Prospective Multicenter Study Preliminary Report P. Witkowski- Coordination Center Dept of Surgery, Columbia University, USA F. Abbonante- Dept of Surgery, Catanzaro Hospital, Italy Z. Sledzinski, W. Adamonis, M. Smietanski- Dept of Surgery, Medical Univ. of Gdansk, Poland I. Fedorov, L. Slavin, D. Slavin- Dept of Surgery, Medical University of Kazan, Russia Tension- Free Sutureless Sublay Ventral Hernia Repair

1. In ventral hernioplasty sutures prevent 1. In ventral hernioplasty sutures prevent  mesh migration  mesh wrinkling and curling 2. However suturing is: 2. However suturing is:  time consuming  often challenging  could create tension in the mesh resulting in o postoperative pain o complications (1,2) Backround

1. There is no need for the mesh suturing in ventral hernia repair if the mesh is rigid, macroporous, made of monofilament polypropylene, and has flat-shape memory. 2. This mesh will not migrate, wrinkle, or curl when placed in a closed space even without suturing to the surrounding tissue (3). 3. This prosthesis prevents hernia recurrence while laying flat without tension. It is held in place by intra-abdominal pressure and connective tissue ingrowth. Hypothesis

Clinical evaluation of the new Tension- Free Trabucco Ventral Hernia Repair technique, which involves the use of rigid mesh without sutures. Clinical evaluation of the new Tension- Free Trabucco Ventral Hernia Repair technique, which involves the use of rigid mesh without sutures. Aim

Prospective Multicenter Study  Coordination Center- Columbia University, USA  Participating Centers: Catanzaro Hospital, Italy Catanzaro Hospital, Italy Medical University of Gdansk, Poland Medical University of Gdansk, Poland Medical University of Kazan, Russia Medical University of Kazan, Russia  Medical treatment Preferred- general anesthesia Preferred- general anesthesia Antibiotics prophylaxis Antibiotics prophylaxis Thromboembolic disease prophylaxis Thromboembolic disease prophylaxis The same surgical technique The same surgical technique Early physical mobilization Early physical mobilization

Material Ventral hernia with defect > 5cm ItalyPolandRussiaTotal Number of patients 23 17F, 6M 7 3F, 4M 7 5F, 2M 37 25F, 12M BMI 31.6± ± ± ± 5.9 Age (years) 64.2 ± ± ± 7 63 ± 12 Incisional hernia 16 (70%) 6 (85%) 4 (57%) 26 (70%) Primary defect* 7 (30%) 1 (15%) 3 (42%) 11 (30%) *umbilical or epigastric hernia

Material Incisional hernia 26 (70%) midline incisional 20 (54%) supraumbilical M1 2 (5%) juxtaumbilical M2 5 (13%) subumbilical M3 5 (13%) 5 (13%) xipho-pubic M4 8 (21%) 8 (21%) paramedial 1 (3%) transverse lumbar paracolostomic hernia 1 (3%) after appendectomy 2 (5%) Recurrent hernia 8 (21%) mesh used before 4 (10%)

Material ItalyPolandRussiaTotal Area of defect (cm 2 ) 134 ± ± 56 71± ± 53 W2- 5cm<D * <10cm 4 (17%) 1 (14%) 3 (42%) 8 (22%) W3- 10cm< D * <15cm 10 (43%) 4 (57%) 2 (29%) 16 (43%) W4 - D * >15cm 9 (40%) 2 (29%) 13 (35%) TOTAL * D - diameter of the defect

Methods ItalyPolandRussia Antibiotics prophylactics Ceftriaxone 2.0 g iv Kefzol & Metronidazol Cefazolin 1.0 Thromboembolic prophylactics Fraxiparine or Clexane Elastic compression Type of anesthesia generalgeneral general or spinal Type of suture for posterior fascia PDS 1 Prolene 0 Vicryl 3-0/ Prolene 2-0 Type of suture for anterior fascia PDS 1 Prolene 0 Prolene 2-0

Surgical technique 1. Excision of the hernia sac 2. Closure of the peritoneum and posterior fascia with running suture 3. Placement of rigid mesh in retromuscular position or in preperitoneal space without suture 4. Closure of anterior fascia with running suture 5. Relaxing incisions of anterior fascia, if necessary 6. Redon drainage

Surgical technique 2. Closure of the peritoneum and posterior fascia with running suture

Surgical technique Surgical technique o Mesh must have proper rigidity and flat shape memory o Mesh should be macroporous, made of polypropylen and significantly larger than defect o Test for rigidity- mesh hold in upright position should not band o Mesh used in the study- Oval Patch (14x 18cm) or Hertra O (20x20cm or 30x30cm) (Herniamesh, Italy)

3. Placement of the rigid mesh in preperitoneal space or retromuscular position without suturing Surgical technique

Surgical technique Surgical technique 4. Closure of anterior fascia with running suture 4. Closure of anterior fascia with running suture 5. Relaxing incisions, if necessary to reduce tension

Results ItalyPolandRussiaTotal Area of defect (cm 2 ) 134 ± ± 56 71± ± 53 Time of operation (min) 115 ± ± ± ± 32 Time of mesh implantation* 23 ± 8 33 ± ± ± 12 Retromuscular mesh (n) 17 (74%) 5 (70%) 4 (57%) 26 (70%) Preperitoneal mesh (n) 6 (26%) 2 (30%) 3 (43%) 11 (30%) Redon applied (n) 23 (100%) 7 (100%) 5 (71%) 35 (95%) * Time of posterior fascia suturing, mesh placement and anterior fascia closure.

Results ItalyPolandRussiaTotal *VA S 1 median (min- max) 3 (1-8) 5 (3-6) 5 (2-6) 4 (1-8) TreatmentNSAIDNSAIDNSAIDNSAID Duration of treatment (days) 3 (2- 5) 4 (2-6) 5 (1-6) 3 (2-6) Duration of pain (days) 3 (1-5) 4 (2-6) 4 (1-5) 3 (1-6) Hospitalization (days) 4 (3-6) 7 (3-12) 7 (3-15) 5 (3- 15) * Pain assessed in Visual Analogue Scale (0-10) on the first day after surgery

Results ItalyPolandRussiaTotal Early complications Wound hematoma 00 1 (15%) 1 (3%) Seroma & aspiration 0 1 (15%) 0 1 (3%) Wound revision 0 1 (15%) 2 (6%) Follow up- 2 weeks after surgery *VAS 1 (0-3) 1 (0-4) 1 (0-3) 1 (0-4) Return to normal home activity 1 weeks 1 week * Pain assessed according to Visual Analogue Scale (0-10)

Results Second follow up ItalyPolandRussiaTotal Physical examination (n) Physical examination (n) 14 (61%) 6 (86%) 5 (71%) 26 (70%) Telephone call (n) 9 (39%) 1 (15%) 2 (29%) 12 (30%) Median follow up (months) 4 (1-7) 4 (1-5) 4 (1-7) 4 *Level of chronic pain 0 (0-1) 0 (0-2) 0 (0-1) 0 Recurrence rate 0000 **Effect of surgery 4444 * Level of chronic pain: 0- none, 1- temporal, 2- constant **Patient’s evaluation of the effect of operation: 4- very good, 3- good, 2- fair, 1- bad

Conclusions 1. Preliminary results of the study showed that implantation of rigid mesh with flat shape memory using the Sutureless Sublay Technique is safe and effective in the treatment of ventral abdominal hernias. 2. This technique allows surgeons to save work and time of the operation and patients are able to fast recover with low level of postoperative pain after procedure.