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

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

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 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 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 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

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

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) 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:

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

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

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

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

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

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