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

Autor: P. L. Fagniez, S. Benchetrit, C. Gouillat, J. G. Balique, M. Lepere, J. L. Bouillot, J. H. Alexandre, E. Magne, G. Mantion, J. P. Arnaud, P. Jarsaillon, J. B. Flament
Rok vydání: 2000
Předmět:
Zdroj: Hernia. 4:S10-S16
ISSN: 1248-9204
1265-4906
DOI: 10.1007/bf01387176
Popis: 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.
Databáze: OpenAIRE
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