Multicenter, Prospective, Longitudinal Study of the Recurrence, Surgical Site Infection, and Quality of Life After Contaminated Ventral Hernia Repair Using Biosynthetic Absorbable Mesh: The COBRA Study

Michael J Rosen, Joel J Bauer, Marco Harmaty, Alfredo M Carbonell, William S Cobb, Brent Matthews, Matthew I Goldblatt, Don J Selzer, Benjamin K Poulose, Bibi M E Hansson, Camiel Rosman, James J Chao, Garth R Jacobsen, Michael J Rosen, Joel J Bauer, Marco Harmaty, Alfredo M Carbonell, William S Cobb, Brent Matthews, Matthew I Goldblatt, Don J Selzer, Benjamin K Poulose, Bibi M E Hansson, Camiel Rosman, James J Chao, Garth R Jacobsen

Abstract

Objective: The aim of the study was to evaluate biosynthetic absorbable mesh in single-staged contaminated (Centers for Disease Control class II and III) ventral hernia (CVH) repair over 24 months.

Background: CVH has an increased risk of postoperative infection. CVH repair with synthetic or biologic meshes has reported chronic biomaterial infections and high hernia recurrence rates.

Methods: Patients with a contaminated or clean-contaminated operative field and a hernia defect at least 9 cm had a biosynthetic mesh (open, sublay, retrorectus, or intraperitoneal) repair with fascial closure (n = 104). Endpoints included overall Kaplan-Meier estimates for hernia recurrence and postoperative wound infection rates at 24 months, and the EQ-5D and Short Form 12 Health Survey (SF-12). Analyses were conducted on the intent-to-treat population, and health outcome measures evaluated using paired t tests.

Results: Patients had a mean age of 58 years, body mass index of 28 kg/m, 77% had contaminated wounds, and 84% completed 24-months follow-up. Concomitant procedures included fistula takedown (n = 24) or removal of infected previously placed mesh (n = 29). Hernia recurrence rate was 17% (n = 16). At the time of CVH repair, intraperitoneal placement of the biosynthetic mesh significantly increased the risk of recurrences (P ≤ 0.04). Surgical site infections (19/104) led to higher risk of recurrence (P < 0.01). Mean 24-month EQ-5D (index and visual analogue) and SF-12 physical component and mental scores improved from baseline (P < 0.05).

Conclusions: In this prospective longitudinal study, biosynthetic absorbable mesh showed efficacy in terms of long-term recurrence and quality of life for CVH repair patients and offers an alternative to biologic and permanent synthetic meshes in these complex situations.

Conflict of interest statement

The authors report no conflicts of interest.

Figures

FIGURE 1
FIGURE 1
Kaplan-Meier estimate of freedom from postoperative hernia recurrence: all participants (n remaining at risk = 85 and 74 patients at 12 and 24 months, respectively).
FIGURE 2
FIGURE 2
Change in SF-12 physical score from baseline stratified by hernia recurrence during study (n = 10 for patients with hernia recurrence evaluated at 12 and 24 months; n = 55 and 49 for patients without hernia recurrence evaluated at 12 and 24 months, respectively). SF-12 indicates Short Form 12 Health Survey.

References

    1. Cobb WS, Carbonell AM, Kalbaugh CL, et al. Infection risk of open placement of intraperitoneal composite mesh. Am Surg 2009; 75:762–767.
    1. Hawn MT, Snyder CW, Graham LA, et al. Long-term follow-up of technical outcomes for incisional hernia repair. J Am Coll Surg 2010; 210:648–655.
    1. Luijendijk RW, Hop WC, van den Tol MP, et al. A comparison of suture repair with mesh repair for incisional hernia. N Eng J Med 2000; 343:392–398.
    1. Park AE, Roth JS, Kavic SM. Abdominal wall hernia. Curr Probl Surg 2006; 43:326–375.
    1. Baillie DR, Stawicki SP, Eustance N, et al. Use of human and porcine dermal-derived bioprostheses in complex abdominal wall reconstructions: a literature review and case report. Ostomy Wound Manage 2007; 53:30–37.
    1. Breuing K, Butler CE, Ferzoco S, et al. Ventral Hernia Working Group. Incisional ventral hernias: review of the literature and recommendations regarding the grading and technique of repair. Surgery 2010; 148:544–558.
    1. Rosen MJ, Krpata DM, Ermlich B, et al. A 5-year clinical experience with single-staged repairs of infected and contaminated abdominal wall defects utilizing biologic mesh. Ann Surg 2013; 257:991–996.
    1. Burns NK, Jaffari MV, Rios CN, et al. Non-cross-linked porcine acellular dermal matrices for abdominal wall reconstruction. Plast Reconstr Surg 2010; 125:167–176.
    1. Itani KM, Rosen M, Vargo D, et al. RICH Study Group. Prospective study of single-stage repair of contaminated hernias using a biologic porcine tissue matrix: the RICH Study. Surgery 2012; 152:498–505.
    1. Kim H, Bruen K, Vargo D. Acellular dermal matrix in the management of high-risk abdominal wall defects. Am J Surg 2006; 192:705–709.
    1. Katz AR, Mukherjee DP, Kaganov AL, et al. A new synthetic monofilament absorbable suture made from polytrimethylene carbonate. Surg Gynecol Obstet 1985; 161:213–222.
    1. Mangram AJ, Horan TC, Pearson ML, et al. Guideline for prevention of surgical site infection, Hospital Infection Control Practices Advisory Committee. Infect Control Hosp Epidemiol 1999; 20:250–278.
    1. Muysoms FE, Miserez M, Berrevoet F, et al. Classification of primary and incisional abdominal wall hernias. Hernia 2009; 13:407–414.
    1. Stoppa RE. The treatment of complicated groin and incisional hernias. World J Surg 1989; 13:545–554.
    1. Kanters AE, Krpata DM, Blatnik JA, et al. Modified hernia grading scale to stratify surgical site occurrence after open ventral hernia repairs. J Am Coll Surg 2012; 215:787–793.
    1. Ware J, Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care 1996; 34:220–233.
    1. EuroQol Group. EuroQol: a new facility for the measurement of health-related quality of life. Health Policy 1990; 16:199–208.
    1. de Vries Reilingh TS, van Goor H, Charbon JA, et al. Repair of giant midline abdominal wall hernias: “components separation technique” versus prosthetic repair: interim analysis of a randomized controlled trial. World J Surg 2007; 31:756–763.
    1. Rosen MJ, Denoto G, Itani KM, et al. Evaluation of surgical outcomes of retro-rectus versus intraperitoneal reinforcement with bio-prosthetic mesh in the repair of contaminated ventral hernias. Hernia 2013; 17:31–35.
    1. Helgstrand F, Rosenberg J, Kehlet H, et al. Nationwide prospective study of outcomes after elective incisional hernia repair. J Am Coll Surg 2013; 216:217–228.
    1. de Vries Reilingh TS, Bodegom ME, van Goor H, et al. Autologous tissue repair of large abdominal wall defects. Br J Surg 2007; 94:791–803.
    1. Reynolds D, Davenport DL, Korosec RL, et al. Financial implications of ventral hernia repair: a hospital cost analysis. J Gastrointest Surg 2013; 17:159–166.
    1. Poulose BK, Shelton J, Phillips S, et al. Epidemiology and cost of ventral hernia repair: making the case for hernia research. Hernia 2012; 16:179–183.
    1. Carbonell AM, Criss CN, Cobb WS, et al. Outcomes of synthetic mesh in contaminated ventral hernia repairs. J Am Coll Surg 2013; 217:991–998.
    1. Petro CC, Nahabet EH, Criss CN, et al. Central failures of lightweight monofilament polyester mesh causing hernia recurrence: a cautionary note. Hernia 2015; 19:155–159.
    1. Conze J, Kingsnorth AN, Flament JB, et al. Randomized clinical trial comparing lightweight composite mesh with polyester or polypropylene mesh for incisional hernia repair. Br J Surg 2005; 92:1488–1493.

Source: PubMed

Sponsorit ja yhteistyökumppanit

Sairaudet

Huumeiden interventiot

3
Tilaa