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Original Scientific Articles

Biologic vs Synthetic Mesh for Parastomal Hernia Repair: Post Hoc Analysis of a Multicenter Randomized Controlled Trial

Miller, Benjamin T MD; Krpata, David M MD, FACS; Petro, Clayton C MD, FACS; Beffa, Lucas R A MD, FACS; Carbonell, Alfredo M DO, FACS; Warren, Jeremy A MD, FACS; Poulose, Benjamin K MD, MPH, FACS; Tu, Chao MS; Prabhu, Ajita S MD, FACS; Rosen, Michael J MD, FACS

Author Information
Journal of the American College of Surgeons: September 2022 - Volume 235 - Issue 3 - p 401-409
doi: 10.1097/XCS.0000000000000275
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Parastomal hernias affect almost 50% of people with an enterostomy,1,2 causing abdominal pain, bowel obstructions, pouching difficulties, and skin breakdown.3,4 More than a third of those experiencing a parastomal hernia eventually undergo repair.5 More than 90% of parastomal hernias are repaired with mesh,6,7 as reinforcement of the stoma aperture reduces parastomal hernia recurrences.8 However, the presence of an ostomy increases the wound class from clean to clean-contaminated/contaminated and makes the choice of mesh more controversial than in a strictly clean case.

Biologic mesh is often preferred in contaminated cases, but it costs more than synthetic mesh and may have higher failure rates.9 Synthetic mesh is a less expensive alternative and may be more durable, but it is often avoided in parastomal hernia repairs because it may be more susceptible to infection and may erode into the ostomy.10 However, no studies have compared the outcomes of biologic vs synthetic mesh for parastomal hernia repairs.

We performed a post hoc analysis of a large group of patients undergoing parastomal hernia repairs in a recently published randomized, controlled trial (RCT) comparing biologic and synthetic mesh for the repair of clean-contaminated and contaminated open retromuscular ventral hernias. The aim of this study is to compare the outcomes of biologic and synthetic mesh in parastomal hernia repairs.

METHODS

This is a post hoc analysis of a multi-center, single-blinded, parallel-group RCT, which compared biologic with synthetic mesh for the single-staged repair of clean-contaminated and contaminated (Centers for Disease Control class II and III) ventral hernias.11 Patient enrollment and operations occurred at 5 academic medical centers with dedicated abdominal wall reconstruction units. The trial was registered with the Food and Drug Administration as an Investigational Device Exemption Trial (IDE# G120130) and at ClinicalTrials.gov (NCT#02451176). Institutional review board approval was granted at participating sites before enrollment, and all study participants provided written informed consent.

Patients included in this analysis underwent open retromuscular parastomal hernia repair with either biologic (Strattice Reconstructive Tissue Matrix, Lifecell Corp, Branchburg, NJ) or medium-weight polypropylene mesh (Bard Soft Mesh, CR Bard, Murray Hill, NJ). All operations were performed by general surgeons with advanced training in abdominal wall reconstruction. Open retromuscular parastomal hernia repair involves a Rives-Stoppa retrorectus dissection followed by transversus abdominis release. Mesh configuration options during open parastomal hernia repair included a retromuscular keyhole12 or retromuscular Sugarbaker13 technique. The retromuscular keyhole mesh configuration was approached by either slitting the mesh or by making a cruciate incision in the mesh. Mesh configuration for the parastomal hernia repair during this study was left to the discretion of the operating surgeon.

Outcomes included surgical site occurrences requiring procedural intervention (SSOPI) rates, reoperation rates, stoma/mesh-related adverse events, mesh excisions up to 24 months postoperatively, parastomal hernia recurrence rates at 2 years (yes or no), and quality of life up to 2 years. Total hospital costs up to 30 days postoperatively and mesh cost were also assessed. SSOPIs, reoperations, parastomal hernia recurrences, and quality of life scores were captured at 1 (± 15 days), 6 (± 2 months), 12 (± 2 months), and 24 (± 4 months) months.

Surgical site occurrences were defined as previously described in the original trial.11 Parastomal hernia recurrence was defined as a bulge on physical exam in the vicinity of the stoma while standing or supine, as a patient-reported bulge near the stoma, or as a separate and distinct segment of bowel or other intra-abdominal contents in the musculofascial aperture on CT. CT scans were interpreted by 3 surgeons blinded to the patient, operating surgeon, and surgical technique. Consensus of at least 2 of 3 surgeons’ reviews of the CT scan was required to define a recurrence.

Quality of life assessments included the EQ-5D descriptive system, which evaluates mobility, self-care, activity performance, social relationships, pain, and mood, the EQ-5D Visual Analog Scale (VAS), which scores health from 0 to 100, with 0 being the worst health and 100 the best health,14 and the disease-specific Hernia Related Quality of Life Survey (HerQLes), for which higher scores indicate higher abdominal wall–related quality of life.15 Total hospital costs, abstracted directly from hospital accounting, included patient visits, admissions, mesh, and all procedures from the operation to 30 days postoperatively. Institutional overhead (indirect) costs were excluded.

Statistical analysis

Rates of SSOPIs between biologic and synthetic mesh, assessed by 4 repeated binary measurements, were analyzed with a generalized mixed-model analysis with repeated measures. Composite parastomal hernia recurrence was categorized as binary (yes or no) and analyzed using Chi-squared testing. Time to recurrence was analyzed with log-rank testing and Cox proportional hazards models with prespecified covariates. Further subgroup analysis of keyhole vs Sugarbaker mesh configurations was performed using Chi-squared testing. The relationships of patient pain and quality of life to mesh type were analyzed with mixed-effect linear regression models with repeated measurements. Cost differences were compared using Wilcoxon rank sum tests. No data were imputed for missing variables. All analyses, performed using R software (version 4.0.0, Vienna, Austria), were considered significant at a 5% level.

RESULTS

Patient and operative characteristics

Of the 108 patients included in the parastomal hernia repair analysis, 57 (53%) received biologic mesh and 51 (47%) received synthetic mesh. At 2 years, overall patient follow-up was 90.8%. There were 87 patients (80.6%) with clinical follow-up (49 [86.0%] biologic vs 38 [74.5%] synthetic; p = .21), 65 patients (60.2%) with radiographic follow-up (34 [59.6%] biologic vs 31 [60.8%] synthetic; p = 1.00), and 11 patients (10.2%) with patient-reported follow-up only (4 [7.0%] biologic vs 7 [13.7%] synthetic; p = .41). Patient demographics and baseline comorbid conditions were similar between the 2 groups (Table 1). Approximately half of the patients had a previous parastomal hernia repair. Stoma types (urinary conduits, end ileostomies, and colostomies) were evenly distributed between biologic and synthetic mesh. No significant differences in operative details were observed (Table 2). Most patients in both treatment arms underwent concomitant midline incisional hernia repair (50 biologic [87.7%] vs 48 synthetic [94.1%]; p = .33). There was a similar distribution of keyhole and retromuscular Sugarbaker repairs in the biologic and synthetic mesh cohorts (keyhole repair: 43 [75.4%] biologic vs 36 [72.0%] synthetic, retromuscular Sugarbaker repair: 14 [24.6%] biologic vs 14 [28.0%] synthetic; p = .86).

Table 1. - Patient Demographics, Comorbid Conditions, and Stoma, Hernia, and Wound Characteristics
Variable Biologic mesh, N = 57 Synthetic mesh, N = 51
Sex, m, n (%) 33 (58) 29 (57)
Age, y, median (IQR) 63.0 (56–72) 63.4 (59–71)
BMI, kg/m2, median (IQR) 32.1 (29–35) 31.7 (27–35)
Obesity (BMI > 30kg/m2), n (%) 34 (60) 28 (55)
Hypertension, n (%) 37 (65) 29 (57)
Smoking history, n (%) 35 (61) 29 (57)
Diabetes, n (%) 15 (26) 8 (16)
COPD, n (%) 7 (12) 3 (6)
CHF, n (%) 3 (5) 0 (0)
Previous DVT, n (%) 8 (14) 4 (8)
Previous PE, n (%) 4 (7) 6 (12)
Crohn’s disease, n (%) 11 (19) 5 (16)
Ulcerative colitis, n (%) 10 (18) 8 (16)
History of cancer, n (%) 28 (49) 26 (51)
Previous radiotherapy, n (%) 11 (19) 10 (20)
Serum HbA1c, median (IQR) 5.7 (5.4–6.1) 5.7 (5.4–6.1)
Stoma type, n (%)
 Urinary conduit 19 (33) 19 (37)
 End ileostomy 24 (42) 17 (33)
 End colostomy 16 (28) 17 (33)
Recurrent parastomal hernia, n (%) 24 (42) 26 (51)
History of abdominal wall infection, n (%) 7 (12) 3 (6)
Nonhealing abdominal wound, n (%) 2 (4) 1 (2)
All p values > 0.05.
CHF, congestive heart failure; DVT, deep venous thrombosis.

Table 2. - Operative Detail
Variable Biologic mesh Synthetic mesh p Value
ASA classification, n (%) .76
 2 7 (12) 5 (10)
 3 49 (86) 46 (90)
 4 1 (2) 0 (0)
Operating room time, mins, median (IQR) 238 (184–313) 228 (181–316) .56
Abdomen entered midline laparotomy 57 (100) 51 (100) 1.0
CDC wound class, n (%) .26
 Class 2 23 (40) 27 (53)
 Class 3 34 (60) 24 (47)
Concomitant procedure, n (%) .97
 Bowel resection 18 (32) 15 (29)
 Cholecystectomy 2 (4) 0 (0)
 Appendectomy 1 (2) 0 (0)
 Urologic procedure 10 (18) 8 (16)
Enterotomy, n (%) 0 (0) 1 (2)
Type of hernia, n (%) .33
 Parastomal only 7 (12) 3 (6)
 Parastomal and midline 50 (88) 48 (94)
Hernia width, cm, median (IQR)* 13.0 (11.0–15.0) 13.0 (10.5–15.0) .24
Hernia length, cm, median (IQR)* 22.0 (18.0–25.0) 21.0 (18.0–25.0) .68
Mesh/defect ratio, median (IQR) 2.9 (2.1–3.8) 3.2 (2.6–4.0) .07
Transversus abdominis release, n (%) 55 (96) 48 (96) .22
Ostomy disposition, n (%) .36
 Left in situ at original site 23 (40) 26 (51)
 Moved to another site 34 (60) 25 (49)
Retromuscular mesh configuration, n (%) .86
 Keyhole/cruciate 43 (75) 36 (72)
 Sugarbaker 14 (25) 14 (28)
Estimated blood loss, mL, median (IQR) 150 (100–200) 100 (100–200) .37
Hospital length of stay, d, median (IQR) 6.5 (5.75–10.0) 8.0 (6.0–9.3) .17
*Hernia measurement according to European Hernia Society classification with both midline and parastomal component.
ASA, American Society of Anesthesiology; CDC, Centers for Disease Control.

SSOPIs and reoperations

There were 39 total SSOPIs experienced by 32 patients (29.6%) at 2 years. Of the 32 patients with SSOPIs, 14 (24.6%) had biologic mesh and 18 (35.3%) had synthetic mesh (absolute risk difference –10.7% [CI –29.8% to 8.36%]; p = .31). Rates of SSOPIs were similar between treatment arms at all time points assessed (Table 3), and a generalized mixed-effect model analysis with repeated measures of SSOPIs found no significant difference between mesh types up to 24 months postoperatively (OR 0.37, CI 0.11–1.27; p = .16). Reoperation rates for biologic and synthetic mesh were comparable throughout the study (Table 4). Reoperations for parastomal hernia recurrences were not significantly different between biologic and synthetic mesh up to 24 months postoperatively. Four mesh-related erosions requiring reoperation and stoma revision occurred after keyhole repairs (2 biologic vs 2 synthetic). No mesh infections requiring mesh excision occurred.

Table 3. - Summary of Surgical Site Occurrence Requiring Procedural Intervention During the Study Period
SSOPI Biologic Synthetic p Value
1 month 12 (21.1%) 16 (31.4%) .32
6 months 3 (5.3%) 4 (7.8%) .71
1 year 0 (0.0%) 1 (2.0%) .47
2 years 1 (1.8%) 2 (4.0%) .60
Data presented as n (%)
SSOPI, surgical site occurrence requiring procedural intervention.

Table 4. - Indications for Reoperation During the Study
Time Indication for reoperation AllN = 108 BiologicN = 57 SyntheticN = 51 p Value
30 days Overall 5 (4.6) 4 (7.0) 1 (2.0) .37
Wound complication 1 (0.9) 1 (1.8) 0 (0) 1.00
Bleeding 1 (0.9) 1 (1.8) 0 (0) 1.00
Bowel obstruction 2 (1.9) 2 (3.5) 0 (0) .50
Other intraabdominal pathology 1 (0.9) 0 (0) 1 (2.0) .47
6 months Overall 8 (9.1) 2 (4.1) 6 (15.4) .13
Wound complication 4 (3.7) 1 (1.8) 3 (5.9) .34
Ventral hernia recurrence 1 (0.9) 0 (0) 1 (2.0) .47
Bowel obstruction 2 (1.9) 1 (1.8) 1 (2.0) 1.00
Other intra-abdominal pathology 3 (2.8) 0 (0) 3 (5.9) .10
Parastomal hernia recurrence 2 (1.9) 0 (0) 2 (4.0) .22
1 year Overall 4 (3.7) 1 (1.8) 3 (5.9) .31
Ventral hernia recurrence 3 (2.8) 1 (1.8) 2 (4.0) .60
Other intra-abdominal pathology 1 (0.9) 0 (0) 1 (2.0) .47
Parastomal hernia recurrence 3 (2.8) 1 (1.8) 2 (4.0) .60
2 years Overall 10 (9.3) 7 (12.3) 3 (5.9) .34
Wound complication 2 (1.9) 1 (1.8) 1 (2.0) 1.00
Ventral hernia recurrence 9 (8.3) 6 (10.5) 3 (5.9) .50
Bowel obstruction 1 (0.9) 1 (1.8) 0 (0) 1.00
Parastomal hernia recurrence 5 (4.6) 4 (7.0) 1 (2.0) .37
Data presented as n (%).

Parastomal hernia recurrence

At 2 years, 30 (27.8%) patients experienced parastomal hernia recurrence. Recurrence rates were similar for biologic compared with synthetic mesh (17 [29.8%] vs 13 [25.5%], absolute risk difference 4.3% (CI –14.4% to 23.0%), respectively; p = .78). Time to hernia recurrence was not significantly different between mesh materials (Fig. 1). On multivariate Cox regression analysis, mesh type, defect size, and mesh-to-defect ratio did not influence parastomal hernia recurrence rates (Table 5).

Table 5. - Multivariate Cox Model for Hernia Recurrence Rate
Time to recurrence regression model
Predictor Hazard ratio 95% CI p Value
Rand factor: synthetic vs biologic 1.09 0.51–2.30 .83
Site factor: hospitals (01) 1.03 0.38–2.79 .96
Site factor: hospitals (02, 03, 04) 1.09 0.31–3.66 .93
Age (25th to 75th: 57.5 to 71.1) 0.85 0.51–1.40 .53
Sex factor: female 1.04 0.48–2.23 .93
BMI (25th to 75th: 28.6 to 34.9) 1.37 0.78–2.39 .28
Ever smoked factor: No 0.96 0.43–2.12 .91
Defect size (25th to 75th: 214.5 to 369.5) 1.25 0.73–2.13 .41
Mesh/defect ratio (25th to 75th: 2.40 to 3.96) 1.56 0.94–1.07 .99
Observations 108
R2 Nagelkerke 0.021

F1
Figure 1.:
Kaplan-Meier plot of time to hernia recurrence.

Parastomal hernia repair technique

Hernia recurrence rates between the retromuscular keyhole and retromuscular Sugarbaker mesh configurations were not significantly different at 2 years (28 [30.4%] vs 79 [10.7%], respectively; p = .07). A subgroup analysis of the keyhole mesh configuration found no significant differences in parastomal hernia recurrences between the keyhole and cruciate configurations (8 [26.7%] vs 18 [60.0%], respectively; p = .30).

Quality of life and cost

Patient quality of life in terms of EQ5D, EQ5D VAS, and HerQLes scores improved from baseline and was similar up to 24 months postoperatively for biologic and synthetic mesh (Fig. 2). Median 30-day total hospital cost and median mesh price for biologic mesh were significantly higher than synthetic mesh ($44,187 [$34,858 to $50,893] vs $15,975 [$12,426 to $17,712], respectively, p < .001; and $23,026 [$20,285 to $23,332] vs $105 [$105 to $112], respectively, p < .001).

F2
Figure 2.:
(A) EQ5D, (B) EQ5D VAS, and (C) HerQLes estimates from mixed-effect regression model adjusted for baseline differences.

DISCUSSION

This post hoc analysis found no significant differences in safety outcomes or 2-year hernia recurrence rates between biologic and synthetic mesh in the repair of parastomal hernias. Regardless of mesh type used, wound morbidity rates were high and nearly one third of patients experienced a parastomal hernia recurrence, highlighting the challenge of parastomal hernia repair. Still, quality of life improved from baseline for both biologic and synthetic mesh and was similar at 2 years postoperatively. Despite similar clinical and patient-reported outcomes between mesh types, biologic mesh had significantly higher 30-day total hospital costs, driven mainly by the price of the biologic prosthetic.

We assessed the safety of biologic and synthetic mesh for parastomal hernia repair by comparing wound morbidity, reoperations, mesh erosions, and mesh excision. Wound morbidity was high in our cohort, which is consistent with other recent studies16,17; however, both meshes performed similarly in terms of SSOPIs and reoperations, and no mesh excisions were required for either group. Although others have expressed concern for synthetic mesh erosion into stomas,18,19 our study found the same incidence of mesh erosions in both groups. Notably, all mesh erosions occurred in patients with a cruciate mesh configuration. These erosions were most likely technical errors, caused by misalignment of the apertures in the abdominal wall and mesh or inappropriately small cruciate mesh incisions. Our results indicate that biologic and synthetic mesh have similar safety profiles for retromuscular parastomal hernia repair. Their safety is further supported by trials assessing prophylactic mesh placement during enterostomy creation, which have not found more mesh-related stoma complications or any mesh infections in patients randomized to retromuscular biologic or synthetic mesh reinforcement.20-22 However, randomized trials may be underpowered to identify low-frequency complications which may nevertheless be associated with catastrophic outcomes. Larger, registry-based experiences of parastomal hernia repair with long-term follow-up are necessary to fully evaluate these concerns.

Despite advances in abdominal wall reconstruction techniques, our findings show that open retromuscular parastomal hernia repair has high recurrence rates, consistent with contemporary investigators using similar techniques. Beffa and colleagues16 found parastomal hernia recurrence rates of 21.7% at 21.5 months after open retromuscular parastomal hernia repair with synthetic mesh using a keyhole or cruciate mesh configuration. Using a keyhole configuration with biologic mesh, Valle de Lersundi and colleagues17 reported parastomal hernia repair failure rates of 45% at 30 months. These high failure rates, regardless of mesh type used, underscore the inherent challenge of parastomal hernia repair—a defect is left in the abdominal wall to accommodate the stoma. Our results indicate that mesh type does not play a major role in preventing parastomal hernia recurrences and that future studies should focus on mesh configuration to reduce repair failure rates.

The optimal mesh configuration during parastomal hernia repair remains unknown. The largest prospective studies evaluating retromuscular mesh in a keyhole or cruciate configuration are those assessing prophylactic mesh at enterostomy creation. These studies have conflicting results, however. The Dutch PREVENT trial found lower parastomal hernia rates at 1 year in the mesh group (4.5%) than in the no-mesh group (24.2%; p = .001),20 but the Swedish STOMAMESH trial found no difference in parastomal hernia rates at 1 year between patients who received mesh (34%) and those who did not (32%; p = .76).23 Likewise, the recent Stoma-const and GRECCAR 7 trials found no benefit from prophylactic synthetic mesh in a retromuscular position at enterostomy creation.24,25 An alternative mesh configuration, the retromuscular Sugarbaker approach, has promising short-term results, with 1 study finding parastomal hernia recurrence rates of 11% at 13 months.26 We also saw a trend toward lower failure rates for the retromuscular Sugarbaker compared with the keyhole mesh configuration. However, the retromuscular Sugarbaker mesh configuration had discouraging early results at our institution—mesh erosions into the stoma causing stoma necrosis, bowel obstruction, and bowel perforation requiring reoperation—attributed to lateral mesh fixation with trans-fascial sutures.27 After modifying the technique to place mesh without trans-fascial fixation sutures, fewer mesh-related complications have been observed by our group. Indeed, all mesh erosions into the stoma in this study occurred when a cruciate mesh configuration was used. Head-to-head studies comparing parastomal hernia repair techniques are needed. We are currently conducting a RCT comparing the retromuscular keyhole to the retromuscular Sugarbaker mesh configuration (ClinicalTrials.gov NCT03972553).

Although parastomal hernia repair is encumbered by wound problems and high failure rates, patient-reported outcomes indicate that it still improves quality of life. Overall and hernia-specific quality of life improved from baseline for both mesh types in this study and were similar up to 2 years postoperatively, consistent with previous work.6 We noted an overall improvement in quality of life, but we did not fully investigate other important patient-reported outcomes, such as decision regret28 and stoma-specific quality of life.29 Adding these validated tools to capture these data may help us gain a more holistic and multi-dimensional understanding of patients’ perceptions of their outcomes.

An additional consideration in mesh choice is cost, which was significantly higher for biologic mesh. Total cost at 30 days for biologic mesh was almost 3 times more than synthetic mesh, with the biologic prosthetic costing more than 200 times more than the synthetic device. Earlier cost analyses of synthetic and biologic mesh for ventral hernia repairs have found similar results.30,31 Given similar clinical and patient-reported outcomes for biologic and synthetic mesh, mesh cost should be considered when approaching parastomal hernia repair.

We acknowledge the limitations of post hoc analyses; namely, without prespecified outcomes, the study findings may be coincidental and should be considered exploratory. Another potential limitation is our definition of parastomal hernia recurrence. No standard clinical, radiographic, or patient-reported definition of parastomal hernia recurrence exists, so we used clinical and radiographic definitions similar to those of previous investigators32,33 and added patient-reported recurrence. Additionally, only 60% of patients had radiographic follow-up, potentially undercounting recurrences, as CT has been shown to be more sensitive for detecting parastomal hernia recurrences than physical exam.32 Furthermore, all operations in this study were performed by experienced abdominal wall reconstructive surgeons, perhaps limiting the generalizability of our results. Finally, other approaches to parastomal hernia repairs, including laparoscopic Sugarbaker-type repairs, were not performed in this study. However, in our hands, this approach is most suitable in patients without a midline defect and a relatively small parastomal hernia component. Nearly all patients in this study had accompanying complex midline defects.

CONCLUSIONS

Our post hoc analysis found that biologic and synthetic mesh perform similarly regarding our safety outcomes: wound morbidity, reoperation, and mesh erosion. Despite high rates of wound morbidity and hernia recurrence in both groups, patients appear to have an improved quality of life associated with parastomal hernia repair regardless of the mesh type used. Given similar clinical outcomes for both devices, biologic mesh cost should be considered when selecting mesh for repair. Further studies should evaluate the optimal mesh configuration in parastomal hernia repair.

Author Contributions

Study conception and design: Miller, Krpata, Petro, Beffa, Prabhu, Rosen

Acquisition of data: Miller, Krpata, Carbonell, Warren, Poulose, Prabhu, Rosen

Analysis and interpretation of data: Miller, Krpata, Petro, Tu, Rosen

Drafting of manuscript: Miller, Tu, Prabhu, Rosen

Critical revision: Miller, Krpata, Petro, Beffa, Carbonell, Warren, Poulose, Prabhu, Rosen

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