Accepted Manuscript

Sublay Versus Underlay in Open Ventral Hernia Repair

J.L. Holihan, I. Bondre, E.P. Askenasy, J.A. Greenberg, J. Keith, R.G. Martindale, J.S.
Roth, M.K. Liang

PII: S0022-4804(15)01186-5
DOI: 10.1016/j.jss.2015.12.014
Reference: YJSRE 13613

To appear in: Journal of Surgical Research

Received Date: 24 September 2015

Revised Date: 3 December 2015
Accepted Date: 11 December 2015

Please cite this article as: Holihan J, Bondre I, Askenasy E, Greenberg J, Keith J, Martindale R, Roth
J, Liang M, Ventral Hernia Outcomes Collaborative (VHOC) writing group, Sublay Versus Underlay in
Open Ventral Hernia Repair, Journal of Surgical Research (2016), doi: 10.1016/j.jss.2015.12.014.

This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to
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 ACCEPTED MANUSCRIPT

Sublay Versus Underlay in Open Ventral Hernia Repair

JL Holihan1, I Bondre1, EP Askenasy2, JA Greenberg3, J Keith4, RG Martindale5, JS Roth6, MK

Liang1, Ventral Hernia Outcomes Collaborative (VHOC) writing group

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Department of Surgery, University of Texas Health Science Center, Houston, Texas

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Department of Surgery, Baylor College of Medicine, Houston, Texas
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Department of Surgery, University of Wisconsin, Madison, Wisconsin
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Department of Surgery, University of Iowa, Iowa City, Iowa
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Department of Surgery, Oregon Health and Science University, Portland, Oregon
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Department of Surgery, University of Kentucky, Lexington, Kentucky
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Corresponding Author:
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Julie L. Holihan
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6431 Fannin St

MSB 5.254
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Houston, Texas 77030

Phone: 702-321-6559
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Fax: 713-566-4242
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holihanj@gmail.com

Julie.L.Holihan@uth.tmc.edu

Author Contributions

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(1) Conception and design, acquisition of data, or analysis and interpretation of data:

Holihan, Bondre, Askenasy, Greenberg, Keith, Martindale, Roth, Liang

(2) Drafting the article or revising it critically: Holihan, Bondre, Askenasy, Greenberg, Keith,

Martindale, Roth, Liang

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(3) Final approval of the version to be submitted: Liang

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Abstract

Background:

The ideal location for mesh placement in open ventral hernia repair (OVHR) remains under

debate. Current trends lean toward underlay or sublay repair. We hypothesize that in patients

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undergoing OVHR, sublay versus underlay placement of mesh results in fewer surgical site

infections (SSI) and recurrences.

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Materials and Methods:

A multi-institution database of all OVHR performed from 2010-2011 was accessed. Patients

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with mesh placed in the sublay or underlay position and at least 1 month of follow-up were

included. Primary outcome was SSI. Secondary outcome was hernia recurrence. Multivariable
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analysis was performed using logistic regression for SSI and Cox regression for recurrence.

Subgroup analysis of elective, midline ventral incisional hernias was also performed.
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Results:
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Of 447 patients, 139(31.1%) had a sublay repair. The unadjusted analysis showed no difference

in SSI and lower recurrence using sublay compared to underlay. On multivariable analysis,
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there was no difference in SSI using sublay compared to underlay (OR 1.5, 95%CI 0.8-2.8).

Recurrence was less common with sublay (HR 0.4, 95%CI 0.2-0.8). On subgroup analysis of
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elective, midline incisional hernias only (n=247), there were more SSIs with sublay compared to
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underlay repair (28.0% versus 15.1%, p=0.018); however, there was no difference in major SSI

(sublay 9.3% versus underlay 5.8%, p=0.315). There were fewer recurrences using sublay

repair compared to underlay repair (10.7% versus 25.0%, p=0.010).

Conclusions:

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In this multi-center, risk-adjusted study, sublay repair was associated with fewer recurrences

than underlay repair and no difference in SSI. Randomized controlled trials are warranted to

validate these findings.

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Introduction

Mesh reinforcement during ventral hernia repair has been demonstrated to improve long-term

outcomes compared to suture only repair.1-3 However, the ideal location for mesh is unknown.

There are multiple options for mesh placement including onlay, inlay, sublay, or underlay

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positions (figure 1). Onlay repair is when mesh is secured to the exposed anterior fascia. Inlay

repair is when mesh is placed within a defect and secured circumferentially to the edges of the

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fascia. Sublay repair is defined as either retrorectus or preperitoneal and is also commonly

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referred to as Rives-Stoppa. Finally, underlay repair is when the mesh is placed in the

intraperitoneal position and secured to the anterior abdominal wall. Current trends lean toward

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underlay or sublay placement of mesh, with onlay and inlay repairs being utilized less

frequently.4,5
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There are several theoretical benefits to both sublay and underlay repair. Proponents of sublay
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mesh placement argue that it is associated with fewer recurrences and surgical site infections
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(SSI) because the mesh is covered by native tissue on both sides: fascia and muscle anteriorly

and fascia posteriorly.6 This is theorized to protect the mesh from exposure to superficial SSIs
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and intra-peritoneal infections, prevent mesh infection by placement adjacent to well-

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vascularized tissue, and reduce hernia recurrence through tissue in-growth to two load-bearing

myofascial surfaces.6 In contrast, advocates of underlay mesh placement argue that it is

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associated with fewer recurrences due to the wide mesh overlap that can be achieved and is
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associated with less SSI compared to other techniques due to the limited tissue dissection

required.7

While both approaches have theoretical risks and benefits, there is a paucity of data comparing

outcomes of open underlay and sublay mesh ventral hernia repair. Studies suggest that there is

a reduced risk of recurrence and reoperation with sublay repair.6,8 However, these studies

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include methodologic limitations such as the inclusion of laparoscopic repairs in their underlay

cohort, combining underlay with sublay repairs, or failure to risk-adjust their results.5,9 We

hypothesize that in patients undergoing open ventral hernia repair (OVHR), sublay as opposed

to underlay placement of mesh results in fewer recurrences and SSIs.

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Materials and Methods:

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Following Institutional Review Board approval, a multi-institution retrospective study of all OVHR

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from 2010-2011 was performed. Patients with mesh placed in a sublay or underlay position and

who had at least one month of clinical follow-up were included. Sublay repair was defined as

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retromuscular or preperitoneal mesh placement while underlay repair was defined as intra-

peritoneal mesh placement.

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The primary outcome was SSI as defined by the Centers for Disease Control and Prevention
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(CDC).10 Major SSI was defined as deep and organ space SSI; this included mesh infection.
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Secondary outcome was recurrence, which was diagnosed through clinical or radiographic
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examination. Radiographic imaging, typically CT scan, was ordered only when patients

complained of symptoms potentially related to the hernia repair. All diagnoses of hernia
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recurrence were based upon clinical assessment and when needed, augmented with

radiographic assessment.
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Patient demographic data, comorbidities, hernia details, and outcomes were recorded. All

variables were defined according to the American College of Surgeons National Surgical Quality

Improvement Project or European Hernia Society guidelines and have been previously

reported.11-14

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During the study period, it was standard practice among the participating surgeons to utilize

mesh with at least 5 cm of mesh overlap when feasible (or during sublay repair from semi-lunar

line to semi-lunar line) and secure the mesh with permanent or long-acting trans-fascial sutures.

The most common synthetic mesh types utilized were low-density and mid-density

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polypropylene while the most common biologic mesh used were porcine acellular dermal matrix.

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The cohort was analyzed using two different approaches. The first approach was to assess the

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overall cohort. Categorical data was analyzed using chi square. Parametric continuous data

was analyzed using two-tailed t-test while non-parametric data was analyzed with Mann

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Whitney U. Multivariate analysis for SSI was performed using backwards stepwise logistic

regression, and a Cox regression was performed for recurrence. Variables included in the initial
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model were selected a priori and included ASA score, BMI, DM, smoking, primary versus

incisional, acute repair, wound class, fascial release, fascial closure, creation of skin flaps, mesh
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type (biologic versus synthetic), and mesh location. Variables predictive of the dependent
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variable (outcome) were reduced in a step-wise fashion. The final model was the model with
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the lowest Akaike information criterion (AIC), which is a measure of the relative quality of a

statistical model.15 A Kaplan-Meier curve of time to recurrence by repair type was created.
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The second approach was to assess more homogenous subgroups. Only elective, midline
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incisional hernias were assessed because of known limitations of sublay repair in treating lateral
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hernias and because of imbalances between groups in acute operations. These outcomes were

compared using chi-square test.

Results:

Out of 1594 patients in the multi-center database, 447 had open sublay (n=139, 31.1%) or

underlay (n=308, 68.9%) repair with at least 1 month of follow-up (figure 2). Of the patients

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excluded for less than 1 month of follow-up, 42 (16.5%) had sublay repairs and 212 (83.5%) had

underlay repairs. Compared to patients who received a sublay repair, patients who received an

underlay repair were more likely to be younger, non-white, have an incisional hernia, and

undergo an acute repair. Patients who had a sublay repair were more likely to have a fascial

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release (table 1, 2).

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There were a total of 79 (17.7%) SSIs. There was no statistical difference in the rate of SSI

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(20.9% vs 16.2%, p=0.235) or major SSI (5.8% vs 7.1%, p=0.587) between sublay and underlay

repairs (Table 3). There were 82 (18.3%) recurrences. There were fewer recurrences in the

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sublay group than in the underlay group (9.4% vs 22.4%, p=0.001) (table 3). On multivariable

analysis, factors that contributed to SSI were mesh location, mesh type, fascial release,
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incisional hernia type, and acute repair. The variables that contributed to recurrence were mesh

location, wound class, and skin flaps (table 4). Based on the Kaplan-Meier curve (figure 3),
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hernia recurrences occurred more frequently in the underlay group. Furthermore, recurrences
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continued to occur throughout the follow-up period, although the rate of occurrence appeared to
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be similar after the first 10 months.

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On subgroup analysis of elective, midline incisional hernias only (n=247), there were more SSIs

with sublay compared to underlay repair (28.0% versus 15.1%, p=0.018); however, there was
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no difference in major SSI (sublay 9.3% versus underlay 5.8%, p=0.315). There were fewer
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recurrences using sublay repair compared to underlay repair (10.7% versus 25.0%, p=0.010).

Discussion:

In this multi-institution, risk-adjusted study of OVHR, there was no difference in SSI rates

between sublay and underlay mesh placement; however, sublay repair was associated with

substantially lower rate of hernia recurrence. This study represents the largest study comparing

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underlay and sublay repair in open ventral hernia repair.16 In a prospective cohort study of

OVHRs comparing sublay with underlay repair (the Repair of Infected or Contaminated Hernias

or RICH study), patients had similar rates of SSIs, seromas, and hematomas with both types of

repair despite a larger defect size with sublay mesh placement.17 There were fewer recurrences

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with sublay repair (10% versus 30%) at 1 year follow up, although the results were not

statistically significant due to small sample size.6 Similarly, data from the Danish Ventral Hernia

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Database, a prospective nationwide study on elective incisional hernia repairs demonstrated a

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lower reoperation rate for recurrence for onlay (16.1%, n=454) and underlay (21.2%, n=258)

repairs versus sublay (12.1%, n=323) repair at 48 months follow up.9 However, this study

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included both laparoscopic and open repairs in their underlay group. Given these results, a

future randomized controlled trial (assuming alpha=0.05 and beta=0.20) would require 200-300
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eligible patients.
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There are several potential explanations for the lower recurrence rates with sublay repair than
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underlay. Sublay repair may allow for tissue ingrowth on both sides of the mesh, while underlay
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repair can only have ingrowth in one direction.18 With sublay repair, the mesh is exposed to the

load-bearing and highly vascular rectus myofascial complex on the anterior surface and to the
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posterior fascial sheath. In contrast, with underlay repair the mesh is exposed to the

peritoneum, the body’s natural anti-adhesion barrier. While it remains under-investigated,

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placement of mesh in these different locations may result in differences in tissue ingrowth, mesh
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incorporation, and mesh-tissue burst/tear strength.8 This study suggests a measurable clinical

difference for sublay versus underlay mesh placement.

Contrary to our hypothesis, no difference in the rate of SSI following OVHR with sublay mesh

placement versus underlay mesh placement was detected. (table 3) Other studies have also

demonstrated similar rates of SSI using sublay and underlay repair.6,19 One possibility is that

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this study was underpowered to detect a difference in SSIs between sublay and underlay.

Another possibility is that there was residual confounding despite statistical adjustment for

known differences in baseline characteristics between groups. In order to analyze a more

homogeneous subset, a subgroup analysis of only elective, midline, incisional hernias was

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performed; sublay repair was associated with more SSIs than underlay repair; however, there

was no difference in major SSIs. It is possible that the increased dissection and devascularized

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skin flaps created with the sublay approach may result in an increase in superficial SSI

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compared to underlay repairs. Although there is an association between SSIs and recurrence,

there may still be an overall benefit to sublay repair given that the benefit in risk of recurrence

persisted on subgroup analysis despite the increased risk of superficial SSIs.20

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Other variables that contributed significantly to SSI were use of synthetic mesh, fascial release,

incisional hernia type, and acute repair. All of these factors are well-recognized factors
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contributing to wound complications with abdominal surgery and OVHR.21 Because all types of
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synthetic mesh were grouped together in this analysis, no definitive conclusions can be drawn
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on mesh types; in general, however, during the study period, the surgeons largely utilized low-

to mid-density macroporous meshes.21 While no randomized controlled trials comparing

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synthetic and biologic mesh exist, in complex and contaminated ventral hernia repairs, biologic

mesh may be more resilient to bacteria and associated with a lower rate of SSI.22 The use of
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fascial release may be associated with SSI through two mechanisms: fascial release may be
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simply a marker for more complex ventral hernias that are prone to develop a SSI. In addition,

fascial release in itself may be associated with increased risk for SSI by creating dead space

and devascularized tissue flaps. Along these lines, incisional hernias are more complicated

repairs than primary ventral hernias.5,9 Furthermore, acute repairs have been shown to have

significantly higher rates of infection than elective repairs owing to higher risk patients or the

presence of contamination.23

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There were several limitations to this study. First, this was a retrospective study affected by

selection bias and treatment variations. There were differences between the groups. Attempts

were made to control for this by using multivariate analysis and subgroup analysis. Even after

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controlling for these confounders, sublay placement of mesh was associated with lower rates of

recurrence. Other variables, such as surgeon and hernia size, were found not contribute

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significantly to the multivariate models or created an unstable model and were thus left out.

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These variables may still be important factors in hernia recurrence and SSI; however, they may

be collinear with variables that have a stronger association with the outcomes. Further studies

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should address this. In addition, patients were included with one month of follow-up. However,

over 50% of the patients had greater than one year of follow-up (median follow-up was 13.6
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months). In addition, we adjusted for follow-up duration in the multivariate analyses by using a

Cox proportional hazards model. Third, SSI, hernia recurrence, wound class, and ASA remain
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subjective in their determination. Numerous studies have demonstrated significant inter-rater

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variability in reporting these variables.24 To overcome this, we utilized standardized definitions,

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trained abstractors, and audited review of at least 10% of random charts for accuracy by

primary investigators. Hernia recurrence was determined clinically or radiographically, but there
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is considerable discrepancy in what different clinicians classify as a recurrence.25 In future

prospective studies, more stringent guidelines could be used to determine SSI, wound class,
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and recurrence. Fourth, it is unclear if sublay repair is generalizable to all hernia and patient
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types. Sublay repair without an accompanying posterior component separation is limited in the

repair of lateral or off midline hernias. In addition, there may be a higher risk of bleeding due to

increased dissection. It may not be feasible in patients who have damage to the peritoneum or

posterior rectus sheath. In these situations, underlay repair may be a better option. Finally, not

all outcomes of importance were assessed including impact on future surgery and patient-

reported outcomes.

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Conclusions

In our multi-center, risk-adjusted study, ventral hernia repair with sublay mesh placement was

associated with fewer recurrences compared to underlay mesh placement; however, surgical

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site infection rates were not decreased overall. This study is the largest study comparing

underlay and sublay repair in open ventral hernia repair; however, due to the limitations in study

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design the results are hypothesis generating only and provides realistic point-estimates for

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sample size calculation. The next best study is a randomized controlled trial to validate these

results.

Acknowledgements
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Lillian S Kao for her mentorship, Curtis J Wray for mentorship on analysis, and Jiandi Mo for

statistical analysis.
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Disclosures
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Mike K. Liang
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This work was supported by the Center for Clinical and Translational Sciences, which is funded

by National Institutes of Health Clinical and Translational Award UL1 TR000371 and KL2
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TR000370 from the National Center for Advancing Translational Sciences. The content is solely

the responsibility of the authors and does not necessarily represent the official views of the
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National Center for Research Resources or the National Institutes of Health.

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10. Surgical Site Infection (SSI). Healthcare-associated Infections (HAIs) 2010. Accessed November,

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Hernia Repair: A Systematic Review and Network Meta-analysis. World J Surg. In press.

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Mesh Location Figures and Tables

Figure 1: Mesh locations. A) onlay repair B) inlay repair C) sublay repair D) underlay repair;

key: blue= mesh, red= muscle, black= fascia, grey= hernia sac

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Figure 2: Patient flow-chart

Figure 3: Kaplan Meier for recurrence of overall cohort, p=0.001

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Table 1: Demographic and comorbidity data

Overall Cohort (N=447)
Total Underlay Sublay p-value
(n=447) (n=308) (n=139)
Age (years)* 51±13 51±14 52±12 0.32

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Ethnicity 0.01
White 231 (51.7%) 146 (47.4%) 85 (61.2%)
Other 216 (48.3%) 162 (52.6%) 54 (38.9%)
Gender (male) 222 (49.7%) 146 (47.5%) 76 (54.7%) 0.16

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ASA score
1 21 (4.7%) 16 (5.2%) 5 (3.6%) 0.34
2 226 (50.6%) 147 (47.7%) 79 (56.8%)

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3 180 (40.3%) 130 (42.2%) 50 (36.0%)
4 20 (4.5%) 15 (4.9%) 5 (3.6%)
BMI* 33.5±7.7 33.8±8.1 33.0±6.8 0.55
Smoker 108 (24.2%) 75 (24.4%) 33 (23.7%) 0.89

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COPD 29 (6.5%) 20 (6.5%) 9 (6.5%) 0.99
DM 97 (21.7%) 69 (22.4%) 28 (20.1%) 0.59
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Immunosuppressed 27 (6.0%) 20 (6.5%) 7 (5.0%) 0.55
Steroid use 16 (3.6%) 13 (4.2%) 3 (2.2%) 0.28
Albumin 3.72±0.60 3.72±0.60 3.74±0.58 0.76
Prostate disease 9 (2.0%) 7 (2.3%) 2 (1.4%) 0.56
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Aneurysmal disease 5 (1.1%) 3 (1.0%) 2 (1.4%) 0.67

Alcohol use disorder 16 (3.6%) 13 (4.2%) 3 (2.2%) 0.28
Prior SSI 41 (9.2%) 33 (10.7%) 8 (5.8%) 0.09
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*
mean ± standard deviation
ASA=American society of anesthesiologist score
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BMI=body mass index in kg/m2

COPD=chronic obstructive pulmonary disease
DM=diabetes mellitus
SSI=surgical site infection
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Table 2: Univariate analysis of hernia and operative detail

Overall Cohort (N=447)
Total Underlay Sublay p-value
(n=447) (n=308) (n=139)
Hernia type
Primary 109 (24.4%) 55 (17.9%) 54 (38.9%) <0.01

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Incisional 338 (75.6%) 253 (82.1%) 85 (61.2%)
History of prior hernia repair 149 (33.3%) 107 (34.7%) 42 (30.2%) 0.35
Hernia area (cm2)* 80.1±6.07 80.1±7.71 80.2±9.35 0.52
Hernia location

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Medial 373 (91.0%) 266 (89.3%) 107 (95.5%) <0.05
Lateral 37 (9.0%) 32 (10.7%) 5 (4.5%)
Acute repair 69 (15.4%) 61 (19.8%) 8 (5.8%) <0.01

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Wound class
1 276 (70.8%) 171 (67.1%) 105 (77.8%) 0.10
2 72 (18.5%) 56 (22.0%) 16 (11.9%)
3 33 (8.5%) 22 (8.6%) 11 (8.2%)

U
4 9 (2.3%) 6 (2.3%) 3 (2.2%)
Concomitant procedure 81 (18.2%) 62 (20.1%) 19 (13.8%) 0.11
AN
Fascial release 106 (23.7%) 51 (16.6%) 55 (39.6%) <0.01
Skin flaps 197 (44.1%) 140 (45.5%) 57 (41.0%) 0.38
Mesh type
Biologic 165 (37.1%) 127 (41.5%) 38 (27.3%) <0.01
M

Synthetic 280 (62.9%) 179 (58.5%) 101 (72.7%)

Length of surgery (min)** 135 (23-3226) 135 (23-3226) 135 (26-421) 0.46
Surgical drains 194 (43.4%) 135 (43.8%) 59 (42.5%) 0.78
D

**
mean ± standard error of the mean
**
median (range)
TE

min=minutes
C EP
AC

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Table 3: Outcomes from all open ventral hernia repairs

Total Underlay Sublay p-value
(n=447) (n=308) (n=139)
SSI (all) 79 (17.7%) 50 (16.2%) 29 (20.9%) 0.24
Major SSI 30 (6.7%) 22 (7.1%) 8 (5.8%) 0.59

PT
Recurrence 82 (18.3%) 69 (22.4%) 13 (9.4%) <0.01
Follow-up duration (mo)** 13.6 (1.0-50.1) 13.6 (1.0-48.8) 13.8 (1.0-50.1) 0.64
**
median (range)
SSI=surgical site infection

RI
Major SSI= deep and organ space SSI
mo=months

SC
Table 4: Multivariable analysis for surgical site infection and Cox regression for recurrence
following open ventral hernia repairs
Main Analyses of Overall Cohort (n=447)
SSI Recurrence

U
Variable OR (95% CI) p-value HR (95% CI) p-value
Mesh location
AN
Underlay ref 0.17 Ref <0.01
Sublay 1.51 (0.84-2.75) 0.41 (0.22-0.77)
Mesh type
Biologic Ref 0.17 -
M

Synthetic 1.59 (0.82-3.10) -

Fascial release 1.65 (0.82-3.32) 0.16 -
Hernia type
D

Primary Ref 0.09 -

Incisional 1.87 (0.90-3.88) -
Acute repair 2.58 (1.31-5.07) <0.01 -
TE

Wound class 3-4 - 3.54 (2.11-5.94) <0.01

Skin Flaps - 1.51 (0.90-2.52) 0.12
C EP
AC

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