Intraperitoneal treatment of incisional and umbilical hernias: intermediate results of a multicenter prospective clinical trial using an innovative composite mesh

Abstract

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 80 to 100% 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 y) 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) 2.5%. No mortality was observed. Clinically, after 10 months, no complication related to postoperative adhesions to the mesh was observed: (obstruction 0%, 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.