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Incisional hernia prevention
An Jairam
REPAIR research group
15th
of June 2018
Disclosure
No conflict of interest
Introduction
Incisional hernia
 Most frequent postoperative complication
 Incidence general population: 10-20%
 Incidence high risk groups: > 30%
>>> Prevention
Prevention of incisional hernia
Prophylactic mesh reinforcement – PRIMA trial
Small bites technique – STITCH trial
Profylactic mesh reinforcement
 1995, first study
 Studies 1998 - 2015
 Small patient numbers
 Mesh position: unclear
 Postoperative complications: unclear
Current guidelines
‘Larger trials are needed to make a strong recommendation to perform prophylactic
mesh augmentation for all patients within a certain risk group’
PRIMA Trial
Randomization
1) Primary Suture
 Hechten van de fascie
2) Onlay mesh reinforcement
3) Sublay mesh reinforcement
Endpoints
 Primary endpoint
 Incisional hernia incidence after 2 years follow-up
 Secondary endpoints
 Postoperative complications
 Quality of Life (EuroQoL-5D, SF-36)
 Pain
 Cost-effectiveness
Methods
 Inclusion criteria
 Presence AAA and/or BMI ≥ 27
 Midline laparotomy
 Follow up
 Physical examination
 Radiological examination
 Statistical analysis
 Bonferroni correction: p=0.05/3 = 0.017
PRISMA Flow diagram
Included patients, n = 480
- AAA, n = 150
- BMI ≥ 27, n = 330
Total # of patients excluded, n = 18
- No midline incision, n = 8
- Withdrew informed consent, n = 3
- Already incisional hernia present, n = 3
- Other, n = 4
Total number of included patients
(n = 498)
PS, n = 107
-AAA, n = 37
-BMI ≥ 27 = 70
Lost to FU/missing: 13
OMA, n = 188
-AAA, n = 61
-BMI ≥ 27 = 127
Lost to FU/missing: 18
SMA, n = 185
- AAA, n = 52
- BMI ≥ 27 = 133
Lost to FU/missing: 21
Long-term results
 Incidence incisional hernia
 In total: 92 (19%)
 Per group:
 Mean FU: 21 months (SD ± 9)
No incisional hernia Incisional hernia %
PS 62 32 30%
Onlay 145 25 13%
Sublay 130 34 18%
Long-term results
Incidence (%) Odds ratio (95% CI) P-value
OMR vs. PS 13 vs. 30 0.37 (0.20-0.69) <0.001
SMR vs. PS 18 vs. 30 0.55 (0.30-1.00) 0.05
Long-term results
Incidence (%) Odds ratio (95% CI) P-value
OMR vs. PS 13 vs. 30 0.37 (0.20-0.69) <0.001
SMR vs. PS 18 vs. 30 0.55 (0.30-1.00) 0.05
Postoperative complications
PS OMR SMR p-value
SSI (%)
Deep
Superficial
Intra-abdominal
4
2
8
7
7
4
5
4
2
NS
NS
NS
Seroma (%) 5 18 7 0.002 *
Mesh infections (%) - 3 1 NS
Mesh removal
Complete
Partial
Re-implantation
-
-
-
4
2
2
3
1
3
NS
NS
NS
Hematomas (%) 1 6 5 NS
Ileus (%) 3 6 6 NS
Re-intervention (%) 11 18 16 NS
Re-admission (%) 11 20 15 NS
* p-value: OMA vs. PS and OMA vs. SMA
Type of mesh?
Permanent vs. Absorbable
Surgical technique
In general
 (light-weight) polypropylene mesh
 Overlap: 3 centimetres
 Fixation mesh with fibrin sealant or rapid absorbable sutures
 Closure of midline fascia with running, slowly absorbable suture
 SL: WL 4:1
Mesh prophylaxis
 When?
 Midline laparotomy
 Elective procedures
 High risk groups: AAA, morbid obesity
 How?
 Polypropylene mesh
 Onlay vs. sublay
Small bites technique - Background
Current guidelines
STITCH trial
Suture Techniques to reduce the Incidence of The inCisional Hernia
 Multicenter RCT
 The Netherlands
 10 hospitals
First inclusion: October 2009
Last inclusion: February 2012
Randomization
Continuous running suture; SL:WL ≥ 4:1
2 sutures knot middle
Large bites:
 Mass closure technique, PDS plus loop 1
 Stitch every 1 centimeter
 Tissue bite >1cm
Small bites:
 Approximation fascia, PDS plus 2-0
 Stitch every 0.5 cm
 Tissue bite 0.5-1cm
Methods
 Inclusion criteria:
 Age > 18 years
 Midline laparotomy
 Elective surgery
 Follow up:
 1 month and 1 year post-operative
 Physical and radiological examination
Outcome
Primary outcome:
 Incisional hernia after 1 year follow-up
Secondary outcomes:
 Surgical Site Infection
 Burst Abdomen
 Post operative pain (VAS)
 Quality of life (SF-36 and EuroQol-5D)
PRISMA Flow diagram
Randomized (n=560)
Exclusion (n=49)
- Not meeting inclusion criteria (n=20)
- Withdraw consent (n=3)
- Perioperative death (n=2)
- Other (n=24)
Assessed for eligibility (n=609)
Large bites
N=284
Small bites
N = 276
Suture technique
Large bites Small bites p
Length incision (cm) 22 22 0.98
Number sutures 25 45 <0.001
Length used sutures (cm) 95 110 <0.001
Suture length /
Wound length (SL:WL
ratio)
4.37 5.03 <0.001
Closure time (min) 10 14 <0.001
Skin closure
 Staples
 Intracutaneous suture
36
64
40
60
0.49
Postoperative complications
Large bites Small bites p
Admission (days) 14 15 0.58
Overall complications
(%)
45 45 1.00
 Pneumonia (%) 14 12 0.71
 Ileus (%) 11 10 0.59
 SSI (%) 23 20 0.20
 Burst abdomen (%) 0.7 1.4 0.746
Long-term results
Follow-up: median 12 months (range 1-36 months)
Incidence of incisional hernia:
 Large bites group: 23% (95% CI 17-30%)
 Small bites group: 14% (95% CI 9-20%) p=0.01
Small bites technique
 When?
 Midline laparotomy
 Elective procedures
 How?
 Single layer suture
 Small needle
 Continuous small bites suture technique: stitch every 5 mm
 Aponeurosis only
Conclusion
How to prevent incisional hernia?
 Place of incision
 Closing may need closure team
 Suture technique SL:WL ratio > 4:1
 Suture technique: small bites
 Do not use rapidly absorbable sutures
 Continuous suturing technique
 Single layer aponeurotic closure
 OMR: potential to become the standard treatment in high-risk groups
Future perspectives
 Adapt current EHS guidelines
 Implementation in daily surgical practice
 Randomized controlled trial: small bites technique and prophylactic
mesh reinforcement
Thank you for your attention

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MESH inguinal hernia in the new era of patient

  • 1. Incisional hernia prevention An Jairam REPAIR research group 15th of June 2018
  • 3. Introduction Incisional hernia  Most frequent postoperative complication  Incidence general population: 10-20%  Incidence high risk groups: > 30% >>> Prevention
  • 4. Prevention of incisional hernia Prophylactic mesh reinforcement – PRIMA trial Small bites technique – STITCH trial
  • 5. Profylactic mesh reinforcement  1995, first study  Studies 1998 - 2015  Small patient numbers  Mesh position: unclear  Postoperative complications: unclear
  • 6. Current guidelines ‘Larger trials are needed to make a strong recommendation to perform prophylactic mesh augmentation for all patients within a certain risk group’
  • 8. Randomization 1) Primary Suture  Hechten van de fascie 2) Onlay mesh reinforcement 3) Sublay mesh reinforcement
  • 9. Endpoints  Primary endpoint  Incisional hernia incidence after 2 years follow-up  Secondary endpoints  Postoperative complications  Quality of Life (EuroQoL-5D, SF-36)  Pain  Cost-effectiveness
  • 10. Methods  Inclusion criteria  Presence AAA and/or BMI ≥ 27  Midline laparotomy  Follow up  Physical examination  Radiological examination  Statistical analysis  Bonferroni correction: p=0.05/3 = 0.017
  • 11. PRISMA Flow diagram Included patients, n = 480 - AAA, n = 150 - BMI ≥ 27, n = 330 Total # of patients excluded, n = 18 - No midline incision, n = 8 - Withdrew informed consent, n = 3 - Already incisional hernia present, n = 3 - Other, n = 4 Total number of included patients (n = 498) PS, n = 107 -AAA, n = 37 -BMI ≥ 27 = 70 Lost to FU/missing: 13 OMA, n = 188 -AAA, n = 61 -BMI ≥ 27 = 127 Lost to FU/missing: 18 SMA, n = 185 - AAA, n = 52 - BMI ≥ 27 = 133 Lost to FU/missing: 21
  • 12. Long-term results  Incidence incisional hernia  In total: 92 (19%)  Per group:  Mean FU: 21 months (SD ± 9) No incisional hernia Incisional hernia % PS 62 32 30% Onlay 145 25 13% Sublay 130 34 18%
  • 13. Long-term results Incidence (%) Odds ratio (95% CI) P-value OMR vs. PS 13 vs. 30 0.37 (0.20-0.69) <0.001 SMR vs. PS 18 vs. 30 0.55 (0.30-1.00) 0.05
  • 14. Long-term results Incidence (%) Odds ratio (95% CI) P-value OMR vs. PS 13 vs. 30 0.37 (0.20-0.69) <0.001 SMR vs. PS 18 vs. 30 0.55 (0.30-1.00) 0.05
  • 15. Postoperative complications PS OMR SMR p-value SSI (%) Deep Superficial Intra-abdominal 4 2 8 7 7 4 5 4 2 NS NS NS Seroma (%) 5 18 7 0.002 * Mesh infections (%) - 3 1 NS Mesh removal Complete Partial Re-implantation - - - 4 2 2 3 1 3 NS NS NS Hematomas (%) 1 6 5 NS Ileus (%) 3 6 6 NS Re-intervention (%) 11 18 16 NS Re-admission (%) 11 20 15 NS * p-value: OMA vs. PS and OMA vs. SMA
  • 16. Type of mesh? Permanent vs. Absorbable
  • 17. Surgical technique In general  (light-weight) polypropylene mesh  Overlap: 3 centimetres  Fixation mesh with fibrin sealant or rapid absorbable sutures  Closure of midline fascia with running, slowly absorbable suture  SL: WL 4:1
  • 18. Mesh prophylaxis  When?  Midline laparotomy  Elective procedures  High risk groups: AAA, morbid obesity  How?  Polypropylene mesh  Onlay vs. sublay
  • 19. Small bites technique - Background
  • 21. STITCH trial Suture Techniques to reduce the Incidence of The inCisional Hernia  Multicenter RCT  The Netherlands  10 hospitals First inclusion: October 2009 Last inclusion: February 2012
  • 22. Randomization Continuous running suture; SL:WL ≥ 4:1 2 sutures knot middle Large bites:  Mass closure technique, PDS plus loop 1  Stitch every 1 centimeter  Tissue bite >1cm Small bites:  Approximation fascia, PDS plus 2-0  Stitch every 0.5 cm  Tissue bite 0.5-1cm
  • 23. Methods  Inclusion criteria:  Age > 18 years  Midline laparotomy  Elective surgery  Follow up:  1 month and 1 year post-operative  Physical and radiological examination
  • 24. Outcome Primary outcome:  Incisional hernia after 1 year follow-up Secondary outcomes:  Surgical Site Infection  Burst Abdomen  Post operative pain (VAS)  Quality of life (SF-36 and EuroQol-5D)
  • 25. PRISMA Flow diagram Randomized (n=560) Exclusion (n=49) - Not meeting inclusion criteria (n=20) - Withdraw consent (n=3) - Perioperative death (n=2) - Other (n=24) Assessed for eligibility (n=609) Large bites N=284 Small bites N = 276
  • 26. Suture technique Large bites Small bites p Length incision (cm) 22 22 0.98 Number sutures 25 45 <0.001 Length used sutures (cm) 95 110 <0.001 Suture length / Wound length (SL:WL ratio) 4.37 5.03 <0.001 Closure time (min) 10 14 <0.001 Skin closure  Staples  Intracutaneous suture 36 64 40 60 0.49
  • 27. Postoperative complications Large bites Small bites p Admission (days) 14 15 0.58 Overall complications (%) 45 45 1.00  Pneumonia (%) 14 12 0.71  Ileus (%) 11 10 0.59  SSI (%) 23 20 0.20  Burst abdomen (%) 0.7 1.4 0.746
  • 28. Long-term results Follow-up: median 12 months (range 1-36 months) Incidence of incisional hernia:  Large bites group: 23% (95% CI 17-30%)  Small bites group: 14% (95% CI 9-20%) p=0.01
  • 29. Small bites technique  When?  Midline laparotomy  Elective procedures  How?  Single layer suture  Small needle  Continuous small bites suture technique: stitch every 5 mm  Aponeurosis only
  • 30. Conclusion How to prevent incisional hernia?  Place of incision  Closing may need closure team  Suture technique SL:WL ratio > 4:1  Suture technique: small bites  Do not use rapidly absorbable sutures  Continuous suturing technique  Single layer aponeurotic closure  OMR: potential to become the standard treatment in high-risk groups
  • 31. Future perspectives  Adapt current EHS guidelines  Implementation in daily surgical practice  Randomized controlled trial: small bites technique and prophylactic mesh reinforcement
  • 32. Thank you for your attention

Editor's Notes

  • #22: Improvements to Israelsson: - Standardized suture technique - Radomisation by computer, stratification between participating hospitals en surgeons/residence closing the fascia
  • #24: Improvement compared to Israelsson: Radiological examination: ultrasonography during follow-up (and CT’s made for clinical indications) which considered the following predefined, potential predictors of incisional hernia:
  • #27: SSI overall did not differ, also when subdividing in superficial, deep or organ SSI no difference