Tension Free Sutureless Sublay Ventral Hernia Repair Prospective

Tension- Free Sutureless Sublay Ventral Hernia Repair 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

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

Hypothesis 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.

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

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

Material Ventral hernia with defect > 5 cm Italy Poland Russia Total Number of patients 23 7 7 37 17 F, 6 M 3 F, 4 M 5 F, 2 M 25 F, 12 M BMI 31. 6± 4. 3 33. 3 ± 6. 2 35. 6 ± 7. 5 32. 6 ± 5. 9 Age (years) 64. 2 ± 14 67. 5 ± 11 57. 8 ± 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 M 1 2 juxtaumbilical M 2 5 (13%) subumbilical M 3 5 (13%) xipho-pubic M 4 8 (21%) paramedial 1 (3%) transverse 1 (3%) lumbar 1 (3%) paracolostomic hernia 1 (3%) after appendectomy 2 (5%) Recurrent hernia mesh used before (5%) 8 (21%) 4 (10%)

Material Italy Area of defect (cm 2) W 2 - W 4 - Total 134 ± 65 109 ± 56 71± 13 117 ± 53 4 (17%) 1 (14%) 3 (42%) 8 (22%) 10 (43%) 4 (57%) 2 (29%) 16 (43%) 9 (40%) 2 (29%) 13 (35%) 23 7 7 37 5 cm<D* <10 cm W 3 - 10 cm< D* <15 cm Poland Russia D* >15 cm TOTAL * D- diameter of the defect

Methods Italy Poland Russia Antibiotics prophylactics Ceftriaxone 2. 0 g iv Kefzol & Metronidazol Cefazolin 1. 0 Thromboembolic prophylactics Fraxiparine or Clexane Elastic compression 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 Type of anesthesia

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 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 (14 x 18 cm) or Hertra O (20 x 20 cm or 30 x 30 cm) (Herniamesh, Italy)

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

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

Results Italy Poland Russia Total Area of defect (cm 2) 134 ± 65 109 ± 56 71± 13 117 ± 53 Time of operation (min) 115 ± 16 116 ± 54 71 ± 32 106 ± 32 23 ± 8 33 ± 17 21 ± 15 25 ± 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 mesh implantation* * Time of posterior fascia suturing, mesh placement and anterior fascia closure.

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

Results Italy Poland Russia Total Early complications Wound hematoma 0 0 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) Return to normal home activity 1 weeks 1 week * Pain assessed according to Visual Analogue Scale (0 -10)

Results Second follow up Italy Poland Russia Total 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 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 0 0 **Effect of surgery 4 4 (months) * 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.