International Journal of Surgery 17 (2015) 79e82

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Original research

A prospective randomised trial comparing mesh types and fixation in totally extraperitoneal inguinal hernia repairs Adam Cristaudo a, *, Arun Nayak b, Sarah Martin c, Reza Adib d, Ian Martin b a

Princess Alexandra Hospital, Woolloongabba, QLD 4102, Australia Department of Upper GI Surgery, Princess Alexandra Hospital, Woolloongabba, Queensland, Australia c The Wesley Research Institute, Auchenflower, Queensland, Australia d The Wesley Hospital, Auchenflower, Queensland, Australia b

h i g h l i g h t s  Totally extraperitoneal inguinal hernia repairs are now a popular technique.  A prospective RCT compared comfort scores using different mesh types and fixation.  At 1, 2, 4 & 12 weeks, median global CCS scores were low for all treatment groups.  No statistical differences in CCS scores amongst mesh type or fixation method used.

a r t i c l e i n f o

a b s t r a c t

Article history: Received 11 March 2015 Accepted 16 March 2015 Available online 4 April 2015

The totally extraperitoneal (TEP) approach for surgical repair of inguinal hernias has emerged as a popular technique. We conducted a prospective randomised trial to compare patient comfort scores using different mesh types and fixation using this technique. Over a 14 month period, 146 patients underwent 232 TEP inguinal hernia repairs. We compared the comfort scores of patients who underwent these procedures using different types of mesh and fixation. A non-absorbable 15  10 cm anatomical mesh fixed with absorbable tacks (Control group) was compared with either a non-absorbable 15  10 cm folding slit mesh with absorbable tacks (Group 2), a partiallyabsorbable 15  10 cm mesh with absorbable tacks (Group 3) or a non-absorbable 15  10 cm anatomical mesh fixed with 2 ml fibrin sealant (Group 4). Outcomes were compared at 1, 2, 4 and 12 weeks using the Carolina Comfort Scale (CCS) scores. At 1, 2, 4 and 12 weeks, the median global CCS scores were low for all treatment groups. Statistically significant differences were seen only for median CCS scores and subscores with the use of partiallyabsorbable mesh with absorbable tacks (Group 3) at weeks 2 and 4. However, these were no longer significant at week 12. In this study, the TEP inguinal hernia repair with minimal fixation results in low CCS scores. There were no statistical differences in CCS scores when comparing types of mesh, configuration of the mesh or fixation methods. © 2015 IJS Publishing Group Limited. Published by Elsevier Ltd. All rights reserved.

Keywords: Hernia Inguinal Totally extraperitoneal Mesh Fibrin sealant

1. Introduction Studies involving the totally extraperitoneal (TEP) approach for surgical repair of inguinal hernias have illustrated advantages, such as quicker recovery, earlier return to work and reduced postoperative pain [1]. The TEP approach has the potential to repair

* Corresponding author. E-mail address: [email protected] (A. Cristaudo).

bilateral inguinal hernias using the same three access ports, the ability to diagnose and repair associated femoral and obturator hernias, and is excellent for recurrent hernia management following previous open repair [2]. Evolution from sutured to mesh repair has reduced the incidence of hernia recurrence, however groin pain continues to be an issue for some patients, and mesh type and fixation methods are often implicated [3]. In this study, we trialled three different light-weight mesh types using two different fixation methods in relation to post-operative

http://dx.doi.org/10.1016/j.ijsu.2015.03.018 1743-9191/© 2015 IJS Publishing Group Limited. Published by Elsevier Ltd. All rights reserved.

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A. Cristaudo et al. / International Journal of Surgery 17 (2015) 79e82

groin pain measured by Carolina Comfort Scale (CCS) scores [4].

Table 1 Patient characteristics by treatment combination.

2. Methods From 2005, over an accrual period of 14 months, patients were prospectively randomised between using the non-absorbable anatomical mesh with absorbable tacks (Control group; Parietex, 15  10 cm) with either non-absorbable folding slit mesh with absorbable tacks (Group 2; Parietex, 15  10 cm), partiallyabsorbable mesh with absorbable tacks (Group 3; Ultrapro, 15  10 cm) or non-absorbable anatomical mesh fixed with 2 ml fibrin sealant (Group 4; Parietex, 15  10 cm; Tisseel fibrin glue). Patient's demographic and medical history was recorded. They were consented for the trial, which had ethics committee approval. Immediately preoperatively an opaque envelope was opened which dictated the type of mesh and fixation technique randomised for each hernia side (random allocation numbers were utilised for allocation). Each surgeon had performed over 1000 TEP procedures previously. All were performed under general anaesthetic. A subrectus space was created using a small incision just below the umbilicus. The subrectus space was inflated under vision using a dissection balloon to create the extraperitoneal space. Two 5 mm ports were sited under vision in a vertical line below the umbilicus and at least 5 cm above the symphysis pubis. Following reduction of all hernias, the mesh was fixed medially to the lacunar ligament (two sites), medial and superior (two sites), and lateral and superior (one site) using absorbable tacks (Control group, Group 2, and Group 3) or using 2 ml of fibrin sealant (Group 4) in similar areas. Up to 20 ml of 0.25% bupivacaine was injected to the three skin incisions at the end of the procedure. All patients were discharged home within 24 h of their admission on oral paracetamol and ibuprofen for use at their discretion. Patients were asked to refrain from heavy lifting for 2 weeks as the only limitation to activities. All patients underwent clinical examination between four to eight weeks postoperatively and were contacted per phone by an independent scientific researcher at 1, 2, 4 and 12 weeks to complete the CCS questionnaire, hence a 100% response rate. For bilateral repairs, patients were interviewed to complete two CCS scores, one for each side. The CCS questionnaire was used to collect responses to a total of 23 questions relating to eight domains. Totals were calculated for each of the eight domains and a global CCS score was calculated as the sum of all 23 values. Analgesic consumption post-operatively was not quantified. Statistical analysis was performed using the R Development Core Team [5]. The global CCS scores and subscores for each review week were summarised as median. The control group (nonabsorbable anatomical mesh with absorbable tacks) was then compared to each of the other treatment groups using the ManneWhitney U test. Statistical significance was defined at the conventional level of 0.05.

Single hernia Control group Group 2 Group 3 Group 4 Bilateral hernia 2  Control group 2  Group 2 2  Group 3 2  Group 4 1  Control group, 1  Group 2 1  Control group, 1  Group 3 1  Control group, 1  Group 4

# Patients

# Females

60 13 14 16 17 86 15 5 23 28 3 4 8

2 0 2 0 0 3 0 0 0 3 0 0 0

Mean age (SD) 49.2 55.8 52.2 51.2

(16.8) (15.8) (17.1) (15.6)

48.5 59.0 56.6 56.2 35.7 40.0 49.8

(18.2) (10.0) (15.1) (15.0) (6.4) (4.5) (7.5)

However, there were no statistically significant differences in regards to global CCS scores or subscores in any of the treatment groups by week 12 post-operatively (Table 2). Over the course of the study, fortunately no significant intraoperative complications were encountered, and there was no conversion to open surgery. Two patients required a course of oral antibiotics for minor superficial infections at the umbilical port site. One hernia recurred two weeks postoperatively following placement of a non-absorbable anatomical mesh using fibrin sealant (Group 4) for a 5 cm direct inguinal hernia. This was subsequently repaired using an open approach with on-lay mesh reinforcement. Clinical follow-up was performed between four to eight weeks post-operatively without further adverse findings. 4. Discussion The first TEP inguinal hernia repair was described by Dulucq JL in 1992 [6]. Whilst relatively safe, higher recurrence and complications rates seen in earlier studies may have been due to evolvement of technique and the inherent learning curve of a new procedure [7,10,13,19]. Prospective studies and meta-analyses have suggested significant reduction in chronic pain and numbness [3,11,17e19], improvement in quality of life [9], reduced wound infection, seroma and hematoma rates when compared to the open procedure [8,12,16,17,19]. Despite this, post-operative groin pain remains a significant issue which is often attributed to the type of mesh used or fixation technique employed [3]. Evidence suggests that the ideal mesh for use in inguinal hernia repair should be monofilamentous, non-absorbable, light weight (1 mm pore size), stable (16 N/cm) and elastic (>20%) [20]. Although there are approximately 130 mesh types available, marketing ploys related to the above physical properties lack any comparative scientific substance in randomised human clinical trials. Light weight macroporous non-absorbable and partially-absorbable meshes were used in our study, in line with the European Hernia Society guidelines [14]. Whilst associated with less pain and foreign body sensation, several meta-analyses

3. Results One-hundred and forty-six patients underwent 232 TEP inguinal hernia procedures. Using five absorbable tacks only for fixation, 58 inguinal hernias were repaired with non-absorbable anatomical mesh (Control group), 27 with non-absorbable folding slit mesh (Group 2), and 66 with partially-absorbable mesh (Group 3). A further 81 hernial defects were repaired with non-absorbable anatomical mesh and fibrin sealant (Group 4) (Table 1). Significantly lower global CCS scores and subscores were seen at weeks 2 and 4 with the use of partially-absorbable mesh (Group 3).

Table 2 Summary statistics for the Carolina Comfort Scale scores. Review week

Control group Group 2 Group 3 Group 4

1

2

4

12

24.6 27.2 26.4 30.4

14.7 14.4 11.3 13.4

8.2 3.9* 3.7* 7.4

5.1 3.2 3.9 2.3

* denotes statistical significance (p < 0.05).

A. Cristaudo et al. / International Journal of Surgery 17 (2015) 79e82

fail to provide a clear advantage to the light weight mesh [21e24]. In our study, low CCS scores were found in all three mesh types with no significant differences identified. Recent meta analyses recommend fixation of mesh routinely, especially in large hernias (>3 cm) [25,26]. However, there have been concerns that the use of tacks may be associated with an increasing incidence of pain [28, 29]. Hence, alternatives to tacks have been sought. Fibrin sealant is a biodegradable adhesive formed by combination of human derived fibrinogen and thrombin activated by calcium chloride. It contains aprotinin, which has antifibrinolytic activity, prolonging the life span of the sealant [15e17]. A systematic review and meta-analysis in 2012 compared the use of staple fixation of mesh versus fibrin sealant fixation in laparoscopic TEP inguinal hernia repair and found there was no advantage in using one technique over the other. However, fibrin sealant mesh fixation decreased the incidence of chronic inguinal pain [27]. In our study, a randomised comparison of fibrin sealant and absorbable tacks did not find any statistical difference in relation to patient's CCS scores. This cohort of patients had a large number of bilateral repairs and a smaller number of female repairs reflecting the inherent referral bias of men with bilateral hernias to the two surgeons in this trial with known laparoscopic interests. Furthermore, we recognise the small size of this cohort and therefore the limited power to reflect statistical differences, particularly, because median global CCS scores were consistently very low at weeks 2, 4 and 12 for all groups. Statistical differences were also unlikely, considering the number of procedures in this study. There were no trends found to stimulate enthusiasm for a further larger study looking for statistical difference. A prospective randomised trial such as this comparing mesh types in humans is yet to be reported. Another weakness with our study was that analgesic requirements were not quantified post-operatively. We did however expect that pain with or without analgesics would be exposed with the extensive CCS questionnaire [4]. In conclusion, we found the TEP procedure, regardless of mesh type or fixation method to be associated with low CCS scores for up to 12 weeks post-operatively. Comments to editors The authors delayed the writing of this paper due to the negative results and initial lack of enthusiasm to publish. However, we feel the results may add usefully to the literature. Ethical approval The work involved in this manuscript has been approved by the Human Research Ethics Committee for the above institutions in which it was performed. Subjects gave informed consent to the work. UnitingCare Health Human Research Ethics Committee HREC Regiser No. 0849. Sources of funding Baxter Pharmaceutical gave a small grant to pay for a small part of the research time required. Author contribution Study design: Ian Martin, Reza Adib. Data collections & analysis: Ian Martin, Reza Adib, Sarah Martin. Writing: Adam Cristaudo, Arun Nayak, Ian Martin.

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Conflicts of interest All authors would like to disclose a conflict of interest directly related to work in the form of a grant for research time required from Baxter Pharmaceutical. Guarantor Dr. Adam Cristaudo. Research Registry Unique Identifying Number Research Registry UIN: researchregistry58. Acknowledgements We thank all the patients for participation in this study and Wesley Research Institute for the statistical support. References [1] K. McCormack, N.W. Scott, P.M. Go, et al., EU Hernia Trialists Collaboration. Laparoscopic technique versus open techniques for inguinal hernia repair, Cochrane Database Syst. Rev. (1) (2003) CD001785. [2] R. Bittner, T. Schwarz, Inguinal hernia repair; current surgical techniques, Langenbecks Arch. Surg. 397 (2) (2012) 271e282. [3] Z. Bobo, W. Nan, Q. Qin, W. Tao, L. Jianguo, H. Xianli, Meta-analysis of randomized controlled trials comparing Lichtenstein and totally extraperitoneal laparoscopic hernioplasty in treatment of inguinal hernias, J. Surg. Res. 192 (2) (2014 Dec) 409e420, http://dx.doi.org/10.1016/j.jss.2014.05.082. Epub 2014 Jun 4. [4] B.T. Heniford, A.L. Walters, A.E. Lincourt, Y.W. Novitsky, W.W. Hope, K.W. Kercher, Comparison of generic versus specific quality-of-life scales for mesh hernia repairs, J. Am. Coll. Surg. 206 (4) (2008 Apr) 638e644. [5] R Development Core Team, R: A Language and Environment for Statistical Computing, the R Foundation for Statistical Computing, Vienna, Austria, 2009, ISBN 3-900051-07-0. Available online at: http://www.R-project.org/. [6] J.L. Dulucq, Treatment of inguinal hernias by insertion of mesh through retroperitoneoscopy, Post. Grad. General Surg. 4 (1992) 173e174. [7] R. Bittner, M.I. Arregui, T. Bisgaard, et al., Guidelines for laparoscopic (TAPP) and TEPP treatment of inguinal hernia (International Endohernia Society IEHS), Surg. Endosc. 25 (2011) 2773e2843. [8] J. Treadwell, K. Tipton, O. Oyesanmi, F. Sun, K. Schoelles, Surgical Options for Inguinal Hernia: Comparative Effectiveness Review, Comparative Effectiveness Review No. 70. (Prepared by the ECRI Institute Evidence-based Practice Center under Contract No. 290-2007-10063.) AHRQ Publication No. 12EHC091-EF, Agency for Healthcare Research and Quality, Rockville, MD, August 2012. Available from: http://www.effectivehealthcare.ahrq.gov/ reports/final.cfm. [9] K. McCormack, B. Wake, J. Perez, et al., Laparoscopic surgery for inguinal hernia repair: systemic review of effectiveness and economic evaluation, Health Technol. Assess. 9 (2) (2005) 109e114. [10] Y. El-D Huwaib, D. Corless, C. Emmett, et al., Laparoscopic versus open repair of inguinal hernia: longitudinal cohort study, Surg. Endosc. 27 (3) (2012) 936e945. [11] V. Schumpchick, U. Klinge, R. Rosch, et al., Light weight meshes in incisional hernia repair, J. Min. Access Surg. 3 (2006) 117e123. n, M. Rodríguez, N. García-Honduvilla, G. Pascual, J. Buj [12] J.M. Bello an, Partially absorbable meshes for hernia repair offer advantages over non absorbable meshes, Am. J. Surg. 194 (1) (2007 Jul) 68e74. [13] U. Bokeler, J. Schwarz, R. Bittner, et al., Teaching and training in laparoscopic inguinal hernia repair (TAPP): impact of learning curve on patient outcome, Surg. Endosc. 27 (8) (2013) 2886e2893. [14] European hernia society guidelines on the treatment of inguinal hernia in adult patients, Hernia 13 (2009) 343e403. [15] B. Novik, S. Hagedown, U.B. Mork, et al., Fibrin glue for securing the mesh in laparoscopic totally extraperitoneal inguinal hernia repair, Surg. Endosc. 20 (3) (2006) 462e467. [16] R. Schwab, O. Schwacher, Junge, et al., Biomechanical analysis of mesh fixation in TAPP and TEPP hernia repair, Surg. Endosc. 22 (3) (2008) 731e738. [17] D.J. Byrne, J. Hardy, R. Wood, et al., Effect of fibrin glue in the mechanical properties of healing wounds, Br. J. Surg. 78 (1991) 841e843. [18] A. Krishna, M.C. Misra, V. Bansal, et al., Laparoscopic inguinal hernia repair: TAPP versus TEPP approach: a prospective randomised controlled trial, Surg. Endosc. 26 (3) (2012) 639e649. [19] S. Nienhuijs, E. Stall, L. Strobbe, et al., Chronic pain after mesh repair of inguinal hernia: a systemic review, Am. J. Surg. 194 (3) (2007) 394e400. [20] S. Bringman, J. Conze, D. Cuccurullo, J. Deprest, K. Junge, B. Klosterhalfen, et al.,

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