2. Paper
Evaluating the Impact of Technique and Mesh
Type in Complicated Ventral Hernia Repair: A
Prospective Randomized Multicenter Controlled
Trial
Grant V Bochicchio, Alvaro Garcia , Jarrod Kaufman , Qiao Zhang , Christopher
Horn , Kelly Bochicchio , Bryan Sato , Stacey Reese , Obeid Ilahi
Department of Surgery, Washington University School of Medicine, St Louis, MO.
Electronic address: bochicchiog@wustl.edu.
Published:
January 29, 2019 DOI:https://doi.org/10.1016/j.jamcollsurg.2019.01.012
3. Outline
1. Anatomy Of Repair
2. Background and Rationale
3. Study design and Analysis
4. Inclusion and Exclusion Criteria
5. Outcomes and Follow up
6. Results
7. Risk factors for recurrence
8. Brief Discussion
9. Conclusion
10. Strengths and Weakness
11. Take home message
5. Background and Rationale
Lack of prospective randomized multicenter controlled trials
For decades, surgeons have continued to debate about superiority of one repair
technique and optimal Mesh type for Ventral hernia repairs.
No exact consensus
Evolution in reconstruction techniques: Component separation
2 TECHNIQUES:
Overlay( anterior comp separation) VS Sublay ( Posterior comp separation)
2 MESH TYPES( BIOLOGICAL ONLY):
HADM ( Human acellular dermis) VS PADM ( Porcine acellular dermis)
6. Study design and Analysis
Prospective randomized multicenter double blinded controlled trial
3 centres, finally pooled 120 patients , average 30 in each of 4 arms
Proctered animal lab, porcine model for surgeons training
Proctered Lead investigator for first case
Strict Inclusion and exclusion criteria
80% power
95% significance with 1-sided test
Continuous variable by t-test and 1-way ANOVA
Assumed recurrence rates were 35% for HADM and 15% for PADM
4 study arms. Univariate analysis
P< 0.020
Quality of life impact by SF-36v2 survey
8. Key Inclusion and Exclusion criteria
Inclusion:
1. Hernia size >200cm2
2. BMI < 40Kg/m2
3. HBA1C < 7%
4. Tobacco free > 6 weeks
5. Primary closure
6. Life exp > 1 year
7. Informed consent
Exclusion:
1. Age <18
2. Primary closure not possible
3. Necrotizing facsitis
4. Collagen disorder
5. Active Malignancy
6. Chemotherapy
7. Cirrhosis
9. Procedures
Ramirez and Colleagues Technique
4 ARMS of study
2 Techniques of dissection and mesh placements
2 Biomesh types
Anterior component separation : Ant rectus, ext oblique
OVERLAY MESH Placement
Posterior component separation : post rectus sheath, Transv Abd
RETRO-RECTUS OR SUBLAY MESH placement
Drain placements: At discretion of investigator
10. Determination of Outcomes and
follow up
Primary outcome:
True Recurrence determined by independent examination/ CT scan,
Infections, collections, Fistula, mesh failures =/< 1 YEAR
Secondary Outcome:
Functional laxity
Patient satisfaction / quality of life ( short form 36 item version 2)
Follow up:
1-6 week post op visit
3 month, 6 month and 12 month : photos, examination, CT scan
11. Results
Overall 1 year Recurrence rate = 10.8% ( 13 patients)
No Significant difference in Recurrence rate by Technique of mesh placement and
neither the Mesh type used :
Overlay 9.8% vs Underlay 11.9%
HADM 10.3% vs PADM 11.3%
Overlay had significantly lower SSI rate: (Overlay 1.6% vs 11.9% p=0.03)
Overlay reported better physical functioning( p=0.001) and role limitation
scores(p=0.04)
Overlay group achieved highest physical functioning score in 1 year time (p<0.03)
12. Further Results
No significant difference in Demographics between 4 groups:
Age= 60+/-12 years , BMI= 32+/-5 kg/m2 , gender= Female 51%
83% ( 100 patients) had their hernia for >1 year
97.5% ( 117 patients) had at least 1 previous abdominal wall hernia repair
Underlay patients were slightly older 63 vs 58 years (p=0.03)
Seroma rate higher in Overlay group ( 26% vs 8.5%, p=0.01)
Further stratified analysis showed overall lowest SSI rates in HADM Overlay group,
p=0.05
Overall 1 mortality, 1 enterocutaneous fistula, 18 were contaminated procedures
14. Discussion
Large number of different techniques stem from the fact that no single technique has
stood out as being significantly superior
Anterior Component separation ( Ramirez& Colleagues) stems from the need to advance
fascia layers to close large facial defects
Posterior component separation was introduced to avoid creating large flaps and
decrease complications
In this trial, there was no Significant difference in both techniques in primary outcome :
Recurrence
Hence this suggests that tension free midline closure + Mesh support is the most
important factor in prevention of Hernia recurrence.
Langer and coauthors concluded in a 25 year comparative retrospective study that most
important prognostic factor was Experience and skill of Surgeon
Knowledge of prosthetic materials, skill for techniques and when to involve plastic
surgeons is key.
15. Further discussion
The SSI rate was higher in Underlay group and this was an unexpected outome
perhaps because of following 2 reasons:
1. In Overlay approach, Drains are widely placed above the mesh and help prevent
infection
2. Bacterial proliferation is higher in Underlay group
HADM has higher tensile strength and faster tissue ingrowth in Rabbit models (
Ngo and Colleagues)
Lowest SSI rate seen in HADM Overlay group which might be due to Faster tissue
ingrowth as in animal models, as well as due to Drain protection.
Further research is needed to better understand the findings of better Physical
outcome in Overlay group .
16. Conclusions
First prospective Randomized trial evaluating the Mesh type(biological)
and Surgical Technique of Component separation
No Significant difference in Recurrence Rates at 1 year between 4 groups.
Overlay group had Advantages of Lower Surgical Site infection and
Improved Physical functioning over 1 year study period.
As expected, Overlay group did have higher Seroma Rate.
Further research is needed to better understand the nature of these
differences.
17. Strengths And Weakness
Strengths
Well controlled & well analyzed
Randomized prospective
Good follow up %
Different results as compared to usual
data in literature
Helpful in understanding the patient
selection
Weakness
Drains data lacking
Size of hernia defect . width x height
VS height x width
Small sample size
Short follow up timeframe
Why not synthetic mesh
Nicotine levels check preop
No definition of Recurrence and not
all patient got CT confirmation
18. Take Home Message
Complicated ventral hernia repairs should be individualized , keeping in-line with
current standard guidelines available.
Technique of mesh placement is largely dependent upon Patient selection and
Surgeons preference and skill.
Mesh type is still an ongoing dilemma , Synthetic vs biological.
Drain placement is a 2 edged sword! But we Surgeons prefer putting it.
Long Follow up is vital for determining Recurrence.
Pre-op Smoking cessation And Weight loss are significantly helpful.