1. Incisional hernia prevention
An Jairam
REPAIR research group
15th of June 2018

2. Disclosure
No conflict of interest

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
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’

7. PRIMA Trial

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. Total number of included patients (n = 498)
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
0.37 ( )
<0.001
SMR vs. PS
18 vs. 30
0.55 ( )
0.05

14. Long-term results Incidence (%) Odds ratio (95% CI) P-value OMR vs. PS
0.37 ( )
<0.001
SMR vs. PS
18 vs. 30
0.55 ( )
0.05

15. Postoperative complicationsPS
OMR
SMR
p-value
SSI (%)
Deep
Superficial
Intra-abdominal 4 2 8 7 5 NS
Seroma (%) 18
0.002 *
Mesh infections (%) - 3 1
Mesh removal
Complete
Partial
Re-implantation
Hematomas (%) 6
Ileus (%)
Re-intervention (%) 11 16
Re-admission (%) 20 15
* p-value: OMA vs. PS and OMA vs. SMA

16. Permanent vs. Absorbable
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

20. Current guidelines

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
Improvements to Israelsson:
- Standardized suture technique
- Radomisation by computer, stratification between participating hospitals en surgeons/residence closing the fascia

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)
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:

25. Assessed for eligibility (n=609)
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
0.98
Number sutures 25 45
<0.001
Length used sutures (cm) 95
110
Suture length /
Wound length (SL:WL ratio)
4.37
5.03
Closure time (min) 10 14
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
1.00
Pneumonia (%) 12
0.71
Ileus (%) 11 10
0.59
SSI (%) 23 20
0.20
Burst abdomen (%)
0.7
1.4
0.746
SSI overall did not differ, also when subdividing in superficial, deep or organ SSI no difference

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. How to prevent incisional hernia?
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