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Complicated Ventral Hernias
Repair, Impact of Technique &
Mesh type
Journal Club Presentation
Dr. Haris Bela
Registrar Surgery
UHK Tralee
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
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
(Sublay )
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)
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
 120 patients , 3 centres in USA
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
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
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
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)
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
Significant Risk factors for Recurrence
 BMI
 Previous operations / Hernial repairs
 Hernia size
 Smoking
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.
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 .
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.
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
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.
THANK YOU VERY MUCH
 Open discussion please

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Ventral hernia Update and Journal Club.pptx

  • 1. Complicated Ventral Hernias Repair, Impact of Technique & Mesh type Journal Club Presentation Dr. Haris Bela Registrar Surgery UHK Tralee
  • 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
  • 7.  120 patients , 3 centres in USA
  • 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
  • 13. Significant Risk factors for Recurrence  BMI  Previous operations / Hernial repairs  Hernia size  Smoking
  • 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.
  • 19. THANK YOU VERY MUCH  Open discussion please