The American Journal of Surgery 215 (2018) 719e726
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Review
Component separation technique for giant incisional hernia: A systematic review Bram Cornette a, *, Dirk De Bacquer b, Frederik Berrevoet a a b
Department of General, Hepatobiliary Surgery and Liver Transplantation, Ghent University Hospital, De Pintelaan 185, 9000, Ghent, Belgium Department of Public Health, Ghent University, De Pintelaan 185, 9000, Ghent, Belgium
a r t i c l e i n f o
a b s t r a c t
Article history: Received 16 May 2017 Received in revised form 19 July 2017 Accepted 26 July 2017
The component separation technique (CST) has gained popularity among general surgeons in the management of giant abdominal hernia. A systematic review of the MedLine and EMBASE databases was performed. 36 observational cohort studies were included for data-analysis and divided in 4 main groups: Open Anterior Approach (OAA), Transversus Abdominis Release (TAR), Laparoscopic Anterior Approach (LAA) and Perforator Preserving Approach (PPA). Surgical Site Occurrences (SSO) occurred in 21.4%, 23.7%, 20.3% and 16.0% respectively. Incidence of recurrence was 11.9% (OAA), 5.25% (TAR), 7.02% (LAA) and 6.47% (PPA) with a significant difference in the advantage of TAR over OAA (p < 0.001). Limitations in this systematic review were a lack of randomized trials, a heterogenous population and non-standardized methods for measuring outcomes, all making it difficult to postulate conclusions about CST and its modifications. Based on pooled results of 36 studies, the prevalence of SSO is comparable between the techniques with an average of one in five and the prevalence of recurrences is highest when using the Open Anterior Approach at 11.9%. © 2017 Elsevier Inc. All rights reserved.
1. Introduction Incisional hernias are one of the most common complications after abdominal surgery with an estimated incidence as high as 10e50% following midline laparotomy.1,2 Hence it's not surprising that extensive research has been conducted in the prevention and management of this complication. A major improvement in hernia incidence was the development of the laparoscopic surgery where hernia incidence is on average 4.3% based on a meta-analysis of 3490 patients.2 A challenging group of patients are those who have had multiple abdominal operations or recurrent wound herniation, maximizing the stress on their abdominal wall and making subsequent repairs more difficult. The 5-year reoperative rate in 10,822 Washington state patients who underwent incisional hernia repair was 23.8% after the first reoperation, 35.3% after the second, and 38.7% after the third.3 These patients are at increased risk for hernia repair with loss of domain, hence not being able to achieve primary closure with standard procedures. Conventional methods such as primary open suture repair of ventral hernias with simple fascial
* Corresponding author. Park de Rode Poort 88, 8200, Sint-Michiels, Belgium. E-mail address:
[email protected] (B. Cornette). http://dx.doi.org/10.1016/j.amjsurg.2017.07.032 0002-9610/© 2017 Elsevier Inc. All rights reserved.
approximation results in recurrence rates in excess of 60% in longterm follow-up4,5 with the addition of mesh still resulting in longterm recurrence rates as high as 32%.5 Hernias are thus not to be overlooked and are still a burden in all surgical disciplines. To address these issues, alternative surgical approaches have been developed. This systematic review focuses on giant hernias and hernias with loss of domain which cannot be closed primarily without excessive tension and their management using the component separation technique. Due to their relative rarity there is no exact estimate of their incidence. Giant ventral hernias could be defined as ventral hernia larger than 10 cm in width with or without loss of domain.6 In 1951 Albanese et al. designed a model of component separation of the abdominal wall, later elegantly refined by Ramirez et al. in 1990 as part of a study on human cadavers.7,8 The latter's initial results showed the possibility of translating the abdominal midline on average 10 cm per side at the umbilical level when releasing the external oblique muscle, values reconfirmed in several following studies.7e9 De Vries-Reilingh et al. showed the superiority of this technique when compared to mesh only.5 Component separation has been applied increasingly and modifications trying to tackle the main issues of the technique have been made. Described limitations of this technique are complications
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Definitions and abbreviations LAA OAA PPA QoL SSO TAR
Laparoscopic/Endoscopic Anterior Approach Open Anterior Approach Perforator Preserving Approach, Open Anterior Quality of Life Surgical Site Occurrences Transversus Abdominis Release
involving the skin and subcutaneous tissue, most likely caused by surgical interruption of perforating vessels during exposure of the oblique muscle.10 To date, the more common variations on the component separation theme are the open anterior approach (OAA),8 the transversus abdominis release (TAR),11 the laparoscopic anterior approach (LAA)12 and the open anterior perforator preserving approach (PPA)13 with their original description in the noted references. This systematic review analyzes the current literature involving component separation, its most common modifications and compares these techniques to evaluate if there are important differences in reported outcomes, adding evidence for best clinical practice.
Superficial), abscess, skin necrosis, hematoma, wound dehiscence), recurrence rate (with follow-up) and quality of life (QoL). SSO had to be represented by a ratio or percentage and recurrences in the form of an incidence rate or a number/percentage and a mean (not median) follow-up period. Systemic complications and peroperative mortality were not included because of the unclear causality between the surgical technique and these complications and the latter's rarity and lack of reporting. Contamination was defined by the explicit statement of “contamination” and a percentage or ratio in the article or the sum of all percentages in the categories cleancontaminated or Grade II Hernia (as defined by Breuing et al.14) and above. We used the classification made by Muysoms et al. for mesh positioning.15 Because of the large discrepancies in study size, whenever means were calculated these were weighted for the number of patients. For both dichotomous variables (SSO, Hernia Recurrence) Pearson's Chi-Square test for an r x c table was used. When this revealed a significant result, further between group comparisons were performed using a post hoc Bonferroni correction (a ¼ 0.008). An estimated incidence rate per year was calculated with following P P formula: ( Number of recurrencesPer Study/ (Mean follow-up (year) x Number of patients)Per Study). This gave an incidence rate that was weighted for both study size and follow-up period. Analysis of data was performed using IBM SPSS Statistics 24 and Microsoft Excel. 3. Results
2. Materials & methods We performed a systematic review of the literature in the database of MedLine and EMBASE in search of articles which involved the component separation technique. Search terms used were: anterior component separation; posterior component separation; laparoscopic component separation; “components separation”; “separation of components”; “separation of parts”; external oblique release,; transverse abdominis release; abdominis muscle release; abdominal myofascial release; abdominis advancement flap; Ramirez technique. Language was limited to English, French, German or Dutch articles. The main author screened all databases on two separate occasions with a last review on 20/08/2016. This resulted in a total of 1329 records of which 36 were included after screening on basis of title and abstract (Fig. 1). To achieve the greatest level of evidence our first search was aimed at randomized controlled clinical trials but these couldn't be retrieved based on our search. Therefore we focused on pro- and retrospective cohort studies for further evidence. Included articles had to involve component separation technique, in an elective setting, in any of the four common modifications: open anterior, laparoscopic anterior, transversus abdominis release or an open anterior perforator preserving approach and report at least one of our primary outcomes. All patient groups and all ages were considered, baring special attention to children included not having repair of omphalocoele or gastroschizis. When a study described a division of an included method (e.g. uni- or bilateral approach), or division based on patient characteristics (e.g. violated vs. nonviolated rectus complex), weighted means of their outcomes were calculated. Possible contamination or hernia incarceration were no reason for exclusion. We focused on incisional and not primary abdominal wall hernias with exclusion of inguinal and femoral hernias. Parastomal hernias were also excluded. All studies involving cadavers or animals were excluded from the results, but were allowed to be used for discussion purposes. Our main primary outcomes considered were Surgical Site Occurrences (SSO) (pooled results of Surgical Site Infection (Deep/
Based on our search method and inclusion criteria 36 articles were obtained for data analysis. Of the included studies 22 concerned Open Anterior Approach (1348 cases, Fig. 2),5,10,13,16e34 8 Transversus Abdominis Release (761 cases, Fig. 3),28,35e41 13 Laparoscopic Anterior Approach (193 cases, Fig. 4)10,12,21,23e25,29,30,32,42e45 and 5 Perforator Preserving Approach (242 cases, Fig. 5).13,20,26,46,47 Study characteristics are summarized in Tables 1e4 respectively. The number of patients included in the studies ranged from [8-545] for OAA, [11-428] for TAR,4e42 for LAA and [38-65] for PPA with the median patient number being 31, 46, 11 and 41 respectively. Average defect area when weighted by study size was 279, 540, 294 and 266 cm2 based on 536, 634, 67 and 103 cases respectively. The number of contaminated procedures was 47% (252 cases) for OAA, 42% (605 cases) for TAR, 25% (146 cases) for LAA and 72% (136 cases) for the PPA group. Regarding our primary outcome Surgical Site Occurrences (SSO), there was a large range from [0.0%e82.0%] over all included studies. The OAA showed an SSO in 21.4% (283SSO/1318Cases) of cases. This was 23.7% (180SSO/761Cases) for TAR, 20.3% (39SSO/193Cases) for LAA and 16.0% (39SSO/242Cases) for the PPA. Pearson Chi-square test for these former values showed no significant result (p ¼ 0.092). When only including studies between the 25th and 75th percentile as a rough correction for outliers, the prevalence of SSO is 33.4% (OAA), 27.5% (TAR), 21.9%(LAA) and 19.0%(PPA). Regarding recurrences, pooled analysis showed a total of 79 recurrences in the OAA group based on a total patient sample of 665 (11.9%) followed for 22 months on average. In the TAR 40 recurrences for 761 cases (5.3%) were seen over a mean follow-up time of 17 months. The LAA group presented with 12 recurrences in 171 cases (7.0%) over a mean follow-up time of 11 months. In the PPA group, 13 recurrences in 201 patients (6.5%) were observed over an average 22 months of follow-up. Pearson's Chi-Square test for the pooled results of recurrence prevalence shows p < 0.001, showing a significant difference in recurrences between the 4 methods when not corrected by length of follow-up. Separate Pearson Chi-Square results are presented in Table 5.
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Fig. 1. PRISMA-chart.
Annual incidence rates of recurrence were 6.4% (17 studies), 3.8% (8 studies), 7.6% (11 studies) and 3.4% (4 studies) in the OAA, TAR, LAA and PPA groups respectively. A summary of all results can be found in Table 6. QoL was not regarded as an outcome in any of the studies retrieved by the systematic search and as such no statements about its outcomes can be made. 4. Discussion The strength of a study lies in discussing its weaknesses. Therefore the authors acknowledge there is much to be said about performing a systematic review using cohort studies when there's a paucity of randomized clinical trials in literature.48e50 As only published trials from the two largest medical databases were included, there is a risk of publication bias. We are well aware of these observations and as such want to stress that all proposed results should be interpreted with caution. We want to shortly emphasize some pitfalls in the interpretation of the results in this systematic review.
By definition, it is not possible to randomize the groups being studied in cohorts and therefore their baseline patient characteristics will be different. It is easy to see how some of these factors might be of influence on reported outcomes. Several of the included studies showed patient age,21,40 contaminated wound status40 and hernia width to be possible predictors of a Surgical Site Infection40 and obesity22,29,32,35 or previous incisional hernia repair3 as factors influencing recurrences. All these patient-related variables should be taken into account for absolute statistical validity, a rather impossible task taken into account the excessive heterogeneity in reporting between studies. Our outcomes were grouped according to the main technique of component separation being used. There are however slight modifications for the technique between studies, but its main principles remain the same and it is unclear to what extent they would influence outcomes. Further differences in surgical approach regarding mesh and closure were clustered under any of the 4 main techniques. For example mesh position and material51e53 are important factors when it comes to hernia repair and their interstudy variability is depicted in our tables. Unfortunately, because
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Fig. 2. Open anterior component separation: Primary outcomes.
Fig. 3. Transversus abdominis release: Primary outcomes.
of their heterogeneity no further sensitivity analysis could be performed. Only three outcomes were taken into consideration for this systematic review because these were subjectively considered to be the most important outcomes in hernia research. The SSO outcome is a grouped result of multiple subcategories which makes it a comprehensible but heterogenic term and a risk for bias. Good efforts have been made regarding definitions of SSO after hernia repair and the grading of hernias when presented at first.14 These are, however, not systematically applied by all studies and their predictive value remains to be thoroughly investigated further. In discussing our results it is important to highlight a number of outliers in the included studies. Sailes et al., a methodologically rather limited study, has an enormous impact in the OAA group making up almost half of the case number at a fairly low SSO rate of 8.6%.22 Taking into account the proposed outliers, heterogeneity and confounding variables all 4 surgical approaches have a prevalence of SSO of around 1/5. Would there be a correction of outliers including only studies between the 25th and 75th percentile, the occurrence of an SSO would be 33.4% (OAA), 27.5% (TAR), 21.9%(LAA) and 19.0%(PPA) showing a big impact of outliers
mostly in the OAA group. A meta-analysis of Jensen et al. included 5 studies that compared open component separation to the endoscopic variant showed significantly less wound complications in the latter's advantage, a conclusion that could not be withheld in this review containing the same studies.54 Recurrences and their assessment, yet an important factor when it comes to studies about abdominal hernias, are also vaguely described in most studies. Although the gold standard for their detection, being CT or ultrasound preferred over clinical examination only, is under discussion,55,56 it is unclear in most studies how the recurrence was identified. In our results summary, the total number of recurrences are highest in the OAA, followed by the LAA. A significant and borderline significant difference for the prevalence of recurrence was seen in the advantage of respectively TAR and PPA over OAA but is confounded by the difference in follow-up period. When adding the period of follow-up as a relative weight, where a longer follow-up is regarded more valuable than a short period, the calculated incidence rate shows the highest incidence in the LAA group (7.6%) and the lowest in the PPA group (3.4%). One major concern in this systematic review is the short mean followup period, not reaching 2 years. Long-term follow-up studies
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Fig. 4. Laparoscopic anterior component separation: Primary outcomes.
Fig. 5. Open anterior perforator preserving approach: Primary outcomes.
Table 1 Open anterior component separation: Study characteristics. Year
Study
n
Mesh Position
Mesh Material
Defect Area (cm2)
Contamination (%)
Mean FU (months)
1996 2000 2000 2002 2005 2007 2009 2010 2010 2010 2011 2011 2011 2011 2012 2012 2012 2013 2014 2015 2016 2016
DiBello et al. Shestak et al. Lowe et al. Saulis et al. Kolker et al. De Vries et al. Wind et al. Clarke et al. Harth et al. Sailes et al. Albright et al. Giurgius et al. Parker et al. Kanaan et al. Ghali et al. Krpata et al. Garvey et al. Fox et al. Azoury et al. Ng et al. Gnaneswaran et al. Hicks et al.
35 22 30 20 16 19 32 63 22 545 14 14 8 63 50 56 169 26 34 38 12 60
O e e e C No O No e O O C C e U U U U IP U O C
S(100%) S(4.5%) S(33%) e B&B (100%) No S(56%) No B(86%) S(9%) e B(100%) e S(100%) e B(100%) B(84%) S(16%) B(91.5%) S(2.4%) B(38%) S(50%) B(18%)S(82%)Both(5.8%) B(100%) B(100%) S&B (100%)
e e 240 e e e e 121 392 e e 146 e e 274 472 292 e 268 227 e 281
e e e e e e 100% e 91% e 36% 33% e e 36% e e 23% 0% e e 57%
22 52 9.5 e 16 36 e 38 16 e 4 8 7.2 38 20.7 9.1 21.3 e 10 37 14 e
O: Onlay, I: Inlay, R: Retromuscular,, P: Preperitoneal, IP: Intraperitoneal, C: Combined, S: Synthetic Mesh, B: Biologic Mesh, No: No Mesh.
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Table 2 Transversus abdominis release: Study characteristics. Year
Study
n
Mesh Position
Mesh Material
Defect Area (cm2)
Contamination (%)
Mean FU (months)
2008 2012 2013 2015 2015 2016 2016 2016
Moore et al. Krpata et al. Pauli et al. Petro et al. Petro et al. Fayezizadeh et al. Novitsky et al. Winder et al.
90 55 29 34 11 77 428 37
R R R R R R R R
S(100%) B(25%)S(75%) B(17%)S(83%) B(44%)S(56%) B(18%)S(82%) B(100%) S(100%) B(19%)S(81%)
e 531 410 431 320 306 606 e
e e 38% 62% e 92% 34% 11%
50 6.8 11 18 12 12 12 21
O: Onlay, I: Inlay, R: Retromuscular, P: Preperitoneal, IP: Intraperitoneal, C: Combined S: Synthetic Mesh, B: Biologic Mesh, No: No Mesh.
Table 3 Laparoscopic anterior component separation: Study characteristics. Year
Study
n
Mesh Position
Mesh Material
Defect Area (cm2)
Contamination (%)
Mean FU (months)
2000 2007 2009 2009 2010 2010 2011 2011 2012 2013 2014 2015 2016
Lowe et al. Rosen et al. Bachman et al. Malik et al. Cox et al. Harth et al. Albright et al. Parker et al. Giurgius et al. Fox et al. Azoury et al. Ng et al. Daes et al.
7 7 5 4 6 22 11 20 21 18 42 10 20
e IP R IP R e C C R IP IP e IP
e B(100%) B(80%) S(25%)S(75%) B(50%) S(50%) B(82%)S(18%) B(82%)S(18%) B(5%)S(90%) e B(72%)S(18%) B(26%)S(74%) B(100%) S (100%)
288 338 e 306 270 324 e e 255 e 174 103 e
e 100% 60% e e 73% 9% e 5% 44% 0% e 0%
12 4.5 6 e 10 14 4 12 8 e 8 15 21
O: Onlay, I: Inlay, R: Retromuscular, P: Preperitoneal, IP: Intraperitoneal, C: Combined, S: Synthetic Mesh, B: Biologic Mesh, No: No Mesh.
Table 4 Open anterior perforator preserving component separation: Study characteristics. Year
Study
n
Mesh Position
Mesh Material
Defect Area (cm2)
n (%)
Mean FU (months)
2002 2010 2011 2011 2012
Saulis et al. Clarke et al. Butler et al. Patel et al. Ghali et al.
41 65 38 41 57
e No I R I
e No B(100%) B(100%) B(100%)
e 132 494 e 405
e e 42% 100% 30%
e 38 12.4 15.8 15.2
O: Onlay, I: Inlay, R: Retromuscular, P: Preperitoneal, IP: Intraperitoneal, C: Combined, S: Synthetic Mesh, B: Biologic Mesh, No: No Mesh.
Table 5 Separate Chi-square test results for Recurrence.
OAA TAR LAA
TAR
LAA
PPA
p < 0.001* e e
p ¼ 0.069 p ¼ 0.365 e
p ¼ 0.029 p ¼ 0.503 p ¼ 0.833
SSO
Recurrence
Prevalence
Prevalence
Yearly incidence
21.4% 23.7% 20.3% 16.0%
11.9% (79/665) 5.3% (40/761) 7.0% (12/171) 6.5% (13/201)
6.4% 3.8% 7.6% 3.4%
*Significant value.
Table 6 Summary of results. N Studies
OAA TAR LAA PPA
22 8 13 5
(283/1318) (180/761) (39/193) (39/242)
have shown that most hernia recurrences occur in the first 2 postoperative years51,57 so the difference in follow-up period between the studies and the different techniques are a very probable confounder for the proposed results and might explain the difference in recurrence rates.
While patient reported outcomes are of increasing importance, the third outcome Quality of Life wasn't considered in any of the obtained studies.58 It is however a central factor evaluating hernia repair by giving an idea about outcomes like pain and functionality of the abdominal wall, and should be evaluated in future component separation studies.59 Baring into mind the difficulties and pitfalls mentioned above, we present the largest systematic review about the common variations of the component separation technique known to date. The authors would like to suggest that future studies would be based, at least, on the 3 outcome variables discussed above. Elegant and uniform ways of reporting outcomes in hernia repair studies are to be encouraged.60 Furthermore, as it is unknown which component separation technique should be used in what patient or hernia defect, prospective randomized controlled trials could focus more on defects between for example 10e15 cm comparing OAA versus LAA and evaluate SSO, recurrence rate and the percentages of “true augmentation” in both groups. For defects larger than 15 cm one could study TAR versus OAA with an open IPOM for the same outcomes. Follow-up for recurrences should at least last for 2 postoperative years and reporting a (half)yearly incidence rate should be stimulated as this contains information about the evolution of recurrences as follow-up progresses. Regarding QoL, both pain and functionality are important outcomes to assess. Krpata
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et al. designed a QoL-questionnaire that might prove useful in future studies.61
16.
5. Conclusion 17.
Because of the lack of appropriate randomized studies, heterogeneity in patient population, different surgical techniques, and non-standardized methods for measuring outcomes, it is difficult to postulate exact indications when to use what type of component separation technique. Based on the pooled results of 36 studies, the prevalence of SSO is comparable between the 4 techniques studied with an average of one in five patients having a complication. There is a trend towards fewer complications when using a perforator preserving approach. The calculated yearly incidence of recurrence ranges from 3.4 to 7.6% among the different techniques but its value is limited by an overall short follow-up period. Further well designed controlled randomized studies comparing the types of component separation are needed to improve patient reported outcomes after giant incisional hernia repair.
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Funding 24.
This research has been conducted without the usage of funds. No conflict of interest. 25.
Conflict of interest All authors declare that there are no financial or personal conflicts of interest. No exterior funding sources have been obtained to perform this research.
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