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The enthalpies of solution of some dipeptides in aqueous urea mixtures at T = 298.15 K
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Quality of Life Following Component Separation Versus Standard Open Ventral Hernia Repair for Large Hernias David A. Klima, Victor B. Tsirline, Igor Belyansky, Kristian T. Dacey, Amy E. Lincourt, Kent W. Kercher and B. Todd Heniford SURG INNOV published online 9 July 2013 DOI: 10.1177/1553350613495113 The online version of this article can be found at: http://sri.sagepub.com/content/early/2013/07/08/1553350613495113 A more recent version of this article was published on - Apr 21, 2014
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SRIXXX10.1177/1553350613495113Surgical InnovationKlima et al
Original Article
Quality of Life Following Component Separation Versus Standard Open Ventral Hernia Repair for Large Hernias
Surgical Innovation XX(X) 1–8 © The Author(s) 2013 Reprints and permissions: sagepub.com/journalsPermissions.nav DOI: 10.1177/1553350613495113 sri.sagepub.com
David A. Klima, MD1, Victor B. Tsirline, MD1, Igor Belyansky, MD1, Kristian T. Dacey, BA1, Amy E. Lincourt, PhD1, Kent W. Kercher, MD1 and B. Todd Heniford, MD1
Abstract Introduction. Component separation (CS) has become a viable alternative to repair large ventral defects when the fascia cannot be reapproximated. However, the impact of transecting the external oblique to facilitate closure of the abdomen on quality of life (QOL) has yet to be investigated. The study goal was to investigate QOL and outcomes after standard open ventral hernia repair (OVHR) versus CS for large ventral hernias. Study design. Prospective data for all CSs were reviewed and compared with matched OVHR controls. All defects were 100 to 1000 cm2 in size and repaired with mesh. Comorbidities, complications, outcomes, and Carolinas Comfort Scale (CCS) scores, were reviewed. Results. Seventy-four CS patients were compared with 154 patients undergoing standard OVHR with similar defect sizes. Age (56.7±13.0 vs 54.7 ± 12.3 years, P = .26), defect sizes (299 ± 160 vs 304 ± 210cm2, P = .87), and BMI (32.7 ± 6.9 vs 34.2 ± 9.0 kg/m2, P = .26) were similar in both groups, respectively. There were no differences in major postoperative complications (P = .22), mesh infections (P = 1.00), wound infections (P = .07), or hernia recurrence (P = .09), but wound breakdown increased after CS (10% vs 1%, P < .001) as did seroma interventions (15% vs 4%, P = .005). Postoperative CCS scores were similar at 1 month (P = .82) and 1 year (P = .14). Conclusions. In the first comparative study of its kind, it is found that patient undergoing CS with mesh reinforcement had equal short- and long-term QOL outcomes compared with similar patients who underwent standard OVHR. Whereas wound breakdown and seroma formation are higher, the overall complication, mesh infection, and recurrence rates are similar. Keywords component separation, ventral hernia repair, quality of life, outcomes, recurrence, Carolinas Comfort Score, incisional hernia repair, mesh
Introduction Every year, 4 million laparotomies are performed in the United States.1 Fascial breakdown with hernia formation is a common complication, which leads to approximately 105 000 ventral hernia repairs (VHRs) annually.2 The 2 major predisposing factors for hernia occurrence after laparotomy are wound infection and obesity, which can increase hernia rates up to 40%.3,4 Hernia repair has evolved dramatically over the past 40 years. Previously, recurrence after primary repair was an accepted and common complication until the advent of meshes, which drastically reduced recurrences from more than 50% down to as low as 2%.1,5-8 Obesity, abdominal soft-tissue infection, staged management of the prolonged open abdomen, and suboptimal mesh selection9 has led to
larger and more complex abdominal defects, where fascial closure becomes difficult or impossible. As a result, patients with large defects or a loss of abdominal domain often receive a prosthetic bridge repair, which eliminates the gap in the abdominal wall but may result in a less functional or physiological abdominal wall. Lack of native, innervated tissue may lead to diminished mobility and can result in increased mesh sensation and impaired dynamics 1
Carolinas Medical Center, Charlotte, NC, USA
Corresponding Author: B. Todd Heniford, Carolinas Laparoscopic and Advanced Surgery Program, Division of GI and Minimally Invasive Surgery, Department of General Surgery, Carolinas Medical Center, 1000 Blythe Boulevard, MEB #601, Charlotte, NC 28203, USA. Email: [email protected]
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of the trunk while sitting, standing, bending, or performing normal activities of daily living. Biological grafts have also been utilized, but they have a high rate of recurrence resulting from mesh eventration.10-14 The value of primary fascial closure in large ventral defects and loss of abdominal domain has been extensively documented in the surgical literature.15,16 Closure of the muscular abdominal wall helps improve overall patient function and quality of life (QOL) and reduce mesh-related complications and recurrence rates.17 With large ventral hernias, reapproximation of the fascia is not feasible, and when performed, closure under great tension can lead to a prohibitively high intra-abdominal pressure. Intra-abdominal hypertension may manifest immediately as the inability to wean from mechanical ventilation after anesthesia, urinary and gastrointestinal dysfunction, and even abdominal compartment syndrome with decreased organ perfusion and impaired venous return. In the long-term, excessive fascial tension carries a high risk of hernia recurrence as a result of facial separation. Distant tissue graft transfer is timeconsuming, and outcomes are often poor. Myofascial advancement flaps or component separation (CS) was first described in 1977 by Mathes and Bostwick18 but was not popularized until 1990 by Ramirez et al.19 They demonstrated that the external oblique muscle can be separated from the internal oblique in a relatively avascular plane, and the rectus muscle with its overlying rectus fascia could be elevated from the posterior rectus sheath. This led to the notion that large abdominal wall defects can be reconstructed with functional advancement of abdominal wall components without the need for free-tissue transfer flaps. Since then, multiple studies have demonstrated that CS is a safe and effective option for the repair of large ventral hernias.20-24 Initially, CS became popular in patients with large ventral hernias and contaminated wounds. Surgeons believed that they could eliminate the need for a prosthetic mesh by achieving primary fascial closure using CS. Subsequently, CS alone was found to lead to very high recurrence rates, with studies demonstrating rates reaching 53%.9,25,26 Since then, reinforcement of the midline repair with mesh, either synthetic or biological, has gained popularity. In a clean, large VHR, rather than using the mesh as a “bridge,” CS with midline fascial closure over synthetic mesh reinforcement became fairly standard in the 18 000 CSs performed annually in the United States from 2006 to 2008.27-29 This approach not only affords improved mechanical function of the abdominal wall but importantly also provides an excellent infection barrier between the mesh and the subcutaneous tissues. Although cellulitis and superficial wound complications are common, they are often easily treated as long as the overlying fascia remains intact and the mesh
remains sterile. There is no evidence to suggest that CS has a negative impact on the fascial barrier function. With improvements in the understanding of the operative techniques for hernia repair and the use of mesh reinforcement of the abdominal wall, an overall reduction in hernia recurrence has been documented. With this, a strong recommendation has been made to eliminate recurrence as the sole marker of a successful hernia repair and to include QOL as a major outcomes measure.30-33 Despite the major physical changes required in performing a CS, including transecting muscle and the strongest fascial layer (external oblique) of the abdomen,34 important QOL issues in CS patients have not been addressed, including pain, movement, and activity limitations. Whereas studies suggest that CS patients may have persistent pain and decreased functionality postoperatively,35 no QOL studies have addressed this topic specifically or in a comparative manner. Indeed, the importance of performing a formal comparison to standard open ventral hernia repair (OVHR) to evaluate these issues, especially given the rising popularity of CS, cannot be understated. Such analysis would provide surgeons and patients with a better understanding of the appropriate use of CS, especially when weighing the risks and benefits during the decision-making and consent process. We undertook this study to evaluate the outcomes and QOL in patients with large defects undergoing non–perforator-sparing CS versus standard OVHR.
Methods After obtaining institutional review board approval, prospectively collected data from September 2005 to July 2010 were reviewed. All patients who underwent OVHR via non–perforator-sparing CS or the standard approach, with defects ranging from 100 to 1000 cm2, were examined. Patients undergoing unilateral CS, endoscopic CS, and laparoscopic VHR were excluded as were patients younger than 18 years and those with concurrent softtissue or mesh infections or enteric fistulas. Defect size was determined intraoperatively after previous mesh excision or fascial debridement to give the most accurate determination of distance to reapproximation. All patients to be included in the study consented preoperatively in the office visit prior to surgery. All data were entered via blinded data collectors who had no knowledge of the study components. Demographics of the patient population as well as defect size, previous hernia repairs, comorbidities, postoperative complications, and QOL using the Carolinas Comfort Scale (CCS) scoring system were assessed. The CCS is a well documented and proven hernia specific questionnaire for patients undergoing hernia repair with mesh. It measures pain, movement limitations, and
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Klima et al the sensation of mesh for 8 different daily activities.31,36,37 These activities include lying down, bending over, sitting up, performing activities of daily living, coughing/breathing, walking, walking upstairs, and exercising. Each question is answered on a scale of 0 to 5, with 0 = no symptoms and 5 = disabling symptoms. These answers are totaled and can range from 0 to 115 or can be averaged for each individual activity or symptom (range 0-5). It has been demonstrated to be a more effective determinant of QOL and a more patient-friendly survey than the wellestablished SF-36.37 All patients were placed in a supine position on the operating table. After induction of anesthesia, the abdomen was prepped and draped widely. A Foley bladder catheter was placed. Previous scar excision was performed, and the subcutaneous tissues were dissected with cautery to the hernia defect. After identification of the hernia, the sac was entered, and hernia contents were reduced back into the abdomen. Adhesiolysis was performed at the hernia site as well as to the abdominal wall circumferentially. A preperitoneal approach for mesh placement was performed as previously described.38 The peritoneum was dissected from the anterior abdominal wall to the bilateral paracolic gutters, to the pubis, and beyond the xiphoid. The peritoneum was then closed with a running absorbable suture to provide a barrier between the mesh and the intra-abdominal contents. A determination was made at this point concerning abdominal wall closure. If the fascia could be approximated primarily without increasing peak airway pressures to >30 mm pressure or without creating undue tension on the closure, a polypropylene mesh with at least a 7-cm defect overlap, if available, was placed in the preperitoneal space and secured using interrupted permanent transfascial sutures. For patients in whom the fascia could not be primarily reapproximated over the mesh, a CS was performed as described previously by Ramirez et al.19 After dissection of the preperitoneal space, cautery was utilized to dissect out the subcutaneous space to the midaxillary line. Cautery was also then utilized to cut the external oblique aponeurosis (Figure 1) lateral to the rectus sheath. This incision was extended as needed from the fascia just overlying the ribs, down to the level of the anterior superior iliac spine. Release of the external oblique fascia was then repeated on the opposite side. Posterior rectus sheath release was performed by incising the sheath 2.5 cm lateral to the linea alba. The posterior rectus sheath was incised from the xiphoid to the arcuate line and repeated on the opposite side. The mesh was inserted as previously described, with the intent to place it lateral to the cut edge of the external oblique. The mesh was secured using transfascial monofilament nonabsorbable sutures. All patients received a lightweight polypropylene mesh, with or without antiadhesive coating: UltraPro or Proceed
Figure 1. Intraoperative photographs of component separation.
Figure 2. Preoperative and postoperative photographs of a patient undergoing component separation: before (left) and after (right).
(Ethicon Inc) and Bard Soft or Ventralight ST (C. R. Bard, Cranston, RI). Drains were then placed over the mesh while the anterior fascia was closed with a running, long-acting absorbable suture over the prosthetic with a long stitch technique. This, in effect, isolated the mesh from the subcutaneous space. The subcutaneous tissues were thoroughly irrigated. In most cases, 1 or 2 subcutaneous drains were placed over the fascia depending on the extent of subcutaneous dissection. The subcutaneous tissues were then closed with an interrupted dissolvable suture and the skin was closed using an absorbable subcuticular stitch or staples (Figure 2). Patients who underwent CS were matched to 154 patients with standard OVHR who had defect sizes from 100 to 1000 cm2. Standard statistical procedures were carried out for defect size, age, and BMI, and a 2-tailed t test was performed and confirmed similarity between groups. All subsequent data underwent standard statistical analysis. For data measured on the interval scale, the Student’s t test was used. If the data were ordinal or not normally distributed, the Wilcoxon rank sum test was
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Table 1. Demographics.
Age (years) Sex (male) ASA score BMI (kg/m2) Defect size (cm2) Prior hernia repairs Prior number of hernia repairs Prior mesh used
Table 2. Complications Comparing CS Versus OVHR. CS (n = 74)
OVHR (n = 154)
P Value
56.5 ± 13.0 34 (46%) 2.5 ± 0.6 32.8 ± 7.0 299 ± 161 44 (60%) 1.6 ± 1.9 40 (54%)
54.8 ± 12.3 59 (38%) 2.5 ± 0.6 34.2 ± 9.0 301 ± 206 102 (66%) 1.2 ± 1.7 83 (54%)
.35 .31 .52 .23 .95 .38 .20 1.00
Abbreviations: CS, component separation; OVHR, open ventral hernia repair; ASA, American Society of Anesthesiology
used. For nominal data, the χ2 or Fisher’s exact test was used. A 2-tailed P value of less than .05 was considered statistically significant.
CS (n = 74) OVHR (n = 154) P Value Hospital LOS (days) Death Major complications Respiratory failure Myocardial infarct Renal dysfunction Pulmonary embolism Seroma intervention Wound breakdown Wound infections Mesh infections 30-Day readmission Hernia recurrence
8.2 ± 7.1 1 (1.4%) 7 (9.5%) 2 (2.7%) 0 (0%) 1 (1.4%) 3 (4.1%) 11 (14.9%) 8 (10.8%) 10 (13.5%) 0 (0%) 5 (6.8%) 3 (4.1%)
8.8 ± 11.8 1 (0.7%) 22 (14.3%) 8 (5.2%) 0 (0%) 9 (5.8%) 2 (1.3%) 6 (3.9%) 1 (0.7%) 9 (5.8%) 2 (1.3%) 6 (3.9%) 2 (1.3%)
.69 .10 .22 .51 1.00 .17 .33 .005 <.001 .07 1.00 .34 .09
Abbreviations: CS, component separation; OVHR, open ventral hernia repair; LOS, length of stay. Major complications include death, respiratory Failure, myocardial infarct, renal dysfunction, and pulmonary embolism.
Results Demographics A total of 74 patients undergoing CS met inclusion criteria for analysis and were matched to 154 patients undergoing standard OVHR. Demographics are listed in Table 1. Our patients were more commonly female in each group (54.1% vs 61.7%, P = .31) with similar age (56.5 ± 13.0 vs 54.8 ± 12.3 years, P = .35) and BMI (32.8 ± 7.0 vs 34.2 ± 9.0 kg/m2) in the CS and OVHR groups, respectively. Hernia defects were of similar size (299 ± 161 vs 301 ± 206 cm2, P = .95). Approximately 60% of procedures were performed on recurrent hernias (59.5% vs 66.2%, P = .38), with the average patient having 2.36 ± 1.93 versus 2.09 ± 1.70 (P = .40) previous repairs, respectively, and a majority of these still had the mesh in place (54.1% vs 53.9%, P = 1.00). American Society of Anesthesiology (ASA) class was similar as well (2.5 ± 0.6 vs 2.5 ± 0.6, P = .52).
Complications Mean hospital length of stay was 8.2 ± 7.1 and 8.8 ± 11.8 days (Table 2) in the CS group and OVHR groups, respectively (P = .69). Wound complications were the most common complications and were seen more frequently in the CS group. Interventions for seroma formation were the most common wound complication, with 14.9% in the CS group versus only 3.9% in the OVHR group (P = .005). Also, 8 CS patients (10.8%) developed some wound breakdown (defined as simple skin dehiscence) versus only 1 patient with standard repair (0.7%). Wound infections and hernia recurrences were similar between groups. We found that 12 major complications were seen in 7 patients (9.5%) with CS versus 25 major complications in 22 patients (14.3%) with OVHR (P = .22). The most common major complication in the OVHR group was acute renal dysfunction (n = 9, 5.8%) and respiratory
failure (n = 8, 5.2%), all of which resolved, whereas patients with CS most commonly experienced a pulmonary embolism (n = 3, 4.1%). One patient in the CS group developed a mesh infection versus 2 in the OVHR group (P = 1.0), and there were no statistical differences between groups for any major complication.
CS Pain and QOL Statistics Immediate postoperative analgesia requirements (Table 3) were 172 ± 123 versus 179 ± 167 morphine equivalents, respectively (P = .78), with similar modes of narcotic administration. CCS symptom scores were compared for pain, movement limitation, and overall QOL (Table 4). At short-term follow-up (3-4 weeks), all 3 scores were statistically similar to preoperative scores, with overall QOL scores of 2.62 ± 1.25 preoperatively versus 2.62 ± 0.88 by 1 month (P = 1.00). At long-term follow-up (average of 10.5 months; range = 7 months to 1 year), pain (preoperative, 2.59 ± 1.25 vs postoperative, 1.59 ± 0.78; P = .003), movement limitations (preoperative, 2.71 ± 1.27 vs postoperative, 1.82 ± 1.10; P = .02), and overall QOL scores (preoperative, 2.62 ± 1.25 vs postoperative, 1.71 ± 0.68; P = .002) had significantly improved.
CS Comparisons With Standard Hernia Repair Paired analyses of postoperative CCS symptom scores were similar between the 2 groups (Table 5). Mesh sensation, pain, and movement limitations were all statistically similar between groups at both short-term and long-term follow-up. Overall QOL scores at short-term follow-up were 2.72 ± 0.86 versus 2.70 ± 1.01 (P = .82). These
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Klima et al Table 3. In-Hospital Pain Management.
Epidural PCA pump Morphine equivalents
CS (n = 74)
OVHR (n = 154)
P Value
6 (8.2%) 55 (74.3%) 172.3 ± 123.3
13 (8.3%) 113 (73.4%) 178.5 ± 166.7
1.00 .23 .78
Abbreviations: CS, component separation; OVHR, open ventral hernia repair; PCA, patient-controlled analgesia.
Table 4. Component Separation QOL Preoperatively Versus at Follow-up at Short Term and Long Term. Carolinas Comfort Score (CCS) Short term (<1 month) Pain Movement limitation Overall quality of life Long term (6-12 months) Pain Movement limitation Overall quality of life
Preoperative
Postoperative
P Value
2.59 ± 1.25 2.71 ± 1.27 2.62 ± 1.25
2.85 ± 0.88 2.92 ± 0.99 2.62 ± 0.88
.39 .48 1.00
2.59 ± 1.25 2.71 ± 1.27 2.62 ± 1.25
1.59 ± 0.78 1.82 ± 1.10 1.71 ± 0.68
.003 .02 .002
Abbreviation: QOL, quality of life.
Table 5. QOL Comparison Between CS and OVHR at Short-term and Long-term Follow-up. Carolinas Comfort Score (CCS) Short term (<1 month) Mesh sensation Pain Movement limitation Overall quality of life Long term (6-12 months) Mesh sensation Pain Movement limitation Overall quality of life
CS
OVHR
P Value
1.99 ± 0.96 2.90 ± 1.04 2.95 ± 0.99 2.72 ± 0.86
1.87 ± 1.19 3.11 ± 1.17 3.14 ± 1.12 2.70 ± 1.01
.67 .44 .47 .82
1.72 ± 0.51 1.64 ± 0.78 1.87 ± 1.13 1.70 ± 0.60
1.98 ± 1.31 2.18 ± 1.40 2.17 ± 1.41 2.18 ± 1.28
.42 .22 .49 .14
Abbreviations: QOL, quality of life; CS, component separation; OVHR, open ventral hernia repair.
numbers similarly improved by long-term follow-up to 1.70 ± 0.60 versus 2.18 ± 1.28, respectively (P = .14).
Discussion CS has become an increasingly more common procedure since it was popularized by Ramirez et al19 in 1990. More than 18 000 CSs are performed annually in the United States, and up until this point, gathering recurrence data has been the main focus of clinical research. Reinforcement with mesh has been established as a superior operation, significantly reducing recurrence rates as it does for standard OVHR.9,39 Previously, patients with a large defect or tension on closure were relegated to a bridging mesh, which has been demonstrated to have higher recurrence and mesh infection rates.40 Reapproximation of the rectus
muscles to the midline reduces both problems by allowing closure of the fascia over the mesh, protecting the mesh from superficial wound infections and restoring abdominal wall integrity.40 Although the consideration that abdominal muscle function is significantly improved by these techniques is worthwhile, objective evidence is lacking. Although recurrence is an obviously important outcome, it is not the only goal of a successful hernia repair. Restoring function and integrity, preserving the vasculature and innervation, providing stable skin and soft tissue coverage, and improving overall QOL are just as important.33,41,42 CS should not be undertaken unless absolutely required, given that the subcutaneous dissection required in a majority of cases carries an increased risk of wound complications. This likely results in increased discomfort and obviously affects abdominal wall function, but to what extent is not known. Indeed, despite the enthusiasm for CS, the actual influence of this technique on patient QOL has not been studied objectively and reported in the literature. Concerns about movement limitations and postoperative pain and their effect on QOL are valid for any surgical procedure but especially pertinent in the case of CS where normal musculature is compromised to achieve the goal of rectus reapproximation. Subjective questionnaires have been used to gauge a patient’s relative happiness with a surgery; though helpful, they do not give surgeons quantitative data about functional and QOL impact using a validated metric that can be applied to subsequent surgical decision making. The CCS is a hernia-specific QOL scoring system that has quickly become a widely accepted alternative to the generalized subjective questionnaires.31,37,43 It was developed to allow comparison of preoperative and postoperative outcomes and to compare the outcomes of different hernia repair procedures. CCS has been shown to demonstrate reproducibility, is preferred by patients, and has shown improved hernia QOL specificity when compared with the well-established SF-36.37 It appears to have gained worldwide acceptance as the predominant QOL survey for hernia repair. Currently, it has been translated into 32 languages and is being used in 42 countries. The CCS provides the surgeon with a more objective assessment of subjective complaints such as pain, movement limitations, and mesh sensation. In this study, the demographics and hernia-related factors of two patient populations were matched to reduce the possible impact on study outcomes by these factors. Important demographics,25 such as BMI, gender, age, and number of repairs were similar among groups. Given the focus of this study, defect size was a major consideration in the group comparison. To qualify, hernias needed to measure at least 100 cm2. If the abdominal wall could be closed without significant tension, a primary closure
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over a preperitoneal mesh was performed. In those in whom the abdominal wall could not be closed without marked tension, a standard components separation was performed over a mesh placed in a preperitoneal location. Overall, in-hospital major complication rates were similar between the two groups. Considering the effects of increased intra-abdominal pressure and its real possibility when repairing large hernias, pulmonary consequences and renal function were of particular interest in this study. The data demonstrated that there was no difference in abdominal pressure–related complications. The incidence of renal and pulmonary failure and pulmonary embolism were the same in both the CS and OVHR groups. As expected, the extensive subcutaneous dissection required when performing a CS led to a significantly higher incidence of wound breakdown and seroma formation as compared with a standard OVHR. In the past, these complications and their unknown consequences on patient QOL have been the major arguments to avoid performing a CS during a VHR. Wound and mesh infection rates were not significantly different, but wound infections trended toward a higher incidence in the CS patients. The need for seroma intervention, aspiration, or drain placement was significantly increased following CS. The need for seroma intervention was 14% in these patients, which is similar to other reports of 14% to 21%.44,45 But whereas these other reports included only the operative or radiological interventions for seromas, the data in this study included bedside aspirations as well. The reduction in seroma-related problems is attributed to our use of talc applied to the subcutaneous tissues of CS patients just prior to closing, which began in January of 2009. In a previously reported study, we demonstrated significantly earlier removal of drains, fewer seromas, an 8-fold decrease in seroma interventions, and significantly fewer wound infections following the use of aerosolized talc in the subcutaneous space.45 Indeed, institution of this protocol improved the outcomes of the CS group that we are now reporting. An additional option to reduce CS woundrelated complications may include endoscopic CS, which has been shown to decrease these complications while still facilitating significant advancement of the rectus muscles.24,35,46,47 QOL in CS has not previously been specifically studied, although a few studies have looked at these results in a subjective format. Shestak et al20 performed 22 CSs and suggested that “all patients reported a subjective increase in abdominal wall strength and significant improvement in the ease of performing activities of daily living.” Two patients in this group underwent quantitative assessment of truncal flexion strength, with a 40% increase in force generated. Mazzocchi et al44 had similar, but nonspecific results, with all 22 patients being “satisfied” with their
abdominal wall reconstruction, but there were no specific comments about QOL or improved function. This study demonstrates that CS, when required to repair a large hernia, improves QOL. Although, as expected, pain and movement limitations were similar to preoperative levels at 1 month, at longer follow-up, significant improvement in all categories was observed. Furthermore, this study illustrates that the patients receiving a more complex CS operation had similar improvements in QOL outcomes when compared with those patients who underwent standard OVHR. In regard to the possible impact of CS on patient QOL, including pain and movement limitations, this study documents that these concerns were unfounded. Indeed, even when we compared the acute, in-hospital narcotic requirements, CS appeared to cause no greater discomfort than standard OVHR (Table 3). This large, prospective study had some limitations; mesh properties have previously been demonstrated to have an effect on QOL as well as hernia recurrence.24,37,39 Comparison of individual mesh types was not performed; however, each operation utilized a lightweight polypropylene mesh (less than 50 g/m2). Although the follow-up at 1 year should be adequate to evaluate QOL, the data are somewhat limited in their ability to fully evaluate hernia recurrences. Whereas some previous studies have shown that a large majority of hernias in CS recur within the first 12 months,26 others have demonstrated that longer followup reveals that a number of recurrences can be missed.25
Conclusion In this first study comparing CS and standard OVHR, the analysis demonstrates that CS with mesh reinforcement in patients in whom the muscular fascia cannot be closed has equal in-hospital, short-term, and long-term QOL outcomes, including pain and movement limitations, when compared with similar patients who have undergone a standard OVHR. Although wound breakdown and seroma formation are higher, the overall complication, mesh infection, and recurrence rates are similar. Other than superficial wound-related complications, surgeons can advise their patients that performing a CS with mesh reinforcement has few drawbacks when compared with a standard open hernia repair. Authors’ Note This work was orally presented at the American Hernia Society annual meeting, 2011.
Declaration of Conflicting Interests The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
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Klima et al Funding The author(s) received no financial support for the research, authorship, and/or publication of this article.
References 1. Burger JW, Luijendijk RW, Hop WC, Halm JA, Verdaasdonk EG, Jeekel J. Long-term follow-up of a randomized controlled trial of suture versus mesh repair of incisional hernia. Ann Surg. 2004;240:578-583; discussion 583-585. 2. Rutkow IM. Demographic and socioeconomic aspects of hernia repair in the United States in 2003. Surg Clin North Am. 2003;83:1045-1051, v-vi. 3. Strzelczyk JM, Szymański D, Nowicki ME, Wilczyński W, Gaszynski T, Czupryniak L. Randomized clinical trial of postoperative hernia prophylaxis in open bariatric surgery. Br J Surg. 2006;93:1347-1350. 4. Bucknall TE, Cox PJ, Ellis H. Burst abdomen and incisional hernia: a prospective study of 1129 major laparotomies. Br Med J (Clin Res Ed). 1982;284:931-933. 5. Lomanto D, Iyer SG, Shabbir A, Cheah WK. Laparoscopic versus open ventral hernia mesh repair: a prospective study. Surg Endosc. 2006;20:1030-1035. 6. Millikan KW. Incisional hernia repair. Surg Clin North Am. 2003;83:1223-1234. 7. 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;343:392-398. 8. Heniford BT, Park A, Ramshaw BJ, Voeller G. Laparoscopic repair of ventral hernias: nine years’ experience with 850 consecutive hernias. Ann Surg. 2003;238:391-399; discussion 399-400. 9. Joels CS, Vanderveer AS, Newcomb WL, et al. Abdominal wall reconstruction after temporary abdominal closure: a ten-year review. Surg Innov. 2006;13:223-230. 10. Kingsnorth AN, Sivarajasingham N, Wong S, Butler M. Open mesh repair of incisional hernias with significant loss of domain. Ann R Coll Surg Engl. 2004;86:363-366. 11. Bluebond-Langner R, Keifa ES, Mithani S, Bochicchio GV, Scalea T, Rodriguez ED.Recurrent abdominal laxity following interpositional human acellular dermal matrix. Ann Plast Surg. 2008;60:76-80. 12. Jin J, Rosen MJ, Blatnik J, et al. Use of acellular dermal matrix for complicated ventral hernia repair: does technique affect outcomes? J Am Coll Surg. 2007;205:654-660. 13. Blatnik J, Jin J, Rosen M. Abdominal hernia repair with bridging acellular dermal matrix: an expensive hernia sac. Am J Surg. 2008;196:47-50. 14. Keller JE, Dolce CJ, Walters KC, et al. Effect of bacterial exposure on acellular human dermis in a rat ventral hernia model. J Surg Res. 2010;162:148-152. 15. Lowe JB III, Lowe JB, Baty JD, Garza JR. Risks associated with “components separation” for closure of complex abdominal wall defects. Plast Reconstr Surg. 2003;111:1276-1283; quiz 1284-1285; discussion 1286-1288. 16. Rios A, Rodriguez JM, Munitiz V, Alcaraz P, Pérez D, Parrilla P. Factors that affect recurrence after incisional herniorrhaphy with prosthetic material. Eur J Surg. 2001;167:855-859.
17. Abrahamson J, Eldar S. Abdominal incision. Lancet. 1989;1:847. 18. Mathes SJ, Bostwick J III. A rectus abdominis myocutaneous flap to reconstruct abdominal wall defects. Br J Plast Surg. 1977;30:282-283. 19. Ramirez OM, Ruas E, Dellon AL. “Components separation” method for closure of abdominal-wall defects: an anatomic and clinical study. Plast Reconstr Surg. 1990;86:519-526. 20. Shestak KC, Edington HJ, Johnson RR. The separation of anatomic components technique for the reconstruction of massive midline abdominal wall defects: anatomy, surgical technique, applications, and limitations revisited. Plast Reconstr Surg. 2000;105:731-738; quiz 739. 21. Levine JP, Karp NS. Restoration of abdominal wall integrity as a salvage procedure in difficult recurrent abdominal wall hernias using a method of wide myofascial release. Plast Reconstr Surg. 2001;107:707-716; discussion 717-718. 22. Vargo D. Component separation in the management of the difficult abdominal wall. Am J Surg. 2004;188:633-637. 23. Chang EI, Foster RD, Hansen SL, Jazayeri L, Patti MG. Autologous tissue reconstruction of ventral hernias in morbidly obese patients. Arch Surg. 2007;142:746-749; discussion 749-751. 24. Ko JH, Wang EC, Salvay DM, Paul BC, Dumanian GA. Abdominal wall reconstruction: lessons learned from 200 “components separation” procedures. Arch Surg. 2009;144:1047-1055. 25. Sailes FC, Walls J, Guelig D, et al. Synthetic and biological mesh in component separation: a 10-year single institution review. Ann Plast Surg. 2010;64:696-698. 26. 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. 27. Healthcare Cost and Utilization Project (HCUP). Calculating nationwide inpatient sample variances. http:// www.hcup-us.ahrq.gov/reports/2003_2.jsp. Accessed June 18, 2013. 28. Davison SP, Parikh PM, Jacobson JM, Iorio ML, Kalan M. A “buttressed mesh” technique for fascial closure in complex abdominal wall reconstruction. Ann Plast Surg. 2009;62:284-289. 29. Venclauskas L, Maleckas A, Kiudelis M. One-year followup after incisional hernia treatment: results of a prospective randomized study. Hernia. 2010;14:575-582. 30. Snyder CW, Graham LA, Vick CC, Gray SH, Finan KR, Hawn MT. Patient satisfaction, chronic pain, and quality of life after elective incisional hernia repair: effects of recurrence and repair technique. Hernia. 2011;15:123-129. 31. Colivita PD, Walters AL, Tsirline VB, Lincourt AE, Heniford BT. The Carolinas Comfort Score is a Reliable and Sensitive Measure of Patient Quality of Life After Mesh Hernia Repair with up to 4 Years of Follow-up. San Francisco, CA: American Hernia Society; 2011. 32. Koch A. Use of the Carolina Comfort Scale (CCS) for Evaluation of Quality of Life After Hernia Surgery With Mesh. San Francisco, CA: American College of Surgeons; 2011.
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33. Heniford BT. Quality of life: the next paradigm in hernia repair. Presidential address at: American & European Hernia Society Meeting; March 28-31, 2012; New York City, NY. 34. Skandalakis PN, Zoras O, Skandalakis JE, Mirilas P. Spigelian hernia: surgical anatomy, embryology, and technique of repair. Am Surg. 2006;72:42-48. 35. Clarke JM. Incisional hernia repair by fascial component separation: results in 128 cases and evolution of technique. Am J Surg. 2010;200:2-8. 36. Hope WW, Lincourt AE, Newcomb WL, Schmelzer TM, Kercher KW, Heniford BT. Comparing quality-of-life outcomes in symptomatic patients undergoing laparoscopic or open ventral hernia repair. J Laparoendosc Adv Surg Tech A. 2008;18:567-571. 37. Heniford BT, Walters AL, Lincourt AE, Novitsky YW, Hope WW, Kercher KW. Comparison of generic versus specific quality-of-life scales for mesh hernia repairs.J Am Coll Surg. 2008;206:638-644. 38. Novitsky YW, Porter JR, Rucho ZC, et al. Open preperitoneal retrofascial mesh repair for multiply recurrent ventral incisional hernias. J Am Coll Surg. 2006;203:283-289. 39. Ko JH, Salvay DM, Paul BC, Wang EC, Dumanian GA. Soft polypropylene mesh, but not cadaveric dermis, significantly improves outcomes in midline hernia repairs using the components separation technique. Plast Reconstr Surg. 2009;124:836-847. 40. Petersen S, Henke G, Zimmermann L, Aumann G, Hellmich G, Ludwig K. Ventral rectus fascia closure on top of mesh
hernia repair in the sublay technique. Plast Reconstr Surg. 2004;114:1754-1760. 41. Ewart CJ, Lankford AB, Gamboa MG. Successful closure of abdominal wall hernias using the components separation technique. Ann Plast Surg. 2003;50:269-273; discussion 273-274. 42. Tsirline VB, Walters, A, Klima DA, et al. Carolinas Comfort Scale™ Reappraisal using The International Hernia Mesh Registry. 2011. 43. Zaborszky A, Gyanti R, Barry JA, Saxby BK, Bhattacharya P, Hasan FA. Measurement issues when assessing quality of life outcomes for different types of hernia mesh repair. Ann R Coll Surg Engl. 2011;93:281-285. 44. Mazzocchi M, Dessy LA, Ranno R, Carlesimo B, Rubino C. “Component separation” technique and panniculectomy for repair of incisional hernia. Am J Surg. 2011;201:776-783. 45. Klima DA, Brintzenhoff RA, Tsirline VB, et al. Application of subcutaneous talc in hernia repair and wide subcutaneous dissection dramatically reduces seroma formation and postoperative wound complications. Am Surg. 2011;77: 888-894. 46. Rosen MJ, Jin J, McGee MF, Williams C, Marks J, Ponsky JL. Laparoscopic component separation in the single-stage treatment of infected abdominal wall prosthetic removal. Hernia. 2007;11:435-440. 47. Rosen MJ, Williams C, Jin J, et al. Laparoscopic versus open-component separation: a comparative analysis in a porcine model. Am J Surg. 2007;194:385-389.
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Quality of Life Following Component Separation Versus Standard Open Ventral Hernia Repair for Large Hernias David A. Klima, Victor B. Tsirline, Igor Belyansky, Kristian T. Dacey, Amy E. Lincourt, Kent W. Kercher and B. Todd Heniford SURG INNOV published online 9 July 2013 DOI: 10.1177/1553350613495113 The online version of this article can be found at: http://sri.sagepub.com/content/early/2013/07/08/1553350613495113 A more recent version of this article was published on - Apr 21, 2014
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research-article2013
SRIXXX10.1177/1553350613495113Surgical InnovationKlima et al
Original Article
Quality of Life Following Component Separation Versus Standard Open Ventral Hernia Repair for Large Hernias
Surgical Innovation XX(X) 1–8 © The Author(s) 2013 Reprints and permissions: sagepub.com/journalsPermissions.nav DOI: 10.1177/1553350613495113 sri.sagepub.com
David A. Klima, MD1, Victor B. Tsirline, MD1, Igor Belyansky, MD1, Kristian T. Dacey, BA1, Amy E. Lincourt, PhD1, Kent W. Kercher, MD1 and B. Todd Heniford, MD1
Abstract Introduction. Component separation (CS) has become a viable alternative to repair large ventral defects when the fascia cannot be reapproximated. However, the impact of transecting the external oblique to facilitate closure of the abdomen on quality of life (QOL) has yet to be investigated. The study goal was to investigate QOL and outcomes after standard open ventral hernia repair (OVHR) versus CS for large ventral hernias. Study design. Prospective data for all CSs were reviewed and compared with matched OVHR controls. All defects were 100 to 1000 cm2 in size and repaired with mesh. Comorbidities, complications, outcomes, and Carolinas Comfort Scale (CCS) scores, were reviewed. Results. Seventy-four CS patients were compared with 154 patients undergoing standard OVHR with similar defect sizes. Age (56.7±13.0 vs 54.7 ± 12.3 years, P = .26), defect sizes (299 ± 160 vs 304 ± 210cm2, P = .87), and BMI (32.7 ± 6.9 vs 34.2 ± 9.0 kg/m2, P = .26) were similar in both groups, respectively. There were no differences in major postoperative complications (P = .22), mesh infections (P = 1.00), wound infections (P = .07), or hernia recurrence (P = .09), but wound breakdown increased after CS (10% vs 1%, P < .001) as did seroma interventions (15% vs 4%, P = .005). Postoperative CCS scores were similar at 1 month (P = .82) and 1 year (P = .14). Conclusions. In the first comparative study of its kind, it is found that patient undergoing CS with mesh reinforcement had equal short- and long-term QOL outcomes compared with similar patients who underwent standard OVHR. Whereas wound breakdown and seroma formation are higher, the overall complication, mesh infection, and recurrence rates are similar. Keywords component separation, ventral hernia repair, quality of life, outcomes, recurrence, Carolinas Comfort Score, incisional hernia repair, mesh
Introduction Every year, 4 million laparotomies are performed in the United States.1 Fascial breakdown with hernia formation is a common complication, which leads to approximately 105 000 ventral hernia repairs (VHRs) annually.2 The 2 major predisposing factors for hernia occurrence after laparotomy are wound infection and obesity, which can increase hernia rates up to 40%.3,4 Hernia repair has evolved dramatically over the past 40 years. Previously, recurrence after primary repair was an accepted and common complication until the advent of meshes, which drastically reduced recurrences from more than 50% down to as low as 2%.1,5-8 Obesity, abdominal soft-tissue infection, staged management of the prolonged open abdomen, and suboptimal mesh selection9 has led to
larger and more complex abdominal defects, where fascial closure becomes difficult or impossible. As a result, patients with large defects or a loss of abdominal domain often receive a prosthetic bridge repair, which eliminates the gap in the abdominal wall but may result in a less functional or physiological abdominal wall. Lack of native, innervated tissue may lead to diminished mobility and can result in increased mesh sensation and impaired dynamics 1
Carolinas Medical Center, Charlotte, NC, USA
Corresponding Author: B. Todd Heniford, Carolinas Laparoscopic and Advanced Surgery Program, Division of GI and Minimally Invasive Surgery, Department of General Surgery, Carolinas Medical Center, 1000 Blythe Boulevard, MEB #601, Charlotte, NC 28203, USA. Email: [email protected]
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of the trunk while sitting, standing, bending, or performing normal activities of daily living. Biological grafts have also been utilized, but they have a high rate of recurrence resulting from mesh eventration.10-14 The value of primary fascial closure in large ventral defects and loss of abdominal domain has been extensively documented in the surgical literature.15,16 Closure of the muscular abdominal wall helps improve overall patient function and quality of life (QOL) and reduce mesh-related complications and recurrence rates.17 With large ventral hernias, reapproximation of the fascia is not feasible, and when performed, closure under great tension can lead to a prohibitively high intra-abdominal pressure. Intra-abdominal hypertension may manifest immediately as the inability to wean from mechanical ventilation after anesthesia, urinary and gastrointestinal dysfunction, and even abdominal compartment syndrome with decreased organ perfusion and impaired venous return. In the long-term, excessive fascial tension carries a high risk of hernia recurrence as a result of facial separation. Distant tissue graft transfer is timeconsuming, and outcomes are often poor. Myofascial advancement flaps or component separation (CS) was first described in 1977 by Mathes and Bostwick18 but was not popularized until 1990 by Ramirez et al.19 They demonstrated that the external oblique muscle can be separated from the internal oblique in a relatively avascular plane, and the rectus muscle with its overlying rectus fascia could be elevated from the posterior rectus sheath. This led to the notion that large abdominal wall defects can be reconstructed with functional advancement of abdominal wall components without the need for free-tissue transfer flaps. Since then, multiple studies have demonstrated that CS is a safe and effective option for the repair of large ventral hernias.20-24 Initially, CS became popular in patients with large ventral hernias and contaminated wounds. Surgeons believed that they could eliminate the need for a prosthetic mesh by achieving primary fascial closure using CS. Subsequently, CS alone was found to lead to very high recurrence rates, with studies demonstrating rates reaching 53%.9,25,26 Since then, reinforcement of the midline repair with mesh, either synthetic or biological, has gained popularity. In a clean, large VHR, rather than using the mesh as a “bridge,” CS with midline fascial closure over synthetic mesh reinforcement became fairly standard in the 18 000 CSs performed annually in the United States from 2006 to 2008.27-29 This approach not only affords improved mechanical function of the abdominal wall but importantly also provides an excellent infection barrier between the mesh and the subcutaneous tissues. Although cellulitis and superficial wound complications are common, they are often easily treated as long as the overlying fascia remains intact and the mesh
remains sterile. There is no evidence to suggest that CS has a negative impact on the fascial barrier function. With improvements in the understanding of the operative techniques for hernia repair and the use of mesh reinforcement of the abdominal wall, an overall reduction in hernia recurrence has been documented. With this, a strong recommendation has been made to eliminate recurrence as the sole marker of a successful hernia repair and to include QOL as a major outcomes measure.30-33 Despite the major physical changes required in performing a CS, including transecting muscle and the strongest fascial layer (external oblique) of the abdomen,34 important QOL issues in CS patients have not been addressed, including pain, movement, and activity limitations. Whereas studies suggest that CS patients may have persistent pain and decreased functionality postoperatively,35 no QOL studies have addressed this topic specifically or in a comparative manner. Indeed, the importance of performing a formal comparison to standard open ventral hernia repair (OVHR) to evaluate these issues, especially given the rising popularity of CS, cannot be understated. Such analysis would provide surgeons and patients with a better understanding of the appropriate use of CS, especially when weighing the risks and benefits during the decision-making and consent process. We undertook this study to evaluate the outcomes and QOL in patients with large defects undergoing non–perforator-sparing CS versus standard OVHR.
Methods After obtaining institutional review board approval, prospectively collected data from September 2005 to July 2010 were reviewed. All patients who underwent OVHR via non–perforator-sparing CS or the standard approach, with defects ranging from 100 to 1000 cm2, were examined. Patients undergoing unilateral CS, endoscopic CS, and laparoscopic VHR were excluded as were patients younger than 18 years and those with concurrent softtissue or mesh infections or enteric fistulas. Defect size was determined intraoperatively after previous mesh excision or fascial debridement to give the most accurate determination of distance to reapproximation. All patients to be included in the study consented preoperatively in the office visit prior to surgery. All data were entered via blinded data collectors who had no knowledge of the study components. Demographics of the patient population as well as defect size, previous hernia repairs, comorbidities, postoperative complications, and QOL using the Carolinas Comfort Scale (CCS) scoring system were assessed. The CCS is a well documented and proven hernia specific questionnaire for patients undergoing hernia repair with mesh. It measures pain, movement limitations, and
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Klima et al the sensation of mesh for 8 different daily activities.31,36,37 These activities include lying down, bending over, sitting up, performing activities of daily living, coughing/breathing, walking, walking upstairs, and exercising. Each question is answered on a scale of 0 to 5, with 0 = no symptoms and 5 = disabling symptoms. These answers are totaled and can range from 0 to 115 or can be averaged for each individual activity or symptom (range 0-5). It has been demonstrated to be a more effective determinant of QOL and a more patient-friendly survey than the wellestablished SF-36.37 All patients were placed in a supine position on the operating table. After induction of anesthesia, the abdomen was prepped and draped widely. A Foley bladder catheter was placed. Previous scar excision was performed, and the subcutaneous tissues were dissected with cautery to the hernia defect. After identification of the hernia, the sac was entered, and hernia contents were reduced back into the abdomen. Adhesiolysis was performed at the hernia site as well as to the abdominal wall circumferentially. A preperitoneal approach for mesh placement was performed as previously described.38 The peritoneum was dissected from the anterior abdominal wall to the bilateral paracolic gutters, to the pubis, and beyond the xiphoid. The peritoneum was then closed with a running absorbable suture to provide a barrier between the mesh and the intra-abdominal contents. A determination was made at this point concerning abdominal wall closure. If the fascia could be approximated primarily without increasing peak airway pressures to >30 mm pressure or without creating undue tension on the closure, a polypropylene mesh with at least a 7-cm defect overlap, if available, was placed in the preperitoneal space and secured using interrupted permanent transfascial sutures. For patients in whom the fascia could not be primarily reapproximated over the mesh, a CS was performed as described previously by Ramirez et al.19 After dissection of the preperitoneal space, cautery was utilized to dissect out the subcutaneous space to the midaxillary line. Cautery was also then utilized to cut the external oblique aponeurosis (Figure 1) lateral to the rectus sheath. This incision was extended as needed from the fascia just overlying the ribs, down to the level of the anterior superior iliac spine. Release of the external oblique fascia was then repeated on the opposite side. Posterior rectus sheath release was performed by incising the sheath 2.5 cm lateral to the linea alba. The posterior rectus sheath was incised from the xiphoid to the arcuate line and repeated on the opposite side. The mesh was inserted as previously described, with the intent to place it lateral to the cut edge of the external oblique. The mesh was secured using transfascial monofilament nonabsorbable sutures. All patients received a lightweight polypropylene mesh, with or without antiadhesive coating: UltraPro or Proceed
Figure 1. Intraoperative photographs of component separation.
Figure 2. Preoperative and postoperative photographs of a patient undergoing component separation: before (left) and after (right).
(Ethicon Inc) and Bard Soft or Ventralight ST (C. R. Bard, Cranston, RI). Drains were then placed over the mesh while the anterior fascia was closed with a running, long-acting absorbable suture over the prosthetic with a long stitch technique. This, in effect, isolated the mesh from the subcutaneous space. The subcutaneous tissues were thoroughly irrigated. In most cases, 1 or 2 subcutaneous drains were placed over the fascia depending on the extent of subcutaneous dissection. The subcutaneous tissues were then closed with an interrupted dissolvable suture and the skin was closed using an absorbable subcuticular stitch or staples (Figure 2). Patients who underwent CS were matched to 154 patients with standard OVHR who had defect sizes from 100 to 1000 cm2. Standard statistical procedures were carried out for defect size, age, and BMI, and a 2-tailed t test was performed and confirmed similarity between groups. All subsequent data underwent standard statistical analysis. For data measured on the interval scale, the Student’s t test was used. If the data were ordinal or not normally distributed, the Wilcoxon rank sum test was
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Table 1. Demographics.
Age (years) Sex (male) ASA score BMI (kg/m2) Defect size (cm2) Prior hernia repairs Prior number of hernia repairs Prior mesh used
Table 2. Complications Comparing CS Versus OVHR. CS (n = 74)
OVHR (n = 154)
P Value
56.5 ± 13.0 34 (46%) 2.5 ± 0.6 32.8 ± 7.0 299 ± 161 44 (60%) 1.6 ± 1.9 40 (54%)
54.8 ± 12.3 59 (38%) 2.5 ± 0.6 34.2 ± 9.0 301 ± 206 102 (66%) 1.2 ± 1.7 83 (54%)
.35 .31 .52 .23 .95 .38 .20 1.00
Abbreviations: CS, component separation; OVHR, open ventral hernia repair; ASA, American Society of Anesthesiology
used. For nominal data, the χ2 or Fisher’s exact test was used. A 2-tailed P value of less than .05 was considered statistically significant.
CS (n = 74) OVHR (n = 154) P Value Hospital LOS (days) Death Major complications Respiratory failure Myocardial infarct Renal dysfunction Pulmonary embolism Seroma intervention Wound breakdown Wound infections Mesh infections 30-Day readmission Hernia recurrence
8.2 ± 7.1 1 (1.4%) 7 (9.5%) 2 (2.7%) 0 (0%) 1 (1.4%) 3 (4.1%) 11 (14.9%) 8 (10.8%) 10 (13.5%) 0 (0%) 5 (6.8%) 3 (4.1%)
8.8 ± 11.8 1 (0.7%) 22 (14.3%) 8 (5.2%) 0 (0%) 9 (5.8%) 2 (1.3%) 6 (3.9%) 1 (0.7%) 9 (5.8%) 2 (1.3%) 6 (3.9%) 2 (1.3%)
.69 .10 .22 .51 1.00 .17 .33 .005 <.001 .07 1.00 .34 .09
Abbreviations: CS, component separation; OVHR, open ventral hernia repair; LOS, length of stay. Major complications include death, respiratory Failure, myocardial infarct, renal dysfunction, and pulmonary embolism.
Results Demographics A total of 74 patients undergoing CS met inclusion criteria for analysis and were matched to 154 patients undergoing standard OVHR. Demographics are listed in Table 1. Our patients were more commonly female in each group (54.1% vs 61.7%, P = .31) with similar age (56.5 ± 13.0 vs 54.8 ± 12.3 years, P = .35) and BMI (32.8 ± 7.0 vs 34.2 ± 9.0 kg/m2) in the CS and OVHR groups, respectively. Hernia defects were of similar size (299 ± 161 vs 301 ± 206 cm2, P = .95). Approximately 60% of procedures were performed on recurrent hernias (59.5% vs 66.2%, P = .38), with the average patient having 2.36 ± 1.93 versus 2.09 ± 1.70 (P = .40) previous repairs, respectively, and a majority of these still had the mesh in place (54.1% vs 53.9%, P = 1.00). American Society of Anesthesiology (ASA) class was similar as well (2.5 ± 0.6 vs 2.5 ± 0.6, P = .52).
Complications Mean hospital length of stay was 8.2 ± 7.1 and 8.8 ± 11.8 days (Table 2) in the CS group and OVHR groups, respectively (P = .69). Wound complications were the most common complications and were seen more frequently in the CS group. Interventions for seroma formation were the most common wound complication, with 14.9% in the CS group versus only 3.9% in the OVHR group (P = .005). Also, 8 CS patients (10.8%) developed some wound breakdown (defined as simple skin dehiscence) versus only 1 patient with standard repair (0.7%). Wound infections and hernia recurrences were similar between groups. We found that 12 major complications were seen in 7 patients (9.5%) with CS versus 25 major complications in 22 patients (14.3%) with OVHR (P = .22). The most common major complication in the OVHR group was acute renal dysfunction (n = 9, 5.8%) and respiratory
failure (n = 8, 5.2%), all of which resolved, whereas patients with CS most commonly experienced a pulmonary embolism (n = 3, 4.1%). One patient in the CS group developed a mesh infection versus 2 in the OVHR group (P = 1.0), and there were no statistical differences between groups for any major complication.
CS Pain and QOL Statistics Immediate postoperative analgesia requirements (Table 3) were 172 ± 123 versus 179 ± 167 morphine equivalents, respectively (P = .78), with similar modes of narcotic administration. CCS symptom scores were compared for pain, movement limitation, and overall QOL (Table 4). At short-term follow-up (3-4 weeks), all 3 scores were statistically similar to preoperative scores, with overall QOL scores of 2.62 ± 1.25 preoperatively versus 2.62 ± 0.88 by 1 month (P = 1.00). At long-term follow-up (average of 10.5 months; range = 7 months to 1 year), pain (preoperative, 2.59 ± 1.25 vs postoperative, 1.59 ± 0.78; P = .003), movement limitations (preoperative, 2.71 ± 1.27 vs postoperative, 1.82 ± 1.10; P = .02), and overall QOL scores (preoperative, 2.62 ± 1.25 vs postoperative, 1.71 ± 0.68; P = .002) had significantly improved.
CS Comparisons With Standard Hernia Repair Paired analyses of postoperative CCS symptom scores were similar between the 2 groups (Table 5). Mesh sensation, pain, and movement limitations were all statistically similar between groups at both short-term and long-term follow-up. Overall QOL scores at short-term follow-up were 2.72 ± 0.86 versus 2.70 ± 1.01 (P = .82). These
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Klima et al Table 3. In-Hospital Pain Management.
Epidural PCA pump Morphine equivalents
CS (n = 74)
OVHR (n = 154)
P Value
6 (8.2%) 55 (74.3%) 172.3 ± 123.3
13 (8.3%) 113 (73.4%) 178.5 ± 166.7
1.00 .23 .78
Abbreviations: CS, component separation; OVHR, open ventral hernia repair; PCA, patient-controlled analgesia.
Table 4. Component Separation QOL Preoperatively Versus at Follow-up at Short Term and Long Term. Carolinas Comfort Score (CCS) Short term (<1 month) Pain Movement limitation Overall quality of life Long term (6-12 months) Pain Movement limitation Overall quality of life
Preoperative
Postoperative
P Value
2.59 ± 1.25 2.71 ± 1.27 2.62 ± 1.25
2.85 ± 0.88 2.92 ± 0.99 2.62 ± 0.88
.39 .48 1.00
2.59 ± 1.25 2.71 ± 1.27 2.62 ± 1.25
1.59 ± 0.78 1.82 ± 1.10 1.71 ± 0.68
.003 .02 .002
Abbreviation: QOL, quality of life.
Table 5. QOL Comparison Between CS and OVHR at Short-term and Long-term Follow-up. Carolinas Comfort Score (CCS) Short term (<1 month) Mesh sensation Pain Movement limitation Overall quality of life Long term (6-12 months) Mesh sensation Pain Movement limitation Overall quality of life
CS
OVHR
P Value
1.99 ± 0.96 2.90 ± 1.04 2.95 ± 0.99 2.72 ± 0.86
1.87 ± 1.19 3.11 ± 1.17 3.14 ± 1.12 2.70 ± 1.01
.67 .44 .47 .82
1.72 ± 0.51 1.64 ± 0.78 1.87 ± 1.13 1.70 ± 0.60
1.98 ± 1.31 2.18 ± 1.40 2.17 ± 1.41 2.18 ± 1.28
.42 .22 .49 .14
Abbreviations: QOL, quality of life; CS, component separation; OVHR, open ventral hernia repair.
numbers similarly improved by long-term follow-up to 1.70 ± 0.60 versus 2.18 ± 1.28, respectively (P = .14).
Discussion CS has become an increasingly more common procedure since it was popularized by Ramirez et al19 in 1990. More than 18 000 CSs are performed annually in the United States, and up until this point, gathering recurrence data has been the main focus of clinical research. Reinforcement with mesh has been established as a superior operation, significantly reducing recurrence rates as it does for standard OVHR.9,39 Previously, patients with a large defect or tension on closure were relegated to a bridging mesh, which has been demonstrated to have higher recurrence and mesh infection rates.40 Reapproximation of the rectus
muscles to the midline reduces both problems by allowing closure of the fascia over the mesh, protecting the mesh from superficial wound infections and restoring abdominal wall integrity.40 Although the consideration that abdominal muscle function is significantly improved by these techniques is worthwhile, objective evidence is lacking. Although recurrence is an obviously important outcome, it is not the only goal of a successful hernia repair. Restoring function and integrity, preserving the vasculature and innervation, providing stable skin and soft tissue coverage, and improving overall QOL are just as important.33,41,42 CS should not be undertaken unless absolutely required, given that the subcutaneous dissection required in a majority of cases carries an increased risk of wound complications. This likely results in increased discomfort and obviously affects abdominal wall function, but to what extent is not known. Indeed, despite the enthusiasm for CS, the actual influence of this technique on patient QOL has not been studied objectively and reported in the literature. Concerns about movement limitations and postoperative pain and their effect on QOL are valid for any surgical procedure but especially pertinent in the case of CS where normal musculature is compromised to achieve the goal of rectus reapproximation. Subjective questionnaires have been used to gauge a patient’s relative happiness with a surgery; though helpful, they do not give surgeons quantitative data about functional and QOL impact using a validated metric that can be applied to subsequent surgical decision making. The CCS is a hernia-specific QOL scoring system that has quickly become a widely accepted alternative to the generalized subjective questionnaires.31,37,43 It was developed to allow comparison of preoperative and postoperative outcomes and to compare the outcomes of different hernia repair procedures. CCS has been shown to demonstrate reproducibility, is preferred by patients, and has shown improved hernia QOL specificity when compared with the well-established SF-36.37 It appears to have gained worldwide acceptance as the predominant QOL survey for hernia repair. Currently, it has been translated into 32 languages and is being used in 42 countries. The CCS provides the surgeon with a more objective assessment of subjective complaints such as pain, movement limitations, and mesh sensation. In this study, the demographics and hernia-related factors of two patient populations were matched to reduce the possible impact on study outcomes by these factors. Important demographics,25 such as BMI, gender, age, and number of repairs were similar among groups. Given the focus of this study, defect size was a major consideration in the group comparison. To qualify, hernias needed to measure at least 100 cm2. If the abdominal wall could be closed without significant tension, a primary closure
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over a preperitoneal mesh was performed. In those in whom the abdominal wall could not be closed without marked tension, a standard components separation was performed over a mesh placed in a preperitoneal location. Overall, in-hospital major complication rates were similar between the two groups. Considering the effects of increased intra-abdominal pressure and its real possibility when repairing large hernias, pulmonary consequences and renal function were of particular interest in this study. The data demonstrated that there was no difference in abdominal pressure–related complications. The incidence of renal and pulmonary failure and pulmonary embolism were the same in both the CS and OVHR groups. As expected, the extensive subcutaneous dissection required when performing a CS led to a significantly higher incidence of wound breakdown and seroma formation as compared with a standard OVHR. In the past, these complications and their unknown consequences on patient QOL have been the major arguments to avoid performing a CS during a VHR. Wound and mesh infection rates were not significantly different, but wound infections trended toward a higher incidence in the CS patients. The need for seroma intervention, aspiration, or drain placement was significantly increased following CS. The need for seroma intervention was 14% in these patients, which is similar to other reports of 14% to 21%.44,45 But whereas these other reports included only the operative or radiological interventions for seromas, the data in this study included bedside aspirations as well. The reduction in seroma-related problems is attributed to our use of talc applied to the subcutaneous tissues of CS patients just prior to closing, which began in January of 2009. In a previously reported study, we demonstrated significantly earlier removal of drains, fewer seromas, an 8-fold decrease in seroma interventions, and significantly fewer wound infections following the use of aerosolized talc in the subcutaneous space.45 Indeed, institution of this protocol improved the outcomes of the CS group that we are now reporting. An additional option to reduce CS woundrelated complications may include endoscopic CS, which has been shown to decrease these complications while still facilitating significant advancement of the rectus muscles.24,35,46,47 QOL in CS has not previously been specifically studied, although a few studies have looked at these results in a subjective format. Shestak et al20 performed 22 CSs and suggested that “all patients reported a subjective increase in abdominal wall strength and significant improvement in the ease of performing activities of daily living.” Two patients in this group underwent quantitative assessment of truncal flexion strength, with a 40% increase in force generated. Mazzocchi et al44 had similar, but nonspecific results, with all 22 patients being “satisfied” with their
abdominal wall reconstruction, but there were no specific comments about QOL or improved function. This study demonstrates that CS, when required to repair a large hernia, improves QOL. Although, as expected, pain and movement limitations were similar to preoperative levels at 1 month, at longer follow-up, significant improvement in all categories was observed. Furthermore, this study illustrates that the patients receiving a more complex CS operation had similar improvements in QOL outcomes when compared with those patients who underwent standard OVHR. In regard to the possible impact of CS on patient QOL, including pain and movement limitations, this study documents that these concerns were unfounded. Indeed, even when we compared the acute, in-hospital narcotic requirements, CS appeared to cause no greater discomfort than standard OVHR (Table 3). This large, prospective study had some limitations; mesh properties have previously been demonstrated to have an effect on QOL as well as hernia recurrence.24,37,39 Comparison of individual mesh types was not performed; however, each operation utilized a lightweight polypropylene mesh (less than 50 g/m2). Although the follow-up at 1 year should be adequate to evaluate QOL, the data are somewhat limited in their ability to fully evaluate hernia recurrences. Whereas some previous studies have shown that a large majority of hernias in CS recur within the first 12 months,26 others have demonstrated that longer followup reveals that a number of recurrences can be missed.25
Conclusion In this first study comparing CS and standard OVHR, the analysis demonstrates that CS with mesh reinforcement in patients in whom the muscular fascia cannot be closed has equal in-hospital, short-term, and long-term QOL outcomes, including pain and movement limitations, when compared with similar patients who have undergone a standard OVHR. Although wound breakdown and seroma formation are higher, the overall complication, mesh infection, and recurrence rates are similar. Other than superficial wound-related complications, surgeons can advise their patients that performing a CS with mesh reinforcement has few drawbacks when compared with a standard open hernia repair. Authors’ Note This work was orally presented at the American Hernia Society annual meeting, 2011.
Declaration of Conflicting Interests The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
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Klima et al Funding The author(s) received no financial support for the research, authorship, and/or publication of this article.
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