Alloderm hernia paper

Alloderm hernia paper

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  World J Surg DOI10.1007/s00268-011-1131-6 Does Prophylactic Biologic Mesh Placement Protect Against the Development of Incisional Hernia in High-risk Patients? O. H. Llaguna • D. V. Avgerinos • P. Nagda • D. Elfant • I. M. Leitman • E. Goodman Ó Societe Internationale de Chirurgie 2011 ´´ Abstract incisional hernia (mesh = 2, nonmesh = 2). The mean Background The purpose of this study was to determine follow-up period was 17.3 ± 8.5 months. The overall whether the prophylactic use of a biologic prosthesis pro- incidence of incisional hernia was 11.3% (95% CI: 5.2– tects against the development of incisional hernia in a high- 17.45). The incidence of incisional hernia was significantly risk patient population. lower in the mesh group versus the nonmesh group (2.3 vs. Methods A prospective, nonrandomized trial was con- 17.7%, P = 0.014). In a multivariate logistic regression ducted on 134 patients undergoing open Roux-en-Y gastric model that adjusted for age, sex, body mass index, albu- bypass by a single surgeon, at two institutions, from Jan- min, smoking, diabetes, prior surgery, seroma formation, uary 2005 to November 2007. At Hospital A, all patients weight loss, and mesh placement, the development of (n = 59) underwent fascial closure of the abdominal incisional hernia was found to be associated with smoking midline wound with the prophylactic placement of a bio- (adjusted odds ratio [OR] 8.46, 95% CI: 1.79–40.00, logic mesh (AlloDermÒ) in an in-lay fashion. Patients at P = 0.007) while prophylactic mesh was noted to be pro- Hospital B (n = 75) underwent primary abdominal wall tective against hernia development (adjusted OR 0.06, 95% closure using #1 PDS in a running fashion. Data collected CI: 0.006–0.69, P = 0.02). included patient demographics, abdominal wall closure Conclusion The prophylactic use of biologic mesh for technique, postoperative wound complications, follow-up abdominal wall closure appears to reduce the incidence of period, and incidence of incisional hernia. incisional hernia in patients with multiple risk factors for Results During the study period 134 patients (mean incisional hernia development. age = 40.4 years, 80.7% female) underwent open Roux-en-Y gastric bypass (59.7% mesh, 41.5% nonmesh). Twenty- eight patients were excluded from the analysis secondary to Introduction a short follow-up period (mesh = 13, nonmesh = 11) and/ or reoperative surgery unrelated to the development of an The traditionally recommended method of abdominal wall closure following laparotomy includes the use of a non- absorbable or slowly absorbing running suture with a 1 cm Presented at the 4th Annual Academic Surgical Congress, Fort Myers, FL, February 3-6 2009. distance between stitches and the fascial margin. Despite technical improvement and adherence to principles, the O. H. Llaguna (&) overall incidence of incisional hernia following laparotomy Division of Surgical Oncology and Endocrine Surgery, remains reported to be between 11 and 23% [1–3]. University of North Carolina, 170 Manning Drive, 1150 Physicians Office Building, Chapel Hill, NC 27599, USA Although patient-related risk factors such as a history of e-mail: [email protected] smoking, morbid obesity, pulmonary disease, abdominal aortic aneurysmal disease, prior abdominal surgery, or D. V. Avgerinos Á P. Nagda Á D. Elfant Á surgical site infections [4] cannot be controlled, modifica- I. M. Leitman Á E. Goodman Department of Surgery, Beth Israel Medical Center, tions in the standard abdominal wall closure in pre-iden- Albert Einstein College of Medicine, New York, NY, USA tified high-risk patient populations may reduce the 123
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  World J Surg incidenceof postoperative incisional hernias. One simple visible protrusions at or near the surgical incision at rest or and feasible modification may be the prophylactic place- with valsalva. Imaging studies were performed only when ment of subfascial prosthetic materials at the time of initial clinically warranted. Data collected included patient demo- laparotomy. graphics, abdominal wall closure technique (mesh versus While many studies validate the use of mesh for inci- nonmesh), postoperative wound complications, follow-up sional hernia repair [5–11], few attempt to prove its use- period, and incidence of incisional hernia. Data were analyzed fulness in the prophylaxis of incisional hernia using SPSS for Windows v16 (SPSS Inc., Chicago, IL). A development. Although limited, the available data suggest P value less than 0.05 was considered statistically significant. that the prophylactic use of a nonabsorbable mesh at the time of initial laparotomy confers protection against hernia development [12–16]. Surgeons, however, are appropri- Results ately hesitant to adopt this practice, citing the paucity of data demonstrating the proposed technique’s effectiveness During the study period, 134 patients (mean age = 40.4 years, and concerns about the placement of permanent mesh at the 80.7% female) underwent open Roux-en-Y gastric bypass time of a potentially contaminated case. To help nullify (44% mesh, 56% nonmesh). Twenty-eight patients were these concerns, we suggest that AlloDermÒ (LifeCell excluded from the analysis secondary to a short follow-up Corp., Branchburg, NJ), a biologic acellular matrix pros- period (mesh = 13, nonmesh = 11) and/or reoperative thetic mesh that has been found to be safe to use in con- surgery unrelated to the development of an incisional taminated cases [17, 18], may be ideal for prophylactic hernia (mesh = 2, nonmesh = 2). The mean follow-up mesh placement, obviating the concern for infectious period was 17.3 ± 8.5 months (mesh, 16.6 ± 7.1; non- complications. The purpose of this study was to determine mesh, 17.7 ± 9.4, P = 0.50). No significant difference whether the prophylactic use of a biologic mesh is pro- was noted between the mesh and nonmesh groups with tective against the development of incisional hernia in a regard to age (P = 0.06), gender (P = 0.10), preoperative high-risk patient population, and if so, is it at the cost of body mass index (BMI) (P = 0.26), total weight loss added morbidity. (P = 0.53), diabetes (P = 0.89), sleep apnea (P = 0.22), asthma (P = 0.06), exertional dyspnea (P = 0.12), depression (P = 0.65), hypertension (P = 0.36), degener- Methods ative joint disease (P = 0.94), smoking (P = 0.31), and wound infection (P = 0.07) (Table 1). Patients in the A prospective, nonrandomized trial was conducted on 134 nonmesh group were more likely to have undergone prior patients undergoing open Roux-en-Y gastric bypass by a abdominal surgery (P = 0.001), while those in the mesh single surgeon, at two institutions, from January 2005 to group had an overall lower postoperative BMI (P = 0.05) November 2007. At Hospital A, all patients (n = 59, 44%) at the time of last follow-up. The overall incidence of in- received prophylactic placement of a biologic mesh (Allo- cisional hernia was 11.3% (95% CI: 5.19–17.45). The Derm) in an in-lay fashion during abdominal wall closure as incidence of incisional hernia was significantly lower in the an institutionally approved internal review board protocol. A mesh group (mesh: 2.3%, 95% CI: -2.31-6.86; nonmesh: 16 cm 9 6 cm piece of mesh was routinely used. Given the 17.7%, 95% CI: 7.96–27.52, P = 0.01), while the inci- biologic mesh’s flexibility and smooth texture, which makes dence of seroma was lower in the nonmesh group (mesh, handling difficult, a moistened medium-sized malleable rib- 13.64%; nonmesh, 1.64%, P = 0.01) (Table 1). In a mul- bon was placed underneath and used for positioning and sta- tivariate logistic regression model that adjusted for age, bilization. The mesh was placed below the fascia with several sex, BMI, albumin, smoking, diabetes, prior surgery, ser- interrupted #1 polydioxanone sulfate (PDSÒ, Ethicon, Som- oma formation, weight loss, and mesh placement, hernia erville, NJ) monofilament sutures, and the fascia was closed in was found to be associated with smoking (adjusted odds a primary running fashion also with #1 PDS with a 1 cm ratio [OR] 8.46, 95% CI: 1.79–40.00, P = 0.008) while distance between stitches and the fascial margin. Patients at prophylactic mesh was noted to be protective against Hospital B (n = 75, 56%) underwent primary abdominal wall incisional hernia development (adjusted OR: 0.06, 95% closure using #1 PDS in a similar running fashion. At both CI: 0.006–0.69, P = 0.02) (Table 2). institutions the primary surgeon performed the entire abdominal wall closure to minimize variability in technique. Routine follow-up consisted of laboratory work, weight loss Discussion assessment, and physical examination 1 week after discharge, monthly for 3 months, then every 6 months for 2 years. Since its first description in 1975 by Dr. Rene Stoppa, an Incisional hernias were defined as a palpable fascial defect or abundance of data has emerged supporting the superiority 123
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  World J Surg Table1 Patient demographics Variable Nonmesh [62 (58.5%)] Mesh [44 (41.5%)] P valuea and characteristics n (%) n (%) Age (mean ± SD) 39.39 ± 11.08 43.73 ± 11.81 0.06 Gender 0.10 Male 10 (16.13%) 13 (29.55%) Female 52 (83.87%) 31 (70.45%) Preoperative BMI (mean ± SD) 50.38 ± 9.31 52.58 ± 10.59 0.26 Postoperative BMI (mean ± SD) 33.48 ± 8.56 36.75 ± 7.73 0.05 Weight loss (mean ± SD) 103.25 ± 63.74 96.18 ± 46.16 0.53 Preoperative albumin (mean ± SD) 4.04 ± 0.32 3.92 ± 0.26 0.14 Diabetes 21 (33.87%) 14 (32.56%) 0.89 Sleep apnea 12 (19.35%) 13 (29.55%) 0.22 Asthma 18 (29.03%) 6 (13.64%) 0.06 Hypothyroidism 4 (6.75%) 5 (11.36%) 0.37 Exertional dyspnea 23 (37.10%) 10 (22.73%) 0.12 Prior abdominal surgery 33 (54.10%) 10 (22.73%) 0.001 Depression 15 (24.19%) 9 (20.45%) 0.65 Hypertension 31 (50.00%) 18 (40.91%) 0.36 Degenerative joint disease 58 (93.55%) 41 (93.18%) 0.94 Smoking 0.31 No 49 (79.03%) 31 (70.45%) Yes 13 (20.97%) 13 (29.55%) Incisional hernia 11 (17.74%) 1 (2.27%) 0.01 Wound infection 1 (1.61%) 4 (9.09%) 0.07 Seroma 1 (1.61%) 6 (13.64%) 0.01 a Follow-up period (mean ± SD) 17.72 ± 9.39 16.59 ± 7.05 0.50 Fisher’s exact test of tension-free mesh repair over primary suture repair in the primary abdominal wall closure or supra-aponeurotic management of incisional hernias [5–11]. At present, ten- polypropylene mesh placement. At 3-year follow-up, five sion-free mesh repair is standard in the operative manage- patients in the nonmesh group had developed incisional ment of incisional hernias, having proven to be efficacious hernias while all in the mesh group were without hernia even in the face of multiple non-modifiable patient-related (P = 0.02) [15]. In contrast to these positive findings, Pan risk factors, decreasing the incidence of recurrence by as et al. [19] were unable to show any reduction in incisional much as 50% in some series [10]. From this success and hernia development with the prophylactic use of a fostered by an era of newer biologic mesh that can safely be polyglactin mesh. Their study, however, differs dramati- used in spite of intra-abdominal contamination, the question cally from the other cited studies in that an absorbable arises: Can abdominal wall closure with permanent mesh be mesh was used, placed intraperitoneally without fixation, similarly used to prevent, rather than repair, incisional and the overlying fascia was approximated with interrupted hernias? Some of the data are promising. absorbable suture [19]. Strzelczyk et al. [13], in a nonrandomized prospective The incisional hernia rate following nonmesh closure in study of patients who underwent open Roux-en-Y gastric our series was 17.7%, a rate similar to that reported in the bypass, found no hernias in the prophylactic mesh group literature [1–3, 20]. Patients who received prophylactic (n = 12) and nine in the standard closure group (n = 48). mesh placement, however, experienced a significantly A follow-up randomized controlled study by Strzelczyk lower incisional hernia rate (2.3%), with the only added et al. [14] again found that none of the patients assigned to morbidity being increased seroma formation (mesh, 13.6%; the prophylactic polypropylene mesh group (n = 36) nonmesh, 1.6%, P = 0.01). However, seroma formation developed incisional hernias while one-fifth of those in the following hernia repair with mesh is a common occurrence, primary closure group (n = 38) did. Similarly, Gutierrez´ with some laparoscopic series reporting a 35% incidence ˜ de la Pena et al. [15] found prophylactic polypropylene discovered clinically, and a 100% found on subsequent mesh placement to be protective against incisional hernia ultrasonic evaluation [21]. These findings have led many to development when they randomized a 100 patients to either consider it an expected mesh-related reaction rather than a 123
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  World J Surg Table2 Comparison of the Variable Hernia group Nonhernia group P valuea hernia and nonhernia groups [12 (11.3%)] [94 (88.7%)] n (%) n (%) Biologic mesh use 1 (8.33%) 43 (45.74%) 0.01 Follow-up period (mean ± SD) 18.01 ± 9.51 17.16 ± 8.03 0.47 Age (mean ± SD) 39.75 ± 12.75 41.37 ± 11.47 0.64 Gender 0.46 Male 1 (8.33%) 22 (23.40%) Female 11 (91.67%) 72 (76.60%) Preoperative BMI (mean ± SD) 53.36 ± 7.54 51.03 ± 10.13 0.44 Postoperative BMI (mean ± SD) 33.13 ± 7.29 35.06 ± 8.49 0.45 Weight loss (mean ± SD) 125.75 ± 38.73 97.07 ± 58.24 0.10 Preoperative albumin (mean ± SD) 3.87 ± 0.31 4.01 ± 0.30 0.13 Diabetes 6 (50.00%) 29 (31.18%) 0.21 Sleep apnea 1 (8.33%) 24 (25.53%) 0.29 Asthma 2 (16.67%) 22 (23.40%) 0.73 Prior abdominal surgery 6 (50.00%) 37 (39.78%) 0.54 Smoking 0.008 No 5 (41.67%) 75 (79.79%) Yes 7 (58.33%) 19 (20.21%) Wound infection 0 (0.00%) 5 (5.32%) 1.00 BMI Body mass index a Seroma 1 (8.33%) 6 (6.38%) 0.58 Fisher’s exact test complication, a small price to pay for a sturdier repair or in risk factors for incisional hernia development such as our case a diminutive incisional hernia rate. diabetes, morbid obesity, and a history of smoking. Fur- Given the current emphasis on health-care cost con- thermore, as the price of biologic mesh declines, the tainment, novel interventions need not only be safe and observed improvement in incisional hernia rate may not efficacious but also financially responsible prior to their only translate to better patient care, but also into overall adoption. Simply stated, is a potential improvement in cost containment. The conclusions from this study will be incisional hernia rate worth the additional expense associ- more compelling in the future with a larger sample size, ated with routine biologic mesh placement? Although a prospective randomization, and thorough cost analysis. formal cost analysis was not conducted, routine use of a biologic mesh in high-risk patients may be a financially desirable proposition. Of the 12 incisional hernias identi- References fied, 9 were symptomatic requiring repair. Taking into account the cost of biologic mesh (44 patients 9 1. Mudge M, Hughes LE (1985) Incisional hernia: a ten year pro- $1,700 = $77,000) and the average cost of an incisional spective study of incidence and attitudes. Br J Surg 72:70–71 hernia repair ($16,947) [22], in our cohort a 15.4% 2. Bucknall TE, Cox PJ, Ellis H (1982) Burst abdomen and inci- sional hernia: a prospective study of 1129 major laparotomies. Br reduction in incisional hernia rate (6.7 hernia repairs Med J (Clin Res Ed) 284(6364):519–520 avoided = $113,544 savings) came with an additional 3. Livingston EH (2005) Complications of bariatric surgery. Surg $36,544 in savings. This estimate is conservative seeing Clin North Am 85:853–868 that it fails to take into account wages lost by patients, costs 4. Shell DH, de la Torre J, Andrades P, Vasconez LO (2008) Open repair of ventral incisional hernias. Surg Clin North Am 88(1): associated with failed hernia repairs, and more importantly 61–83 the emotional and physical duress of patients who undergo 5. George CD, Ellis H (1986) The results of incisional hernia repair: a second operation. a twelve year review. Ann R Coll Surg Engl 68:185–187 This is the first study to demonstrate the benefit obtained 6. Stoppa RE (1989) The treatment of complicated groin and inci- sional hernias. World J Surg 13:545–554. doi:10.1007/ from prophylactic biologic mesh placement at the time of BF01658869 midline laparotomy in patients at high risk for the devel- 7. Leber GE, Garb JL, Alexander AI, Reed WP (1998) Long-term opment of incisional hernia. Although the study was lim- complications associated with prosthetic repair of incisional ited to patients undergoing open Roux-en-Y gastric bypass, hernias. Arch Surg 133:378–382 we believe these results apply to patients with recognized 123
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