson, MD, FACS Bon Secours TPMG Hernia Center 860 Omni Boulevard, Suite 204
Phone: +01 (757) 846 4335
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Newport News, VA 23606, USA
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Corresponding author
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USA; [email protected]
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Email: [email protected]
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Running title: Self-gripping mesh for open ventral hernia repair
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Abstract
Purpose: Secure mesh fixation in incisional hernia repair is mandatory to prevent mesh
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dislocation and possible recurrence. Traditional fixation methods have been implicated as a source of chronic postoperative pain. We report 2-year outcomes with a self-gripping mesh for open tension-free repair of large incisional hernia.
SC
Methods: This prospective case series enrolled 20 patients with large primary incisional hernia (mean defect size: 84 cm2). Patients were electively treated by a single surgeon using a
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macroporous polyester mesh with resorbable polylactic acid microgrips (ProGrip™, Covidien, Mansfield, MA, USA) using open onlay technique. Main outcomes included pain severity, Carolinas Comfort Scale (CCS), complications, and hernia recurrence. Patients returned for follow-up at 1, 3, 6, 12, and 24 months.
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Results: Median mesh fixation time was 2 minutes. Mean operative time was 38 minutes and blood loss was minimal (50 cc). Most patients (75%) were discharged same day. The only perioperative complication was a minor seroma in one patient. Patient follow-up compliance
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through 2 years was 100%. Mean pain score was 1.8 at discharge, 0.9 at 1 month, 0.7 at 1 year, and 0 at 2 years. At 2-years, all patients were “very satisfied” with treatment and hernia-specific
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quality of life was excellent (mean CCS score=0). No infection, mesh removal, or hernia recurrence occurred during follow-up. Conclusions: Open repair using a self-gripping mesh is a viable treatment option in patients with large incisional hernia. Immediate mesh fixation facilitates a safe and durable tension-free repair.
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Keywords: incisional hernia, mesh, ProGrip, recurrence
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1.0 Introduction Incisional hernia is a common complication of abdominal surgery that contributes to chronic pain, decreased quality of life, and significant healthcare costs 1,2. In some cases, incisional
RI PT
hernia results in serious complications such as incarceration or strangulation that require prompt reduction in order to prevent bowel ischemia. Although numerous direct suture repair techniques have been described in the literature, recurrence remains common with rates ranging from 39%
SC
to 49% 3-5. Mesh repair lowers the long-term risk of recurrence by approximately 50% compared to suture repair 6. Consequently, the use of mesh to reinforce incisional hernia repair has become
M AN U
standard of care at most centers although the preferred operative method 7, mesh type 8, and mesh positioning 9 remain controversial topics. The etiology of recurrence and chronic postoperative pain is multifactorial and may be related to mesh placement technique, mesh type, or mesh fixation method. Continued refinements in surgical technique and mesh technology are
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mandatory to identify the ideal treatment algorithm in incisional hernia repair.
A novel self-gripping mesh (ProGrip™, Covidien, Mansfield, MA, USA) has been developed to
EP
achieve secure, long-term abdominal wall reinforcement without the need for additional permanent fixation. Promising clinical outcomes have been reported with this mesh in inguinal
AC C
hernia repair 10,11. However, its use in incisional hernia repair is more limited. A case series of 21 patients with incisional hernia (4-6 cm) treated with open repair using ProGrip mesh reported excellent outcomes through 6 months follow-up 12. However, no published series have investigated the use of this mesh in patients with larger incisional hernia, a major risk factor for recurrence 13. Additionally, no known reports have described long-term outcomes with onlay repair of large incisional hernias. Therefore, the purpose of this study was to report 2-year
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outcomes in patients treated with a self-gripping mesh for tension-free onlay open repair of large incisional hernias.
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2.0 Methods
2.1 Patients
SC
All research performed in this study was in strict accordance with a common, pre-defined
protocol that was approved by a local institutional review board. All patients provided informed
M AN U
consent before any study-related procedures were performed. This prospective case series consecutively enrolled 20 patients with large incisional hernia at a single center. The main entry criteria were adults with large incisional hernia (width or length ≥ 10 cm) who required primary elective repair. Incisional hernia was defined as any abdominal wall gap with or without a bulge
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in the area of a postoperative scar perceptible or palpable by clinical examination or imaging 14. Exclusion criteria included pregnant females, signs of infection, strangulated or irreducible
2.2 Procedures
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hernia, and participation in other clinical trials.
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Patients who met all study entry criteria underwent preoperative history and physical. Patients were electively treated at a dedicated hernia center by a single surgeon (SH). The hernia sac was dissected. The sac was not opened in most cases if possible. This is the routine repair technique that is used at this center. The sac was reduced. The open primary repair was first performed with as little tension as possible using a double stranded 0-nylon continuous closure. ProGrip mesh is a large-pore knitted fabric of monofilament polyester that incorporates resorbable
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microgrips of polylactic acid on one side that facilitate placement and positioning by encouraging immediate tension-free fixation to surrounding tissue. The resorbable microgrips endow the mesh with self-gripping properties during the first several months after implantation
RI PT
and eliminate or reduce the need for fixation by suture, which may penetrate underlying tissue and damage cutaneous nerves. Mesh density is 75 g/m2 at implantation and 38 g/m2 after
absorption. The mesh was placed using onlay technique over the abdominal wall closure in the
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subcutaneous prefascial space extending 4-5 cm beyond the wound margins (Fig. 1). The grips were placed facing down towards the fascia. To standardize mesh fixation and facilitate mesh
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placement the mesh was minimally fixated in four quadrants with resorbable sutures although this step is not required. A Jackson Pratt subcutaneous drain was placed in 15 patients. After recovery, patients were discharged that day or admitted to the hospital for 24 hours observation.
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2.3 Outcomes
Patients returned for follow-up visits at 1, 3, 6, 12, and 24 months, which included patient interview and physical examination. Main outcomes included pain severity on a 0 (no pain) to
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10 (worst pain imaginable) scale, Carolinas Comfort Scale (CCS) to assess hernia-specific quality of life 15, patient satisfaction, adverse events, and hernia recurrence 16. Adverse events
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(AEs) were categorized by seriousness (serious, non-serious) and severity (mild, moderate, severe). A serious AE was defined as any event that was fatal, life-threatening, required prolonged hospitalization (> 48 hours), was a persistent or significant disability or incapacity, or was considered an important medical event. A mild AE was defined as awareness of signs or symptoms, but easily tolerated and of minor irritant type causing no loss of time from normal activities; symptoms did not require therapy or a medical evaluation; signs and symptoms were
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transient. A moderate AE was defined as an event that introduced a low level of inconvenience or concern to the participant and interfered with daily activities, but are usually improved by simple therapeutic measures; moderate experiences may cause some interference with
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functioning. A severe AE was an event that interrupted the participant’s normal daily activities, generally required systemic drug therapy or other treatment; and were usually incapacitating.
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2.4 Data analysis
Statistical analysis was performed by an independent biostatistician, who received all data for
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analysis directly from an electronic database. Continuous variables were reported as mean ± SD and categorical variables were presented as n (%). Longitudinal outcomes were analyzed with repeated measures ANOVA. Statistical significance was set at p<0.05. Statistical analyses were
3.0 Results
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performed using Predictive Analytics Software (version 22; IBM, Inc., Armonk, NY, USA).
A total of 20 patients (10 female, 10 male; mean age 62±12 yr; mean body mass index 35±9
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kg/m2) with large incisional hernia (mean defect size: 84±28 cm2) were treated at a dedicated hernia center between April 2012 and January 2013. Baseline patient characteristics are
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presented in Table 1. Median mesh fixation time was 2 minutes. Mean operative time was 38 minutes and blood loss was minimal (50 cc). Patients were discharged same day (n=15) or next day (n=5) (Table 2). The only postoperative complication was minor seroma in one patient, which was treated with fluid aspiration. By the 1-month follow-up, all patients had returned to normal daily activities and all 10 employed patients had returned to work.
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Patient follow-up compliance through 2 years was 100%. Mean pain score was 1.8±2.0 at discharge, 0.9±1.7 at 1 month, 0.7±1.7 at 1 year, and 0 at 2 years (Fig. 2). Residual mild/moderate pain was reported in 2 (10%) patients at the 6- and 12-month follow-up visits. By
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2 years, no patient reported residual pain of any severity. At 2-year follow-up, hernia-specific quality of life was excellent (mean CCS score=0) (Fig. 3). No mesh sensation or movement limitations were reported in any patient. All patients were satisfied or very satisfied with
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treatment at every follow-up visit through 2 years. Through 2 years follow-up, no surgical site infection, mesh removal, adverse event (regardless of seriousness or severity), or hernia
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recurrence were reported.
4.0 Discussion
This prospective study demonstrates that the ProGrip self-gripping mesh is a safe and effective
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treatment option to facilitate durable open repair of incisional hernia. Despite a challenging patient population characterized by obesity and large/giant incisional hernia, we report a mean mesh fixation time of 2 minutes, operative time of 38 minutes, minimal blood loss, same day
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discharge in most patients, with no major perioperative complications. Additionally, through 2 years, there were no major complications, recurrences, or reports of residual pain. These
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outcomes compare favorably to previous studies in similar patient populations. For example, Memon et al.17 treated 60 patients with large or giant incisional hernia using a mesh primarily with onlay technique. Perioperative complications were identified in 23% of patients, surgical site infection in 22%, with a 7% recurrence rate through a mean 20-month follow-up period. Differences in mesh type and/or surgical technique are the most plausible explanations for these discrepant outcomes.
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All patients in the current series were treated with mesh using onlay technique. Although sublay is generally considered the gold standard for open incisional hernia repair, the procedure can be
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technically difficult, has a steeper learning curve, and requires a longer operative time 18.
However, onlay repair is associated with higher rates of surgical site infection 18-20, seroma 18,19, and recurrence 20 versus sublay technique. Onlay technique however has severable
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advantages−it is an easier procedure, takes less time to accomplish, and is associated with fewer perioperative complications 21. A favorable repair using onlay Progrip requires the primary
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suture repair to be performed with as little tension as possible and, if needed, component separation should be done. We prefer good overlap of the mesh of about 4 cm – 5 cm from each side of the primary repair suture line.
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Data from the Swedish Hernia Registry report that 31% of patients report some degree of pain 23 years following surgery, with 6% reporting pain that interferes with daily activities 22. At 2 years follow-up in the current series, all patients were completely free from pain and hernia-
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specific quality of life was excellent. The causes of persistent postoperative pain are likely multifactorial and may include iatrogenic nerve injury or entrapment, inflammatory reaction to
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mesh, or issues related to mesh tension due to additional suture or tack fixation. Our experience with the ProGrip mesh suggests that use of a self-gripping mesh using onlay technique offers a durable, tension-free repair without the need for additional permanent fixation that may cause persistent pain.
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In this study we elected to minimally fixate the mesh in the onlay position with an absorbable suture for consistency and facilitate placement. It should be noted that this study was conducted early in our experience placing the mesh. We feel this minimal fixation does not contribute to
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the long term fixation properties of the technique since a short term absorbable suture was used to assist in placement of the mesh. This is consistent with what has been described in the open inguinal hernia procedure using the mesh. Additional fixation was at the surgeons discretion.
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We report to not routinely use any additional fixation on similar repairs currently.
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This onlay procedure using self gripping mesh appears to differ from previously reported open onlay repairs. The self gripping properties of this mesh allows an almost complete or near complete adhesion and fixation of the mesh which encompasses nearly all of the surface area of the repair. This is similar to using a fibrin glue and/or tacks. One of the main issues with any
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ventral hernia mesh repair is that immediate fixation of the entire surface area of the mesh is not accomplished by tacks, sutures or glue. The majority of the mesh is not secured and there are gaps at the multiple fixation points. This is thought to be a source for recurrence and failure of
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the repair. The self gripping nature of this mesh seems to allow better fixation qualities then the above fixation methods. Essentially, the mesh is almost immediately fixated along the entire
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surface area of the primary and mesh repair. In addition, this fixation property appears to reduce tension on the repair which is major contributor to failure and recurrence.
The main limitation of this study was a small sample size, which may have been insufficient to detect rare events. However, this study is novel in that few mesh studies have followed patients with large incisional hernia for at least 2 years. In order to further elucidate the benefit of self-
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gripping mesh, we recommend that future studies consider a larger sample size with longer follow-up. Additionally, comparative studies of onlay versus sublay position, open versus laparoscopic repair, and permanent fixation versus no fixation are warranted to identify the ideal
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treatment strategy.
Overall, open repair using a self-gripping mesh is a viable treatment option in patients with large
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incisional hernia. This study shows immediate mesh fixation using this technology facilitates a
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safe and durable repair.
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Conflict of interest statement
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None.
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Role of the funding source
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This study was supported by Covidien (Mansfield, MA).
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References
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National Association of Resident Doctors of Nigeria. 2006;15(1):34-43. Vidovic D, Jurisic D, Franjic BD, Glavan E, Ledinsky M, Bekavac-Beslin M. Factors affecting recurrence after incisional hernia repair. Hernia : the journal of hernias and
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Korenkov M, Sauerland S, Arndt M, Bograd L, Neugebauer EA, Troidl H. Randomized
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clinical trial of suture repair, polypropylene mesh or autodermal hernioplasty for incisional hernia. The British journal of surgery. 2002;89(1):50-56.
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a prestudy. Langenbeck's Archives of Surgery. 2010;395(4):317-322.
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Hesselink VJ, Luijendijk RW, de Wilt JH, Heide R, Jeekel J. An evaluation of risk
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Korenkov M, Paul A, Sauerland S, et al. Classification and surgical treatment of
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incisional hernia. Results of an experts' meeting. Langenbeck's archives of surgery /
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Deutsche Gesellschaft fur Chirurgie. 2001;386(1):65-73.
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Muysoms F, Miserez M, Berrevoet F, et al. Classification of primary and incisional abdominal wall hernias. Hernia. 2009;13(4):407-414.
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17.
Memon AA, Khan A, Zafar H, Murtaza G, Zaidi M. Repair of large and giant incisional hernia with onlay mesh: perspective of a tertiary care hospital of a developing country. International journal of surgery. 2013;11(1):41-45. Carlson MA, Ludwig KA, Condon RE. Ventral hernia and other complications of 1,000
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analysis of sublay versus onlay mesh repair in incisional hernia surgery. American journal of surgery. 2014;207(6):980-988. 21.
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Table 1. Baseline patient characteristics Value Variable (n=20) Demographics Female gender, n (%) 10 (50) Age, yr 62±12 (36-79) Body mass index, kg/m2 35±9 (20-55) Defect size, cm2 84±28 (50-144) -Large (≥10 cm) 18 (90) -Giant (≥15 cm) 2 (10) ASA class III, n (%) 8 (40) Symptoms Pain severity 3.2±2.2 (0-7) Carolinas Comfort Scale 10±13 (0-51) Medical history1 Obesity 13 (65) Hypertension 7 (35) Smoking history 3 (15) Diabetes 2 (10) Cardiac disease 2 (10) 1 Surgical history Cholecystectomy 8 (40) Hysterectomy 6 (30) Colectomy 5 (25) Abdominal aortic aneurysm repair 3 (15) Appendectomy 3 (15) Hernia repair 3 (15) Bladder surgery 2 (10) Laparotomy 2 (10) 1 Variables reported with frequency ≥ 10%
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Tables
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Table 2. Procedural data
General anesthesia Mesh size -20x15 cm -30x15 cm Mesh fixation time, min Operative time, min Blood loss, cc Hospital stay -same day -next day
17 3 2 (1-5) 38 (21-66) 50 (50 all)
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15 (75) 5 (25)
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Value (n=20) 20 (100)
Variable
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Figure Legends
Figure 2. Pain severity through 2 years
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Figure 3. Carolinas Comfort Scale through 2 years
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Figure 1. Progrip onlay mesh repair.
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Highlights •
20 patients with large primary incisional hernia (mean defect size: 84 cm2) were treated with a macroporous polyester mesh with resorbable polylactic acid microgrips using open
•
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onlay technique.
Through 2 years follow-up, no infection, mesh removal, or hernia recurrence were reported.
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At 2 years, all patients reported no pain, excellent hernia-specific quality of life, and were
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“very satisfied” with treatment.
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•
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