Intraperitoneal positioning of conventional parietal mesh provides efficient reconstruction but causes visceral adhesion formation in 80-100% of the cases. The purpose of this clinical trial was to assess the performance and tolerance of a new generation of polyester mesh protected by a hydrophilic resorbable film. Eighty patients were included in a prospective multicenter clinical trial. Patients were treated for ventral hernia via an open approach (64%) or laparoscopically (36%). All meshes were implanted in a midline intraperitoneal location. The main objective was to evaluate the anti-adhesive capability of the mesh in relation to the viscera. In order to assess the absence of visceral adhesion objectively, an ultrasound (US) specific examination was initially validated (pre-operative prediction vs. per-operative findings) and then used during the follow-up. The usual clinical parameters were also collected to follow the patients on a period up to 4 years. Pre-operative US prediction vs. per-operative macroscopic findings: sensitivity 79%, overall accuracy 76%, negative predictive value 85%. After 12 months, 86% of the patients were ultrasonically adhesion free. Early post-operative complications were: seroma/hematoma (16%), subcutaneous infection (4%), cutaneous necrosis (1%) and occlusions (outside the mesh) (2.5%). No mortality was reported. Clinically, after 12-month follow-up, no complication related to post-operative adhesions to the mesh was noted: (occlusion 0%, fistula 0%). Late complications were: mesh sepsis (1%), new defects (4%) and recurrence (2.5%). Finally, 56 patients (75.7%) were clinically evaluated with a mean follow-up of 48+/-6 months. One direct recurrence was noted while six patients experienced new defect outside the mesh. No long-term severe complication such as occlusion or enterocutaneous fistula was observed. Based on a mean clinical follow-up of 4 years, the results of this prospective multicenter clinical trial demonstrate the safety and the efficiency of this composite mesh in the intraperitoneal treatment of incisional and umbilical hernia. In particular there was no early or long-term main complication due to the intraperitoneal location of the mesh.

The ease of use of this device, combined with the absence of recurrence related to the investigated device and the good pain-free outcome in this group of patients confirmed the effectiveness and tolerance of the resorbable fixation concept of I-Clip(TM).

Summary: Complete and rapid cellular ingrowth is the necessary condition of an ideal parietal mesh. However, this property obtained with conventional meshes induces visceral adhesion formation in 8o to loo% of the cases when the mesh is intraperitoneally implanted. In order to combine both cellular ingrowth on one side and adhesion prevention on the other, a new generation of polyester mesh protected by a hydrophilic absorbable film has been developed. The purpose of this study was to assess the performance and tolerance of this mesh in clinical use. 80 patients (mean age: 58 + 12 )7) were included in a prospective multicenter clinical trial: 75% for incisional hernia, 25% for umbilical hernia. Patients were treated via an open approach (64%) or laparoscopically (36%). All meshes were implanted in a midline intraperitoneal location. The main outcome was to evaluate the antiadhesive capability of the mesh as regards the viscera. In order to objectively assess the absence of visceral adhesion, a specific ultrasound (US) examination was firstly validated (preoperative prediction vs. operative findings) and secondly used during follow-up as well as usual the clinical parameters. Pre-op US prediction vs. per-op macroscopic findings: sensitivity 77%, specificity 74%, overall accuracy 75%, negative predicive value 84% (probability illustrating that a negative test really identified an adhesion-free patient). After two months, 80% of the patients were ultrasonically adhesion-free (88% in the laparoscopic group, 76% in the open surgery group, 77% in the incisional hernia group, 88% in the umbilical hernia group). Early postoperative complications were: seroma/hematoma 16.25~ subcutaneous infection 3.7%, cutaneous necrosis 2.5% and obstructions (outside the mesh) z.5%. No mortality was observed. Clinically, after lo months, no complication related to postoperative adhesions to the mesh was observed: (obstruction o%, fistula or sepsis 0%). The observed recurrence rate was 2.5%. The intermediate results obtained in this prospective multicenter clinical trial demonstrated the safety and efficiency of this composite mesh in the intraperitoneal treatment of both incisional and umbilical hernia.

]Summary: A case is reported of a recurrent umbilical hernia treated using an intraperitoneal Parietex| Composite mesh through a laparoscopic approach. ~q Three trocars were inserted in the left flank. According to the size of the defects (3xscm), a 15 x locm composite mesh was selected. The edges of the defects and the shape and size of the mesh centered on the hernia were drawn on the anterior abdominal wall. A reference point was positioned 1 cm outside each angle of the mesh. After the hydrophilic and absorbable film had been hydrated, the mesh was rolled, the film inside, and introduced within the peritoneal cavity. The mesh was carefully oriented with the smooth side on the viscera, porous side towards the wall. A 2mm cutaneous incision was performed at each reference point. An absorbable suture was inserted in the cutaneous incision, routed through the wall and the mesh, and finally brought out through the same incision. Using such a method, a transparietal subcutaneous suture was obtained in each corner and the mesh could be perfectly centered on the defect. The 1 cm distance between each corner of the mesh and the emerging tip of the needle induced a moderate tension within the mesh which balanced the relaxation of the wall during the exsufflation of the pneumoperitoneum. The final fixation of the mesh was then obtained using non-absorbable metallic devices. Hospital discharge was after 2 days and the patient returned to a normal activity within to days. After a threemonth follow-up, no complication attributed to the laparoscopic approach or to the intraperJ.toneal position of the mesh had been reported.