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

被引：29

作者：

Balique J.G. ^{[1
]}

Benchetrit S. ^{[2
]}

Bouillot J.L. ^{[3
]}

Flament J.B. ^{[4
]}

Gouillat C. ^{[5
]}

Jarsaillon P. ^{[6
]}

Lepère M. ^{[7
]}

Mantion G. ^{[8
]}

Arnaud J.P. ^{[9
]}

Magne E. ^{[10
]}

Brunetti F. ^{[11
]}

机构：

[1] Clinique du Parc, 42270 Saint Priest en Jarez

[2] Clinique Jeanne d'Arc, 69008 Lyon

[3] Hôtel Dieu, 75004 Paris

[4] Hôpital Robert Debré, 51000 Reims, Av du Général Koenig

[5] Hôtel Dieu, 69002 Lyon

[6] Clinique du Renaison, 42300 Roanne

[7] Clinique St Charles, 85016 La Roche/Yon Cedex

[8] Hôpital Jean Minjoz, 25000 Besançon

[9] CHRU, 49100 Angers

[10] Clinique Tivoli

[11] Hôpital Henri Mondor

来源：

Hernia | 2005年 / 9卷 / 1期

关键词：

Adhesion prevention; Intraperitoneal treatment of incisional hernia; Multicenter clinical trial; Parietex composite mesh;

D O I：

10.1007/s10029-004-0300-z

中图分类号：

学科分类号：

摘要：

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. © Springer-Verlag 2004.

引用

页码：68 / 74

页数：6

共 28 条

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