- Email: [email protected]
Repair of large abdominal incisional hernia by reconstructing the midline and use of an onlay of biological material
The American Journal of Surgery (2011) 202, e7– e11
How I Do It
Repair of large abdominal incisional hernia by reconstructing the midline and use of an onlay of biological material Massimiliano Tuveri, M.D.a,*, Augusto Tuveri, M.D.a, Enrico Nicolò, M.D., F.A.C.S., F.I.C.S.b a
Department of General Surgery, Sant’Elena Clinic, viale Marconi 160, 09045 Quartu, Sant’Elena, Cagliari, Italy; Department of General Surgery, Jefferson Regional Medical Center, Pittsburgh, PA, USA
b
KEYWORDS: Incisional hernia; Surgical repair; Biological material; Recurrence; Midline
Abstract BACKGROUND: The aim of this study was to determine the feasibility and efficacy of repairing large abdominal incisional hernias by reconstructing the midline using bilateral abdominis rectus muscle sheath (ARS) relaxing incisions and a biological material onlay. METHODS: Between January 2002 and December 2008, 71 patients underwent repair of large incisional hernias at 2 community hospitals. After replacement of hernia sac contents into the peritoneal cavity, a relaxing incision was made in the ARS bilaterally. Then, the midline was closed primarily. The biological material was used as an onlay and sutured to the lateral edges of the relaxed ARS. Main outcome measures were postoperative complications and hernia recurrence. RESULTS: Median defect size was 195 cm2 (range, 150 – 420 cm2), median surgical time was 125 minutes, and median hospital stay was 6 days. There were no deaths and no wound infections. Wound seroma, the most frequent postoperative complication, occurred in 51 (72%) of the 71 patients. There was 1 (1.4%) recurrence. CONCLUSIONS: In these 71 patients, our technique for repair of large abdominal incisional hernias was safe and effective. © 2011 Elsevier Inc. All rights reserved.
Incisional hernia is an iatrogenic event, a consequence of surgical failure.1 Repair of an abdominal incisional hernia is complex and difficult and should be considered a major and challenging surgical procedure.2– 4 The main principle of abdominal incisional hernia repair is to restore the anatomic and physiologic integrity of the abdominal wall by reconstructing the midline.5,6 Ideally, midline structural support is restored by midline approximation of local musculoapo* Corresponding author. Tel.: ⫹39-70-371117; fax: ⫹39-70-837391. E-mail address: [email protected] Manuscript received October 8, 2009; revised manuscript June 21, 2010
0002-9610/$ - see front matter © 2011 Elsevier Inc. All rights reserved. doi:10.1016/j.amjsurg.2010.06.005
neurotic tissues (rectus muscle and fascia) with good blood and nerve supply. Approximation of native musculoaponeurotic tissue without tension on the suture line will restore the elasticity and flexibility of the abdominal wall (ie, its ability to actively contract and passively relax). Smaller defects (ⱕ6 cm in diameter) can be repaired successfully by medial advancement of the rectus abdominis muscles. However, 30% to 50% of defects larger than 6 cm recur after primary closure7–10 because the edges of the defect cannot be approximated without tension on the suture line. Insertion of an alloplastic material to decrease or eliminate tension on the suture line can reduce the incidence of recurrence to 10% or less.10 –16 However, inorganic pros-
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thetic materials have been associated with a high risk of complications such as protrusion, extrusion, infection, and intestinal fistulization.17–20 Most importantly, inorganic materials are rigid, passive, and adynamic, and thus cannot restore abdominal wall dynamic function.21,22 With the availability of biological materials, surgeons increasingly are using these materials for effective surgical management of abdominal incisional hernia.23–25 Porcine small intestinal submucosa (SIS) (Surgisis; Cook Biotech, West Lafayette, IN) is a biological material that is harvested and processed such that its molecular matrix remains intact, to serve as a scaffold for host tissue repair and remodeling. SIS responds to site-specific stressors to induce host tissue proliferation along its scaffold, leading to structured regeneration of host tissue. In experimental and other studies, SIS induced angiogenesis and wound repair and provided a biological barrier to bacterial invasion.26 –32 We conducted the study reported in this article to examine the feasibility and efficacy of repairing large abdominal hernias using relaxing incisions, as first described by Gibson,33 and an onlay of SIS to achieve primary closure with low to no tension on the midline.
We recorded and analyzed surgical time, intraoperative blood loss, complications, and length of hospital stay. Main outcome measures were postoperative complications and hernia recurrence.
Patients and Methods We retrospectively reviewed the records of all patients who underwent an elective repair of a large (⬎6 cm in diameter) incisional hernia using our novel surgical technique with an onlay of SIS between January 2002 and December 2008, at 2 hospitals. Computed tomography (CT) scans of the abdomen and pelvis were performed preoperatively on all patients to assess the number, location, and size of defects and the extent of lateral shift in muscles from their positions at rest to their positions under stress (Valsalva maneuver). Comorbid conditions such as diabetes, cardiac disease, and chronic obstructive pulmonary disease were assessed and managed preoperatively and patients were medically cleared for surgery. Bowel preparation consisted of tap water enemas until clear the day before surgery. Antibiotic prophylaxis consisted of erythromycin and neomycin (3 oral 1-g doses of each) the day before surgery and a single dose of antibiotic administered intravenously 1 hour before the scheduled incision time. Deep vein thrombosis prophylaxis consisted of subcutaneous injection of 5,000 IU heparin 2 hours before the scheduled incision time and application of a sequential compression device to the patient’s legs when on the operating table. Patients also received heparin postoperatively (5,000 IU subcutaneously, every 8 hours for 3 doses). For pain relief, patients were given a narcotic analgesic intramuscularly or intravenously as necessary for the first 48 hours. After discharge, patients were followed up in the outpatient surgical clinic once a month for the first 6 months and thereafter once every 6 months. Recurrence was determined by physical examination and confirmed by abdominal CT scan.
Surgical technique The patient is placed supine on the operating table and general anesthesia is induced. A Foley catheter is inserted. The skin is prepared by swabbing with povidone-iodine (Betadine; Purdue Pharma, Stanford, CT ) solution from the nipples to the pubis and laterally to the posterior axillary line, and then the patient is draped. The old skin scar is excised. The hernia sac is identified and by blunt and sharp dissection is separated from the skin and subcutaneous tissues up to the neck of the sac at the edge of the defect. The anterior rectus abdominis sheath (ARS) is identified and by blunt and sharp dissection is separated from the subcutaneous tissue, cephalad as far as the costal margin, caudad to the level of the anterior superior iliac spine, and laterally as far as the lateral margin of the rectus muscle or the linea semilunaris of Spiegel and beyond to the external oblique muscle. The contents of the hernia sac are freed by blunt and sharp dissection from the sac and from the parietal peritoneum and are repositioned into the peritoneal cavity. The sac then is excised along the edge of the defect. Bleeding from perforator vessels is controlled by electrocautery and when necessary by ligation of the vessel using a figure-of-8, 00 absorbable suture. A relaxing incision is made on each side of the ARS, as described by Gibson,33 starting at the costal margin and extending to the level of the anterior superior iliac spine (Fig. 1). The abdominal wall defect is closed with figure-of-8 interrupted absorbable (polyglycolic acid) 00 sutures (Fig. 2). Next, a single piece of 8-ply SIS is placed onlay, over the denuded recti abdominis muscles and sutured in position. First, 4 stay stitches are placed at 3, 6, 9, and 12 o’clock, 3 to 4 cm outside the upper edge of the suture line. Then, continuous sutures are placed for the full 360° around the edge of the onlay (Fig. 3). Two Jackson-Pratt (Cardinal Health, Dublin, OH) drains are placed through stab wounds lateral and inferior to the surgical incision and anchored to the skin with 00 silk. The drains are positioned between the onlay and abdominal skin. The skin edges of the surgical incision are trimmed and then approximated and closed with staples.
Results Characteristics of the 71 patients and procedures are shown in Table 1. There were no deaths. Of the 71 patients, 37 had undergone one or more previous repairs. In 19 patients (27%), mesh had been used. In 14 patients the mesh had been placed as a sublay, and in 5 patients the mesh had been placed laparoscopically. In 7 of the 19 patients with mesh the wound was infected. We removed the mesh in all 19 cases. None of the 71 patients required pain medication
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beyond 48 hours postoperatively. The mean follow-up period was 40 months (range, 9 – 82 mo). Three (4%) of the 71 patients had a large wound hematoma that required surgical drainage. Another 3 (4%) of the 71 patients developed skin necrosis at the edge of the wound, exposing the biological material; they were treated conservatively with dressings and oral antibiotics and discharged 9 days after surgery. Three (4%) of the 71 patients developed a urinary tract infection, which was treated successfully with appropriate oral antibiotics. One (1.4%) of the 71 patients developed pneumonia postoperatively; this
Figure 2 Intraoperative photograph. Relaxing incisions were made in the ARS bilaterally (Gibson33 technique), from the costal margin to the level of the anterior superior iliac spine, and the muscle and fascia were sutured to effect primary abdominal closure in the midline (thick arrow). The lateral edges of the incised ARS have relaxed laterally (thin arrows), exposing the rectus abdominis muscles. DR ⫽ denuded rectus abdominis muscles.
was treated successfully with appropriate antibiotics and the patient was discharged 10 days after surgery. Wound seroma occurred in 51 (72%) of the 71 patients. In all cases, the seroma was suspected by physical examination and both confirmed and managed by fine-needle aspiration, with or without sonography. The median time between surgery and diagnosis of seroma was 19 days (range, 12– 42 d). The mean time to complete resolution was 52 days (range, 28 – 130 d). One (1.4%) of the 71 patients had a recurrence of the abdominal incisional hernia. The recurrence was diagnosed by physical examination at the 6-month postoperative visit and confirmed by a CT scan of the abdomen showing a midline defect measuring approximately 6 ⫻ 5 cm. The
Figure 1 Surgical technique. 1 ⫽ left rectus abdominis muscle; 2 ⫽ left external oblique muscle; 3 ⫽ left internal oblique muscle; 4 ⫽ left transversus abdominis muscle. BM ⫽ biological material. (A) Location (arrow) of relaxing incision to be created on the left side of the anterior rectus abdominis sheath. (B) Mobilization of the left anterior rectus abdominis sheath. After creation of bilateral relaxing incisions, muscle and fascia are sutured to achieve primary abdominal closure in the midline. (C) After biological material is placed over the denuded recti abdominis, it is sutured to the lateral edges of the rectus abdominis sheath.
Figure 3 Intraoperative photograph. The onlay of biological material has been sutured to the relaxed lateral edges of the ARS.
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Table 1 Characteristics of 71 patients undergoing repair of a large incisional abdominal hernia Characteristic Sex, male/female Median age, y Mean body mass index, kg/m2 (range) Number in ASA class, % I II III IV Mean size of the defect, cm2 (range) Numbers with previous repairs, % No previous repair 1 previous repair ⬎1 previous repair Mean duration of surgery, min (range) Mean intraoperative blood loss, mL (range) Time in intensive care unit, h Time on respirator, h Median days in hospital, range Median months of follow-up evaluation, range
Results 61 34 26 28 14 3 195 34 27 10
2/3 (39–86) (23–44) (37) (39) (20) (4) (150–420) (48) (38) (14)
125 (75–255) 220 (100–650) 0 0 6 (3–12) 40 (9–82)
patient refused surgery and was lost to further follow-up evaluation.
Comments The ideal for repair of abdominal incisional hernia is to reconstruct the midline with native musculoaponeurotic tissues. When the ideal is achieved, at rest the stretched fascia protects the relaxed muscle, and under stress the contracted muscle protects the relaxed fascia. Fascia is more vulnerable where protection by muscle is missing or insufficient.21 In these areas, fascia cannot resist increased intra-abdominal pressure and becomes permanently deformed (elongated and thinned),26 loss of normal architecture and normal collagen metabolism ultimately lead to tearing.20,21 When musculoaponeurotic tissues cannot be reapproximated without tension, prosthetic materials may be used as onlays or sublays or inlays to achieve primary fascial closure with minimal tension on the repair.7–10 However, inorganic prosthetic materials only restore the structure of the abdominal wall, and not its function, because inorganic materials are passive, rigid, and adynamic.21,22 Furthermore, inorganic materials are associated with foreign body complications such as extrusion, protrusion, erosion, fistula formation, and infection.17–20 With the availability of biological materials, which seem to avoid the earlier-listed problems with inorganic prostheses, we developed the technique described in this study to achieve primary repair of large midline defects without tension. The bilateral relaxing incisions in the ARS allow for cooptation of the medial edges of the rectus abdominis muscle and fascia to reconstruct the midline with low or no
tension. The relaxing incisions allow up to 6 cm of advancement toward the midline. The biological onlay sutured to the lateral edges of the ARS provides 2 mechanical and 2 biological advantages. The first mechanical advantage is that when sutured to the lateral edges of the ARS, the onlay further decreases tension on the sutured midline. The second mechanical advantage is that the onlay serves as a binder to protect the sutured midline from increased tension owing to increases in intra-abdominal pressure. These mechanical advantages last for 90 days after implantation, during which time the tensile strength of the biological material equals that of polypropylene.23,25 The first biological advantage of the onlay is that it stimulates regrowth of the fascia over the recti muscles, which were denuded because of the bilateral relaxing incisions. The second biological advantage is that the onlay stimulates production and deposition of collagen on the suture line, to accelerate wound healing. In animal studies, within 12 weeks after implantation, biological materials were filled with a regenerated tissue that grossly and histologically resembled normal fascia. Over time, the biological material becomes fully integrated with the host tissues. The angiogenic properties of the biological material allows it to serve as a barrier to bacterial invasion,28 –30 which explains why the risk of wound infection with biological materials is much lower than with inorganic prosthetic meshes, despite the biological onlay’s proximity to subcutaneous tissues.11,31,32,34 We attribute the high incidence of seroma formation in our series to the extensive dissection needed to mobilize the skin and subcutaneous tissue from the fascia and to divide and ligate perforator vessels. All of these maneuvers create a potential space in which a seroma can form. The remodeling process that the biological material undergoes also would tend to promote seroma formation. During the first 2 to 4 weeks after onlay placement of the biological material, host cells are attracted to the outer (ventral) side of the material through the built-in holes (Fig. 4) and, although this process is occurring, the outer/ventral side of the biological material is not able to adhere to the overlying subcutaneous tissues. The potential space between the onlay and subcutaneous layers will tend to fill with fluid, creating a seroma. We have been exploring whether slight modifications in our procedure might decrease seroma formation, but none has been effective. It may be that the promotion of seroma formation is inherent to the biological material. This study was limited by its retrospective design, lack of a control group, and variabilities in setting and individual physicians’ interpretations of clinical findings. Nevertheless, our findings of zero mortality and low morbidity with greater than 98% success in primary closure with no or low tension indicate that our procedure is safe and effective. The procedure adheres to principles of surgery, not only restoring the anatomy and integrity of the abdominal wall but also its function (flexibility and elasticity, allowing active contraction and passive relaxation). Furthermore, the onlay of
M. Tuveri et al.
Incisional hernias and biological materials
Figure 4 Postoperative photograph 2 to 4 weeks after onlay placement, the outer/ventral side of the biological material becomes colonized by native tissue that has migrated through holes in the onlay from the side in contact with vascularized tissue (the denuded recti muscles).
biological material promotes complete and definitive healing of the sutured midline, without the high risks of infection and other complications of inorganic materials. Further studies are required to confirm the advantages of our technique for reconstructing the midline using a biological material onlay.
References 1. Mudge M, Hughes LE. Incisional hernia: a 10-year prospective study of incidence and attitudes. Br J Surg 1985;72:70 –1. 2. Mathes SJ, Steinwald PM, Foster RD, et al. Complex abdominal wall reconstruction: a comparison of flap and mesh closure. Ann Surg 2000;232:586 –96. 3. Szczerba SR, Dumanian GA. Definitive surgical treatment of infected or exposed ventral hernia mesh. Ann Surg 2003;237:437– 41. 4. Sukkar SM, Dumanian GA, Szczerba SM, et al. Challenging abdominal wall defects. Am J Surg 2001;181:115–21. 5. Flament JB, Rives J. Major incisional hernia. In: Chevrel JP, ed. Hernias and Surgery of the Abdominal Wall. 2nd ed. Berlin: Springer; 1998. 6. Stoppa R, Ralaimaramanana F, Henry X, et al. Evolution of large ventral incisional hernia repair. The French contribution to a difficult problem. Hernia 1999;3:1–3. 7. Conze J, Krones CJ, Schumpelick V, et al. Incisional hernia: challenge of re-operations after mesh repair. Langenbecks Arch Surg 2007;392: 453–7. 8. Flum DR, Horvath K, Koepsell T. Have outcomes of incisional hernia repair improved with time? A population-based analysis. Ann Surg 2003;237:129 –35. 9. Paul A, Korenkov M, Peters S, et al. Unacceptable results of the Mayo procedure for repair of abdominal incisional hernias. Eur J Surg 1998;164:361–7. 10. Burger JW, Luijendijk RW, Hop WC, et al. Long-term follow-up of a randomized controlled trial of suture versus mesh repair of incisional hernia. Ann Surg 2004;240:578 – 83.
e11 11. Luijendijk RW, Hop WC, van den Tol MP, et al. A comparison of suture repair with mesh repair for incisional hernia. N Engl J Med 2000;343:392– 8. 12. Cassar K, Munro A. Surgical treatment of incisional hernia. Br J Surg 2002;89:534 – 45. 13. Israelsson LA, Smedberg S, Montgomery A, et al. Incisional hernia repair in Sweden 2002. Hernia 2006;10:258 – 61. 14. Korenkov M, Sauerland S, Arndt M, et al. Randomized clinical trial of suture repair, polypropylene mesh or autodermal hernioplasty for incisional hernia. Br J Surg 2002;89:50 – 6. 15. Hesselink VJ, Luijendijk RW, de Wilt JH, et al. An evaluation of risk factors in incisional hernia recurrence. Surg Gynecol Obstet 1993;176: 228 –34. 16. Kurzer M, Kark A, Selouk S, et al. Open mesh repair of incisional hernia using a sublay technique: long-term follow-up. World J Surg 2008;32:31– 6. 17. Jezupovs A, Mihelsons M. The analysis of infection after polypropylene mesh repair of abdominal wall hernia. World J Surg 2006;30: 2270 – 8. 18. Kumar S, Wilson RG, Nixon SJ, et al. Chronic pain after laparoscopic and open mesh repair of groin hernia. Br J Surg 2002;89:1476 –9. 19. Leber GE, Garb JL, Alexander AI, et al. Long-term complications associated with prosthetic repair of incisional hernias. Arch Surg 1998;133:378 – 82. 20. DuBay DA, Wang X, Adamson B, et al. Mesh incisional herniorrhaphy increases abdominal wall elastic properties: a mechanism for decreased hernia recurrences in comparison with suture repair. Surgery 2006;140:14 –24. 21. Junge K, Klinge U, Prescher A, et al. Elasticity of the anterior abdominal wall and impact for reparation of incisional hernias using mesh implantation. Hernia 2001;5:113– 8. 22. Shaikh FM, Giri SK, Durrani S, et al. Experience with porcine acellular dermal collagen implant in one-stage tension-free reconstruction of acute and chronic abdominal wall defects. World J Surg 2007;31: 1966 –72. 23. Liyanage SH, Purohit GS, Frye JN, et al. Anterior abdominal wall reconstruction with a Permacol implant. J Plast Reconstr Aesthet Surg 2006;59:553–5. 24. Helton WS, Fisichella PM, Berger R, et al. Short-term outcomes with small intestinal submucosa for ventral abdominal hernia. Arch Surg 2005;140:549 – 60. 25. DuBay DA, Choi W, Urbanchek MG, et al. Incisional herniation induces decreased abdominal wall compliance via oblique muscle atrophy and fibrosis. Ann Surg 2007;245:140 – 6. 26. Dejardin LM, Arnoczky SP, Clarke RB. Use of small intestinal submucosal implants for regeneration of large fascial defects: an experimental study in dogs. J Biomed Mater Res 1999;46:203–11. 27. Korenkov M, Paul A, Sauerland S, et al. Classification and surgical treatment of incisional hernia. Results of an experts’ meeting. Langenbecks Arch Surg 2001;386:65–73. 28. Clarke KM, Lantz GC, Salisbury SK, et al. Intestine submucosa and polypropylene mesh for abdominal wall repair in dogs. J Surg Res 1996;60:107–14. 29. Lantz GC, Badylak SF, Hiles MC, et al. Small intestinal submucosa as a vascular graft: a review. J Invest Surg 1993;6:297–310. 30. Hodde J. Naturally occurring scaffolds for soft tissue repair and regeneration. Tissue Eng 2002;8:295–308. 31. de Vries Reilingh TS, van Geldere D, Langenhorst B, et al. Repair of large midline incisional hernias with polypropylene mesh: comparison of three operative techniques. Hernia 2004;8:56 –9. 32. Sarikaya A, Record R, Wu CC, et al. Antimicrobial activity associated with extracellular matrices. Tissue Eng 2002;8:63–71. 33. Gibson CL. Operation for the cure of large ventral hernias. Ann Surg 1920;72:214B. 34. Kaafarani HM, Hur K, Hirter A, et al. Seroma in ventral incisional herniorrhaphy: incidence, predictors and out come. Am J Surg 2009; 198:639 – 44.
How I Do It
Repair of large abdominal incisional hernia by reconstructing the midline and use of an onlay of biological material Massimiliano Tuveri, M.D.a,*, Augusto Tuveri, M.D.a, Enrico Nicolò, M.D., F.A.C.S., F.I.C.S.b a
Department of General Surgery, Sant’Elena Clinic, viale Marconi 160, 09045 Quartu, Sant’Elena, Cagliari, Italy; Department of General Surgery, Jefferson Regional Medical Center, Pittsburgh, PA, USA
b
KEYWORDS: Incisional hernia; Surgical repair; Biological material; Recurrence; Midline
Abstract BACKGROUND: The aim of this study was to determine the feasibility and efficacy of repairing large abdominal incisional hernias by reconstructing the midline using bilateral abdominis rectus muscle sheath (ARS) relaxing incisions and a biological material onlay. METHODS: Between January 2002 and December 2008, 71 patients underwent repair of large incisional hernias at 2 community hospitals. After replacement of hernia sac contents into the peritoneal cavity, a relaxing incision was made in the ARS bilaterally. Then, the midline was closed primarily. The biological material was used as an onlay and sutured to the lateral edges of the relaxed ARS. Main outcome measures were postoperative complications and hernia recurrence. RESULTS: Median defect size was 195 cm2 (range, 150 – 420 cm2), median surgical time was 125 minutes, and median hospital stay was 6 days. There were no deaths and no wound infections. Wound seroma, the most frequent postoperative complication, occurred in 51 (72%) of the 71 patients. There was 1 (1.4%) recurrence. CONCLUSIONS: In these 71 patients, our technique for repair of large abdominal incisional hernias was safe and effective. © 2011 Elsevier Inc. All rights reserved.
Incisional hernia is an iatrogenic event, a consequence of surgical failure.1 Repair of an abdominal incisional hernia is complex and difficult and should be considered a major and challenging surgical procedure.2– 4 The main principle of abdominal incisional hernia repair is to restore the anatomic and physiologic integrity of the abdominal wall by reconstructing the midline.5,6 Ideally, midline structural support is restored by midline approximation of local musculoapo* Corresponding author. Tel.: ⫹39-70-371117; fax: ⫹39-70-837391. E-mail address: [email protected] Manuscript received October 8, 2009; revised manuscript June 21, 2010
0002-9610/$ - see front matter © 2011 Elsevier Inc. All rights reserved. doi:10.1016/j.amjsurg.2010.06.005
neurotic tissues (rectus muscle and fascia) with good blood and nerve supply. Approximation of native musculoaponeurotic tissue without tension on the suture line will restore the elasticity and flexibility of the abdominal wall (ie, its ability to actively contract and passively relax). Smaller defects (ⱕ6 cm in diameter) can be repaired successfully by medial advancement of the rectus abdominis muscles. However, 30% to 50% of defects larger than 6 cm recur after primary closure7–10 because the edges of the defect cannot be approximated without tension on the suture line. Insertion of an alloplastic material to decrease or eliminate tension on the suture line can reduce the incidence of recurrence to 10% or less.10 –16 However, inorganic pros-
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thetic materials have been associated with a high risk of complications such as protrusion, extrusion, infection, and intestinal fistulization.17–20 Most importantly, inorganic materials are rigid, passive, and adynamic, and thus cannot restore abdominal wall dynamic function.21,22 With the availability of biological materials, surgeons increasingly are using these materials for effective surgical management of abdominal incisional hernia.23–25 Porcine small intestinal submucosa (SIS) (Surgisis; Cook Biotech, West Lafayette, IN) is a biological material that is harvested and processed such that its molecular matrix remains intact, to serve as a scaffold for host tissue repair and remodeling. SIS responds to site-specific stressors to induce host tissue proliferation along its scaffold, leading to structured regeneration of host tissue. In experimental and other studies, SIS induced angiogenesis and wound repair and provided a biological barrier to bacterial invasion.26 –32 We conducted the study reported in this article to examine the feasibility and efficacy of repairing large abdominal hernias using relaxing incisions, as first described by Gibson,33 and an onlay of SIS to achieve primary closure with low to no tension on the midline.
We recorded and analyzed surgical time, intraoperative blood loss, complications, and length of hospital stay. Main outcome measures were postoperative complications and hernia recurrence.
Patients and Methods We retrospectively reviewed the records of all patients who underwent an elective repair of a large (⬎6 cm in diameter) incisional hernia using our novel surgical technique with an onlay of SIS between January 2002 and December 2008, at 2 hospitals. Computed tomography (CT) scans of the abdomen and pelvis were performed preoperatively on all patients to assess the number, location, and size of defects and the extent of lateral shift in muscles from their positions at rest to their positions under stress (Valsalva maneuver). Comorbid conditions such as diabetes, cardiac disease, and chronic obstructive pulmonary disease were assessed and managed preoperatively and patients were medically cleared for surgery. Bowel preparation consisted of tap water enemas until clear the day before surgery. Antibiotic prophylaxis consisted of erythromycin and neomycin (3 oral 1-g doses of each) the day before surgery and a single dose of antibiotic administered intravenously 1 hour before the scheduled incision time. Deep vein thrombosis prophylaxis consisted of subcutaneous injection of 5,000 IU heparin 2 hours before the scheduled incision time and application of a sequential compression device to the patient’s legs when on the operating table. Patients also received heparin postoperatively (5,000 IU subcutaneously, every 8 hours for 3 doses). For pain relief, patients were given a narcotic analgesic intramuscularly or intravenously as necessary for the first 48 hours. After discharge, patients were followed up in the outpatient surgical clinic once a month for the first 6 months and thereafter once every 6 months. Recurrence was determined by physical examination and confirmed by abdominal CT scan.
Surgical technique The patient is placed supine on the operating table and general anesthesia is induced. A Foley catheter is inserted. The skin is prepared by swabbing with povidone-iodine (Betadine; Purdue Pharma, Stanford, CT ) solution from the nipples to the pubis and laterally to the posterior axillary line, and then the patient is draped. The old skin scar is excised. The hernia sac is identified and by blunt and sharp dissection is separated from the skin and subcutaneous tissues up to the neck of the sac at the edge of the defect. The anterior rectus abdominis sheath (ARS) is identified and by blunt and sharp dissection is separated from the subcutaneous tissue, cephalad as far as the costal margin, caudad to the level of the anterior superior iliac spine, and laterally as far as the lateral margin of the rectus muscle or the linea semilunaris of Spiegel and beyond to the external oblique muscle. The contents of the hernia sac are freed by blunt and sharp dissection from the sac and from the parietal peritoneum and are repositioned into the peritoneal cavity. The sac then is excised along the edge of the defect. Bleeding from perforator vessels is controlled by electrocautery and when necessary by ligation of the vessel using a figure-of-8, 00 absorbable suture. A relaxing incision is made on each side of the ARS, as described by Gibson,33 starting at the costal margin and extending to the level of the anterior superior iliac spine (Fig. 1). The abdominal wall defect is closed with figure-of-8 interrupted absorbable (polyglycolic acid) 00 sutures (Fig. 2). Next, a single piece of 8-ply SIS is placed onlay, over the denuded recti abdominis muscles and sutured in position. First, 4 stay stitches are placed at 3, 6, 9, and 12 o’clock, 3 to 4 cm outside the upper edge of the suture line. Then, continuous sutures are placed for the full 360° around the edge of the onlay (Fig. 3). Two Jackson-Pratt (Cardinal Health, Dublin, OH) drains are placed through stab wounds lateral and inferior to the surgical incision and anchored to the skin with 00 silk. The drains are positioned between the onlay and abdominal skin. The skin edges of the surgical incision are trimmed and then approximated and closed with staples.
Results Characteristics of the 71 patients and procedures are shown in Table 1. There were no deaths. Of the 71 patients, 37 had undergone one or more previous repairs. In 19 patients (27%), mesh had been used. In 14 patients the mesh had been placed as a sublay, and in 5 patients the mesh had been placed laparoscopically. In 7 of the 19 patients with mesh the wound was infected. We removed the mesh in all 19 cases. None of the 71 patients required pain medication
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beyond 48 hours postoperatively. The mean follow-up period was 40 months (range, 9 – 82 mo). Three (4%) of the 71 patients had a large wound hematoma that required surgical drainage. Another 3 (4%) of the 71 patients developed skin necrosis at the edge of the wound, exposing the biological material; they were treated conservatively with dressings and oral antibiotics and discharged 9 days after surgery. Three (4%) of the 71 patients developed a urinary tract infection, which was treated successfully with appropriate oral antibiotics. One (1.4%) of the 71 patients developed pneumonia postoperatively; this
Figure 2 Intraoperative photograph. Relaxing incisions were made in the ARS bilaterally (Gibson33 technique), from the costal margin to the level of the anterior superior iliac spine, and the muscle and fascia were sutured to effect primary abdominal closure in the midline (thick arrow). The lateral edges of the incised ARS have relaxed laterally (thin arrows), exposing the rectus abdominis muscles. DR ⫽ denuded rectus abdominis muscles.
was treated successfully with appropriate antibiotics and the patient was discharged 10 days after surgery. Wound seroma occurred in 51 (72%) of the 71 patients. In all cases, the seroma was suspected by physical examination and both confirmed and managed by fine-needle aspiration, with or without sonography. The median time between surgery and diagnosis of seroma was 19 days (range, 12– 42 d). The mean time to complete resolution was 52 days (range, 28 – 130 d). One (1.4%) of the 71 patients had a recurrence of the abdominal incisional hernia. The recurrence was diagnosed by physical examination at the 6-month postoperative visit and confirmed by a CT scan of the abdomen showing a midline defect measuring approximately 6 ⫻ 5 cm. The
Figure 1 Surgical technique. 1 ⫽ left rectus abdominis muscle; 2 ⫽ left external oblique muscle; 3 ⫽ left internal oblique muscle; 4 ⫽ left transversus abdominis muscle. BM ⫽ biological material. (A) Location (arrow) of relaxing incision to be created on the left side of the anterior rectus abdominis sheath. (B) Mobilization of the left anterior rectus abdominis sheath. After creation of bilateral relaxing incisions, muscle and fascia are sutured to achieve primary abdominal closure in the midline. (C) After biological material is placed over the denuded recti abdominis, it is sutured to the lateral edges of the rectus abdominis sheath.
Figure 3 Intraoperative photograph. The onlay of biological material has been sutured to the relaxed lateral edges of the ARS.
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The American Journal of Surgery, Vol 202, No 1, July 2011
Table 1 Characteristics of 71 patients undergoing repair of a large incisional abdominal hernia Characteristic Sex, male/female Median age, y Mean body mass index, kg/m2 (range) Number in ASA class, % I II III IV Mean size of the defect, cm2 (range) Numbers with previous repairs, % No previous repair 1 previous repair ⬎1 previous repair Mean duration of surgery, min (range) Mean intraoperative blood loss, mL (range) Time in intensive care unit, h Time on respirator, h Median days in hospital, range Median months of follow-up evaluation, range
Results 61 34 26 28 14 3 195 34 27 10
2/3 (39–86) (23–44) (37) (39) (20) (4) (150–420) (48) (38) (14)
125 (75–255) 220 (100–650) 0 0 6 (3–12) 40 (9–82)
patient refused surgery and was lost to further follow-up evaluation.
Comments The ideal for repair of abdominal incisional hernia is to reconstruct the midline with native musculoaponeurotic tissues. When the ideal is achieved, at rest the stretched fascia protects the relaxed muscle, and under stress the contracted muscle protects the relaxed fascia. Fascia is more vulnerable where protection by muscle is missing or insufficient.21 In these areas, fascia cannot resist increased intra-abdominal pressure and becomes permanently deformed (elongated and thinned),26 loss of normal architecture and normal collagen metabolism ultimately lead to tearing.20,21 When musculoaponeurotic tissues cannot be reapproximated without tension, prosthetic materials may be used as onlays or sublays or inlays to achieve primary fascial closure with minimal tension on the repair.7–10 However, inorganic prosthetic materials only restore the structure of the abdominal wall, and not its function, because inorganic materials are passive, rigid, and adynamic.21,22 Furthermore, inorganic materials are associated with foreign body complications such as extrusion, protrusion, erosion, fistula formation, and infection.17–20 With the availability of biological materials, which seem to avoid the earlier-listed problems with inorganic prostheses, we developed the technique described in this study to achieve primary repair of large midline defects without tension. The bilateral relaxing incisions in the ARS allow for cooptation of the medial edges of the rectus abdominis muscle and fascia to reconstruct the midline with low or no
tension. The relaxing incisions allow up to 6 cm of advancement toward the midline. The biological onlay sutured to the lateral edges of the ARS provides 2 mechanical and 2 biological advantages. The first mechanical advantage is that when sutured to the lateral edges of the ARS, the onlay further decreases tension on the sutured midline. The second mechanical advantage is that the onlay serves as a binder to protect the sutured midline from increased tension owing to increases in intra-abdominal pressure. These mechanical advantages last for 90 days after implantation, during which time the tensile strength of the biological material equals that of polypropylene.23,25 The first biological advantage of the onlay is that it stimulates regrowth of the fascia over the recti muscles, which were denuded because of the bilateral relaxing incisions. The second biological advantage is that the onlay stimulates production and deposition of collagen on the suture line, to accelerate wound healing. In animal studies, within 12 weeks after implantation, biological materials were filled with a regenerated tissue that grossly and histologically resembled normal fascia. Over time, the biological material becomes fully integrated with the host tissues. The angiogenic properties of the biological material allows it to serve as a barrier to bacterial invasion,28 –30 which explains why the risk of wound infection with biological materials is much lower than with inorganic prosthetic meshes, despite the biological onlay’s proximity to subcutaneous tissues.11,31,32,34 We attribute the high incidence of seroma formation in our series to the extensive dissection needed to mobilize the skin and subcutaneous tissue from the fascia and to divide and ligate perforator vessels. All of these maneuvers create a potential space in which a seroma can form. The remodeling process that the biological material undergoes also would tend to promote seroma formation. During the first 2 to 4 weeks after onlay placement of the biological material, host cells are attracted to the outer (ventral) side of the material through the built-in holes (Fig. 4) and, although this process is occurring, the outer/ventral side of the biological material is not able to adhere to the overlying subcutaneous tissues. The potential space between the onlay and subcutaneous layers will tend to fill with fluid, creating a seroma. We have been exploring whether slight modifications in our procedure might decrease seroma formation, but none has been effective. It may be that the promotion of seroma formation is inherent to the biological material. This study was limited by its retrospective design, lack of a control group, and variabilities in setting and individual physicians’ interpretations of clinical findings. Nevertheless, our findings of zero mortality and low morbidity with greater than 98% success in primary closure with no or low tension indicate that our procedure is safe and effective. The procedure adheres to principles of surgery, not only restoring the anatomy and integrity of the abdominal wall but also its function (flexibility and elasticity, allowing active contraction and passive relaxation). Furthermore, the onlay of
M. Tuveri et al.
Incisional hernias and biological materials
Figure 4 Postoperative photograph 2 to 4 weeks after onlay placement, the outer/ventral side of the biological material becomes colonized by native tissue that has migrated through holes in the onlay from the side in contact with vascularized tissue (the denuded recti muscles).
biological material promotes complete and definitive healing of the sutured midline, without the high risks of infection and other complications of inorganic materials. Further studies are required to confirm the advantages of our technique for reconstructing the midline using a biological material onlay.
References 1. Mudge M, Hughes LE. Incisional hernia: a 10-year prospective study of incidence and attitudes. Br J Surg 1985;72:70 –1. 2. Mathes SJ, Steinwald PM, Foster RD, et al. Complex abdominal wall reconstruction: a comparison of flap and mesh closure. Ann Surg 2000;232:586 –96. 3. Szczerba SR, Dumanian GA. Definitive surgical treatment of infected or exposed ventral hernia mesh. Ann Surg 2003;237:437– 41. 4. Sukkar SM, Dumanian GA, Szczerba SM, et al. Challenging abdominal wall defects. Am J Surg 2001;181:115–21. 5. Flament JB, Rives J. Major incisional hernia. In: Chevrel JP, ed. Hernias and Surgery of the Abdominal Wall. 2nd ed. Berlin: Springer; 1998. 6. Stoppa R, Ralaimaramanana F, Henry X, et al. Evolution of large ventral incisional hernia repair. The French contribution to a difficult problem. Hernia 1999;3:1–3. 7. Conze J, Krones CJ, Schumpelick V, et al. Incisional hernia: challenge of re-operations after mesh repair. Langenbecks Arch Surg 2007;392: 453–7. 8. Flum DR, Horvath K, Koepsell T. Have outcomes of incisional hernia repair improved with time? A population-based analysis. Ann Surg 2003;237:129 –35. 9. Paul A, Korenkov M, Peters S, et al. Unacceptable results of the Mayo procedure for repair of abdominal incisional hernias. Eur J Surg 1998;164:361–7. 10. Burger JW, Luijendijk RW, Hop WC, et al. Long-term follow-up of a randomized controlled trial of suture versus mesh repair of incisional hernia. Ann Surg 2004;240:578 – 83.
e11 11. Luijendijk RW, Hop WC, van den Tol MP, et al. A comparison of suture repair with mesh repair for incisional hernia. N Engl J Med 2000;343:392– 8. 12. Cassar K, Munro A. Surgical treatment of incisional hernia. Br J Surg 2002;89:534 – 45. 13. Israelsson LA, Smedberg S, Montgomery A, et al. Incisional hernia repair in Sweden 2002. Hernia 2006;10:258 – 61. 14. Korenkov M, Sauerland S, Arndt M, et al. Randomized clinical trial of suture repair, polypropylene mesh or autodermal hernioplasty for incisional hernia. Br J Surg 2002;89:50 – 6. 15. Hesselink VJ, Luijendijk RW, de Wilt JH, et al. An evaluation of risk factors in incisional hernia recurrence. Surg Gynecol Obstet 1993;176: 228 –34. 16. Kurzer M, Kark A, Selouk S, et al. Open mesh repair of incisional hernia using a sublay technique: long-term follow-up. World J Surg 2008;32:31– 6. 17. Jezupovs A, Mihelsons M. The analysis of infection after polypropylene mesh repair of abdominal wall hernia. World J Surg 2006;30: 2270 – 8. 18. Kumar S, Wilson RG, Nixon SJ, et al. Chronic pain after laparoscopic and open mesh repair of groin hernia. Br J Surg 2002;89:1476 –9. 19. Leber GE, Garb JL, Alexander AI, et al. Long-term complications associated with prosthetic repair of incisional hernias. Arch Surg 1998;133:378 – 82. 20. DuBay DA, Wang X, Adamson B, et al. Mesh incisional herniorrhaphy increases abdominal wall elastic properties: a mechanism for decreased hernia recurrences in comparison with suture repair. Surgery 2006;140:14 –24. 21. Junge K, Klinge U, Prescher A, et al. Elasticity of the anterior abdominal wall and impact for reparation of incisional hernias using mesh implantation. Hernia 2001;5:113– 8. 22. Shaikh FM, Giri SK, Durrani S, et al. Experience with porcine acellular dermal collagen implant in one-stage tension-free reconstruction of acute and chronic abdominal wall defects. World J Surg 2007;31: 1966 –72. 23. Liyanage SH, Purohit GS, Frye JN, et al. Anterior abdominal wall reconstruction with a Permacol implant. J Plast Reconstr Aesthet Surg 2006;59:553–5. 24. Helton WS, Fisichella PM, Berger R, et al. Short-term outcomes with small intestinal submucosa for ventral abdominal hernia. Arch Surg 2005;140:549 – 60. 25. DuBay DA, Choi W, Urbanchek MG, et al. Incisional herniation induces decreased abdominal wall compliance via oblique muscle atrophy and fibrosis. Ann Surg 2007;245:140 – 6. 26. Dejardin LM, Arnoczky SP, Clarke RB. Use of small intestinal submucosal implants for regeneration of large fascial defects: an experimental study in dogs. J Biomed Mater Res 1999;46:203–11. 27. Korenkov M, Paul A, Sauerland S, et al. Classification and surgical treatment of incisional hernia. Results of an experts’ meeting. Langenbecks Arch Surg 2001;386:65–73. 28. Clarke KM, Lantz GC, Salisbury SK, et al. Intestine submucosa and polypropylene mesh for abdominal wall repair in dogs. J Surg Res 1996;60:107–14. 29. Lantz GC, Badylak SF, Hiles MC, et al. Small intestinal submucosa as a vascular graft: a review. J Invest Surg 1993;6:297–310. 30. Hodde J. Naturally occurring scaffolds for soft tissue repair and regeneration. Tissue Eng 2002;8:295–308. 31. de Vries Reilingh TS, van Geldere D, Langenhorst B, et al. Repair of large midline incisional hernias with polypropylene mesh: comparison of three operative techniques. Hernia 2004;8:56 –9. 32. Sarikaya A, Record R, Wu CC, et al. Antimicrobial activity associated with extracellular matrices. Tissue Eng 2002;8:63–71. 33. Gibson CL. Operation for the cure of large ventral hernias. Ann Surg 1920;72:214B. 34. Kaafarani HM, Hur K, Hirter A, et al. Seroma in ventral incisional herniorrhaphy: incidence, predictors and out come. Am J Surg 2009; 198:639 – 44.