Abstract. Med. J. Cairo Univ., Vol. 82, No. 1, September: ,

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1 Med. J. Cairo Univ., Vol. 82, No. 1, September: , Evaluation of the Use of Low-Density Composite Prosthetic Material Mesh in Treating Large Abdominal Wall Incisional Hernias: A Prospective Clinical Study MOHAMED M. OSMAN, M.D. and WALID ABD EL MAKSOUD, M.D., M.R.C.S. The Department of General Surgery, Faculty of Medicine, Alexandria University, Egypt Abstract Objective: To evaluate the use of low-density composite prosthetic material ProceedTM mesh in management of large abdominal wall incisional hernias in adults with an intraperitoneum onlay method in terms of hernia recurrence. Methods: The study included 22 adult patients suffering from large abdominal incisional hernia with abdominal defect ^! 10cm who were admitted to General Surgery Department, Alexandria Main University Hospital (June 2009-December 2011). All patients were operated by intra-peritoneum onlay method using ProceedTM mesh and followed-up for one year. Recurrence was the primary endpoint of the study. Secondary endpoints included seromaformation and superficial wound infection as early postoperative complications, deep surgical site infection, adhesive intestinal obstruction and chronic pain as late postoperative complications. Results: Recurrence occurred in two patients (9.1%). Univariate analysis revealed that size of the defect and surgical site infection are significant risk factors for recurrence. Seroma occurred in 6 patients (27.3%). Superficial wound infection occurred in two patients (9.1%). Two patients (9.1%) had deep surgical site infection that was controlled conservatively, but resulted in recurrence in both patients. Reoperation for recurrence was performed in one of them and no dense adhesions were found between the mesh and underlying viscera. Chronic postoperative pain showed significant improvement with time at 3, 6 and 12 months. None of the cases had adhesive intestinal obstruction. Conclusions: After one year follow-up, proceedtm mesh seems a good choice to be used in open intra-peritoneum repair technique for a large abdominal wall defect. It seems to be effective and safe as its use was not associated with major complications. Key Words: Proceed mesh Incisional hernia Intraperitoneum onlay method Recurrence. Correspondence to: Dr. Walid Abd El Maksoud, The Department of General Surgery, Faculty of Medicine, Alexandria University, Egypt Introduction REPAIR of large abdominal wall defectsremains a challenging surgical problem [1]. The term defects of abdominal wall include a great variety of fascial defects; epigastric, umbilical, Spigelian and incisional hernias. Among these, incisional hernias are the most frequent ones, with a reported incidence of 10-20% as a complication for patients who underwent a laparotomy [2,3]. About a third of these patients experience serious discomfort, aesthetic complaints, intestinal obstruction or acute strangulation necessitatinghernia repair [4]. Hernia recurrence is among the most troublesome outcomes after hernia repair. Recurrence rate had decreased from 25-52% with primary repair to 13-19% with the use of prosthetic meshes [5]. However, the use of prosthetic mesh for repair of large abdominal wall defects was associated with significant morbidity related to the direct contact between the mesh and abdominal viscera, which cannot always be avoided [6]. The inflammatory reaction initiated by the mesh can lead to adhesions or even fistula formation [7]. Furthermore, closure of such large defect will carry great risk on cardiovascular and respiratory system. Technical advances in recent years have introduced a new generation of prostheses containing a lesser proportion of material (low weight or low density) and offering improved wall behavior in terms of minimizing adhesions between the mesh and abdominal viscera [2,8]. ProceedTM mesh is a new mesh, which consisted of a non-absorbable polypropylene layer and an absorbable layer of oxidized regenerated cellulose 629

2 630 Evaluation of the Use of Low-Density Composite Prosthetic Material Mesh (ORC), with a layer of polydioxanone (PDS) between them. The intentof the polypropylene side of the mesh is to allow adequate tissue in growth, whereas the ORC should provide a bioresorbable layer that physically separates the polypropylene from the underlying tissue and organ surfaces in order to minimize tissue attachment. The PDS film provides a thin flexible bond between the mesh and the ORC. As the ORC and PDS layers are bioresorbable, namely, after ingrowth of the polypropylene, the mesh contains much less polypropylene and can be considered as a light weight mesh or maybe better as a large-pore mesh [2]. However, the use of composite mesh has not been fully established [6]. The aim of this study was to evaluate the use of ProceedTM mesh in management of large abdominal wall incisional hernias in adults with an intraperitoneum onlay method in terms of recurrence. Patients and Methods The study included all adult patients suffering from large abdominal incisional hernia with abdominal defect > 1 0cm who were admitted to General Surgery Department, Alexandria Main University Hospital during the period June December Minimal sample size needed was calculated to be 22. The calculation was based on α error of 0.05, power of 0.90 (assuming prevalence 3-9%). It was calculated by using Statcalc-EpiInfo (version 6). Patients with defects less than 10cm, patients requiring emergency surgery, and patients with risk of sepsis (wound infection, or injury of the bowel reaching its lumen during dissection) were excluded from the study. An Informed consent was taken from all patients as regards the surgery as well as sharing in the research. Preoperative work up: Preoperative assessment and treatment of any predisposing factors was performed. Pre-operative data includingtype of previous surgical procedure and previous attempts of closure were collected. All patients were operated by the same team of consultants of general surgery with experience in the field of hernia repair. A dose of ceftriaxone (1 gm intravenous) was given to all patients just before induction of anesthesia. Operative work up: All patients were operated under general anesthesia. An elliptical incision was performed including the previous scar tissue. Dissection of lateral skin flaps till the fascial margins were defined clearly. The peritoneal cavity is then opened, adhesions were dissected (Fig. 1) and the defect size was assessed and measured in centimeters. Proceed mesh (Proceed Ethicon Inc., Somerville, NJ, USA) was used for abdominal reconstruction in all patients. The mesh was tailored to overlap the defect, with the specific side of the mesh covering the intestine, and its border exceeded 3cm beyond the defect margins in all directions. The ProceedTM mesh was fixed as an intra-peritoneum onlay method, and it was fixed with continuous sutures using 0 polypropylene circumferentially along the defect edge (Fig. 2) and reinforced by interrupted sutures. Two closed suction subcutaneous drains were inserted, then skin was primarily closed with clips in all patients. Outcomes: All patients were followed-up for 12 months. Primary end points: Recurrence was checked at 1, 3, 6 and 12 months by examination during follow-up visits at the outpatient clinic. Recurrence was defined as reappearance of a swelling at the site of operation proved clinically or radiologically (CT scan) to be hernia. Secondary end points: Operative time (in minutes) was measured by operative nurse at the time of operation. Early postoperative complications in the form of (early infection, seroma) by examination by the surgeon during follow-up visits in outpatient clinic. Seroma was defined as fluid collections that required drainage or caused symptoms. Wound infection was based on clinical aspect as erythema within one cm from the wound or pus discharge and microbiological culture. Time to regain domestic and work activities (days) noticed by the patient and recorded by the surgeon during visits of the patient to outpatient clinic. Chronic postoperative pain was measured by Modified Visual Analog Scale (VAS) [9] after 3,6 and 12 month at rest and with movement by the surgeon during follow-up visits in outpatient clinic. Surgical Site infection defined as infection occurring at the site of the operation up to one year after performing the operation detected by the attending surgeon in emergency room if it ever happens during the first 12 months after surgery.

3 Mohamed M. Osman & Walid Abd El Maksoud 631 Incidence of post-operative adhesive intestinal obstruction detected by the attending surgeon in emergency room if it ever happens during the first 12 months after surgery. Statistical analysis: Statistical analysis was done to detect risk factors affecting recurrence (as the main outcome) after repaire of incisional hernia, with large abdominal wall defect, using Proceed TM mesh, using Excel Program for figures and the Statistical Package for Social Sciences (SPSS, Inc, Chicago, IL, version 17). The description of data was done in the form of mean±sd for quantitative data and frequency and proportion for qualitativedata. Chi square test (for qualitative data) or t-test (for quantitative data) were and odds ratio for risk assessment. p-values were considered as statistically significant if <0.05. Results The study included 22 consecutive patients who underwent repair of incisional hernia with large abdominal wall defects using Proceed mesh applied in an intra-peritoneum onlay method. Patients were 7 men (31.8%) and 15 women (68.2%), with a mean age of ±8.90 years (range years). BMI of the patients was ±3.33 Kg/M 2 (range Kg/M 2 ). The mean size of the defect to be repaired was ±32.55cm 2 (range cm 2 ). Preoperative clinical data of patients are shown in Table (1). Mean operative time was ± minutes (range minutes). Minor injury to the serosa of the small bowel occurred in 3 patients (13.63%) and was repaired. Mean time of postoperative hospital stay was 7.64±3.11 days (range 5-17 days). Mean time to regain domestic activities was 7.68±3.55 days (range 7-19 days) while mean time to regain work activities was ±6.24 days (range days). Early and late postoperative complications are shown in Table (2). Chronic postoperative pain and discomfort was significantly improved (p<0.0001) with time from 3 to 6 months and also from 6 to 12 months. Mean VAS after 3 months was ±6.95 (range 7-34), after 6 months was 7.23 ±4.96 (range 3-22), and after 12 months was 3.77±2.67 (range 1-11). None of the patients developed adhesive intestinal obstruction during a follow-up period of 12 months. Analysis of risk factors (Table 3) revealed that defect size and deep surgical site infection as significant factorsaffecting recurrence. Table (1): Preoperative clinical criteria of the patients. Number of patients n=22 Percentage DM: Diabetics Non diabetics Previous surgical procedure: Abdomino-perineal resection Anterior resection Low anterior resection Colectomy Hysterectomy Nephrectomy Open cholecystectomy Abdominal exploration for acute abdomen Abdominal exploration for trauma Number of previousattempts: No attempts One attempt Two attempts Three attempts Four attempts Table (2): Early and delayed postoperative complications of the patients. Number of patients n=22 Percentage Early post-operative complications: Seroma Superficial wound infection Delayed post-operative complications: Recurrence Surgical site infection Adhesive intestinal obstruction 0 0 Table (3): Analysis of different risk factors affecting recurrence. Number of patients n=22 p-value Age ( Mean±SD) years 50.95± Sex (Male/Female) 7/ BMI (Mean±SD) Kg/M ± DM (number/%) 8 (36.4%) Number of previous attempts for repair (Mean±SD) 1.05± Operative time (Mean±SD) minutes ± Size of the defect (Mean±SD) cm ±32.55 <0.001 * Seroma formation (number/%) 6 (27.3%) Early superficial wound infection (number/%) Delayed surgical site infection (number/%) *p<0.05 is significant. 2 (9.1%) (9.1%) <0.001 *

4 632 Evaluation of the Use of Low-Density Composite Prosthetic Material Mesh Fig. (1): Abdominal defect after dissection of all adhesions. Fig. (2): Fixation of the preoceedtm mesh to the edges of the defect. Discussion Currently, synthetic mesh materials are commonly used to repair large abdominal defects. In addition to strengthening the weakened abdominal wall, they function in a tension-free manner which is essential to avoid abdominal compartment syndrome and to decrease the incidence of recurrence [10,11]. However, placement of mesh introduces additional morbidity regarding wound-related complications [12]. The ultimate goal of successful prosthetic repair of large abdominal defects is not only to minimize the recurrence rate, but also to have the lowest possible postoperative complications (e.g., inflammation, visceral adhesions and mesh erosion with consequent fistula). The early use of polypropylene mesh in an intra-abdominal placement was associated with high risk of adhesions to intra-abdominal viscera and entero-cutaneous fistula formation. Different types of mesh (Surgipro, Ultra-Pro, Vypro) have been placed in different layers (onlay, sublay, and intraperitoneal) in an attempt to achieve an optimal outcome in patients with large abdominal defects but none proved to be ideal [13]. The ideal mesh while repairing large abdominal defects should incite tissue to grow into the parietal surface, permit neoperitoneum formation on the visceral surface and minimize visceral adhesion formation [14]. ProceedTM mesh is a composite mesh, which was designed to have a side that can safely contact the viscera directly, sothe mesh could be used to repair large abdominal defects [15]. The reduced amount of introduced material and the large pore size of the ProceedTM mesh would adapt the mesh to the physiological demands resulting in a significant improvement in biocompatibility [16]. Previous experimental studies in animals have shown that ProceedTM mesh is completely covered by neoperitoneum within 14 days, the PDS laminas enveloping it disintegrate in 2 weeks and absorb within 3 months to allow tissue colonization [17]. Results of thefew studies in the literature on the use of ProceedTM mesh in humans are controversial. Jacob et al., [18] concluded that parietex composite mesh was superior to ProceedTM mesh regarding the visceral adhesions, fibrous ingrowth into the parietal surface and mesh shrinkage. Egea et al., [1] and Rosenberg [19] support the use of ProceedTM mesh, reporting that it has two basic characteristics: First, it allows excellent tissuecolonisation and the second one is the avoidance of adherence to the underlying viscera. Previous studies [2] reported fixation of the mesh to the edge of the defect with interrupted sutures, we believe continuous sutures and overlap of the mesh beyond the defect edge are safer to avoid escape of any intestinal loop with subsequent complications. Overlap of the mesh beyond the defect edge may be also necessary to avoid complications of mesh shrinkage which is a common disadvantage for most prosthetic meshes. It may be a possible reason for hernia recurrence after mesh repair. Burger [6] found that the shrinkage of meshes used intra-peritonium could be up to 50% in animal models. However, ProceedTM mesh has a good compliance and less liable to shrink due toits composite construction [2]. Early postoperative complications included seroma formation and superficial wound infection. Superficial wound infection occurred in two patients (9.1%) and managed conservatively with antibiotics and wound care. Seroma occurred in 6 patients (27.3%). It was diagnosed by clinical fullness and confirmed by Ultrasonography. Five patients were treated successfully with repeated ultrasound guided aspiration under complete aseptic measures followed by pressure dressing. One patient required ultrasound insertion of a new drain

5 Mohamed M. Osman & Walid A bd El Maksoud 633 that was removed after 6 weeks with no further complications. Liu et al., [2] reported a similarrate of seroma formation. Late postoperative complications included recurrence and deep surgical site infection. Recurrence was the main outcome of this study because of its high incidence after repairing large defects. Recurrence was reported in 2 patients (9.1%) in our study. Many studies analyzed risk factors affecting recurrence after hernia repair. Venclauskas et al., [20] found that BMI andsize of the defect are significant risk factors for recurrence. Bontinck et al., [21] found that size of the defect and not BMI is the risk factor for recurrence. Results of our study support that size of the defect is a significant risk factor affecting recurrence. This could be explained by the physical fact that pressure on the mesh will increase proportionally with the defect size. Also the area of attachment of the mesh to the edge of the defect will definitely increases with larger defect sizes which carries the potential risk of gaping and subsequent herniation. Surgical site infection was found to be another significant risk factor for recurrence in this study. Infection leads to separation of the mesh from the edge of the defect resulting in recurrence. Stremitzer et al., [22] reported a 6.5% incidence of deep surgical site infection involving the implanted mesh graft. Surgical site infection occurred in two of our patients (9. 1 %). Infection was controlled successfully with antibiotics but it resulted in recurrence in both cases. One patient refused further management while the other one was re-operated. During the second operation, adhesions were not dense and adhesolysis was easily performed. This finding supports the findings of Egea et al., [1] and Rosenberg [19] as regards amountadhesions between the proceed mesh and the underlying viscera. Chronic postoperative pain was reported in some series to be as high as 30% after incisional hernia repair [23,24]. Lui et al., [2] did not report chronic postoperative pain in his study. In this study, chronic postoperative pain showed significant improvement after 3, 6 and 12 months. We recommend to assess chronic postoperative pain after 12 months as our study showed significant improvement of chronic postoperative pain between 6 and 12 months. In conclusion, after one year of follow-up, ProceedTM mesh seems a good choice to be used in open intra-peritoneum repair technique for a large abdominal wall defect. It seems to be effective and safe as its use was not associated with major complications. However, furtherstudies with a greater number of patients, and long-term followup are required to support our results. Acknowledgements: Authors would like to thank Dr. Ossama A. Mostafa, Assistant Professor, Public Health Department, Beni Suef Faculty of Medicine and Dr. Ahmed Aboelyazid, Lecturer of Public Health and Community Medicine, Faculty of Medicine, Mansoura University for their sincere help in the statistical analysis for the data of this study. Conflicts of interests: None. References 1- MORENO-EGEA A., AGUAYO-ALBASINI J.L., BAL- LESTER M.M. and CASES BALDÓ M.J.: Treatment of Incisional Hernias Adopting an Intra-abdominal Approach With a New Low-density Composite Prosthetic Material: Proceed. Surg. Laparosc. Endosc. Percutan. Tech. Dec., 19 (6): , LIU F. and LI J.: Repair of large abdominal wall defects using the ProceedTM surgical mesh with open intraperitoniumonlay method. Saudi Med. J. May, 32 (5): 504-9, KINGSNORTH A. and LEBLANC K. HERNIAS: Inguinal and incisional. Lancet, 362: , BURGER J.W., LUIJENDIJK R.W., HOP W.C., HALM J.A., VERDAASDONK E.G. and JEEKEL J.: Long-term follow-up of a randomized controlled trial of suture versus mesh repair of incisional hernia. Ann. Surg., 240: , ELTAYEB A.A., IBRAHIM I.A. and MOHAMED M.B.: The use of PROCEED mesh in ventral hernias: A pilot study on 22 cases. Afr. J. Paediatr Surg., Jul. Sep., 10 (3): , BURGER J.W., HALM J.A., WIJSMULLER A.R., TEN RAA S. and JEEKEL J.: Evaluation of new prosthetic meshes for ventral hernia repair. Surg. Endosc., 20: , LEBER G.E., GARB J.L., ALEXANDER A.I. and REED W.P.: Long-term complications associated with prosthetic repair of incisional hernias. Arch. Surg., 133: , BAUER J.J., HARRIS M.T., KREEL I. and GELERNT I.M.: Twelve-year experience with expanded polytetrafluoroethylene in the repair of abdominal wall defects. Mt Sinai J. Med., 66: 20-5, GOULD D.: Information point: Visual Analogue Scale (VAS) J. Clin. Nurs., 10: 706, KO J.H., WANG E.C., SALVAY D.M., PAUL B.C. and DUMANIAN G.A.: Abdominal wall reconstruction: lessons learned from 200 components separation procedures. Arch. Surg., 144: , PEPPAS G., GKEGKES I.D., MAKRIS M.C. and FAL- AGAS M.E.: Biological mesh in hernia repair, abdominal

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