Abstract
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.
Similar content being viewed by others
References
George CD, Ellis H (1986) The results of incisional hernia repair: a twelve year review. Ann R Coll Surg Engl 68:185–187
Hesselink VJ, Luijendijk RW, deWilt JH, Heide R, Jeekel J (1993) An evaluation of risk factors in incisional hernia recurrence. Surg Gynecol Obstet 176:228–234
Luijendijk RW, Hop WC, Van der Tol MP, De Lange DC, Braaksma MM, Ijzermans JN, Boelhouwer RU, De Vries BC, Salu MK, Wereldsma JC, Bruijninckx CM, Jeekel J (2000) A comparison of suture repair with mesh repair for incisional hernia. N Engl J Med 343:392–398
Rives J, Lardennois B, Pire JC, Hibon J (1973) Large incisional hernias. The importance of flail abdomen and of subsequent respiratory disorders. Chirurgie 99:547–563
Rives J, Pire JC, Flament JB, Palot JP (1987) Major incisional hernias. In: Chevrel JP (ed) Surgery of the abdominal wall. Springer, Berlin, Heidelberg, New York, pp 116–144
Benchetrit S, Debaert M, Detruit B, Dufilho A, Gaujoux D, Lagoutte J, Lepère M, Martin Saint Leon L, Pavis d’Escurac X, Rico E, Sorrentino J, Therin M (1998) Laparoscopic and open abdominal wall reconstruction using PARIETEX(r) meshes: clinical results on 2700 hernias. Hernia 2:57–62
Heniford BT, Park A, Ramshaw BJ, Voeller G (2000) Laparoscopic ventral and incisional hernia repair in 407 patients. J Am Coll Surg 190:645–650
Le Blanc KA, Booth WV (1993) Laparoscopic repair of incisional abdominal hernias using expanded polytetrafluoroethylene: preliminary findings. Surg Laparosc Endosc 3:420–424
Amid PK, Shulman G, Lichtenstein L, Sostrin S, Young J, Hakakha M (1995) Preliminary evaluation of composite materials for the repair of incisional hernias. Ann Chir 49:539–543
Morris-Stiff G, Hughes LE (1998) The continuing challenge of parastomal hernia: failure of a novel polypropylene mesh repair. Ann R Coll Surg Engl 80:184–187
Karakousis CP, Volpe C, Tanski J, Colby ED, Winston J, Driscoll DL (1995) Use of a mesh for musculoaponeurotic defects of the abominal wall in cancer surgery and the risk of bowel fistulas. J Am Coll Surg 181:11–16
Flament JB, Avisse C, Palot JP, Delattre JF (2000) Complications in incisional hernia repairs by the placement of retromuscular prostheses. Hernia 4[Suppl]: S25–S29
Bauer JJ, Harris MT, Kreel I, Gelernt IM (1999) Twelve-year experience with expanded polytetrafluoroethylene in the repair of abdominal wall defects. Mt Sinai J Med 66:20–25
Goldberg JM, Toledo AA, Mitchell DE (1987) An evaluation of the Gore-Tex surgical membrane for the prevention of post-operative peritoneal adhesions. Obstet Gynecol 70:846–848
Le Blanc KA, Booth WV, Whitaker JM, Bellanger DE (2001) Laparoscopic incisional and ventral herniorraphy: our initial 100 patients. Hernia 5:41–45
Amid PK, Shulman AG, Lichtenstein IL, Sostrin S, Young J, Hakakha H (1994) Experimental evaluation of a new composite mesh with the selective property of incorporation to the abdominal wall without adhering to the intestines. J Biomed Mater Res 28:373–375
Bendavid R (1997) Composite mesh (polypropylene-e PTFE) in the intraperitoneal position. Hernia 1:5–8
Mutter D, Rodeheaver GT, Diemunsch P, Therin M, Moody DL, Raffaelli M, Marescaux J (1998) A new composite mesh (collagen-polyester) for intra-abdominal laparoscopic hernia repair. Surg Endosc 12:595
Arnold PB, Green CW, Foresman PA, Rodeheaver GT (2000) Evaluation of resorbable barriers for preventing surgical adhesions. Fertil Steril 73:157–161
Balique JG, Alexandre JH, Arnaud JP, Benchetrit S, Bouillot JL, Fagniez PL, Flament, JB, Gouillat C, Jarsaillon P, Lepère M, Magne E, Mantion G (2000) Intraperitoneal treatment of incisional and umbilical hernias: intermediate results of a multicenter prospective clinical trial using an innovative composite mesh. Hernia, 4[Suppl 1]: S10–S16
Sigel B, Golub RM, Loiacono LA, Parsons RE, Kodama I, Machi J, Justin J, Sachdeva AK, Zaren HA (1991) Technique of ultrasonic detection and mapping of abdominal wall adhesions. Surg Endosc 5:161–165
Arnaud JP, Cervi C, Tuech JJ, Cattan F (1997) Surgical treatment of post-operative incisional hernias by intraperitoneal insertion of a Dacron mesh. Hernia 1:97–99
Pedersen T, Eliasen K, Henriksen E (1990) A prospective study of mortality associated with anaesthesia and surgery: risk indicators of mortality in hospital. Acta Anaesthesiol Scand 34:176–182
Moreno-Egea A, Liron R, Girela E, Aguayo JL (2001) Laparoscopic repair of ventral and incisional hernia using a new composite mesh (Parietex). Surg Laparosc Endosc & Percutaneous Tech 11:103–106
Ramshaw BJ, Esartia P, Schwab J, Mason EM, Wilson RA, Duncan TD, Miller J, Lucas GW, Promes J (1999) Comparison of laparoscopic and open ventral herniorrhaphy. Am Surg 65:827–832
Oussoultzoglou E, Baulieux J, De La Roche E, Peyregne V, Adham M, Berthoux N, Ducerf C (1999) Long-term results of 186 patients with large incisional abdominal wall hernia treated by intraperitoneal mesh. Ann Chir 53:33–40
Leber GE, Garb JL, Alexander AL, Reed WP (1998) Long-term complications associated with prosthetic repair of incisional hernia. Arch Surg 133:378–382
Ramshaw B, Abiad F, Voeller G, Wilson R, Mason E (2003) Polyester (Parietex) mesh for total extraperitoneal laparoscopic inguinal hernia repair: initial experience in the United States. Surg Endosc 17:498–501
Acknowledgements
The authors would like to thank Mr. Patrice Becker-Sofradim (Trévoux) for his contribution to the coordination of this study.
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Balique, J.G., Benchetrit, S., Bouillot, J.L. et al. Intraperitoneal treatment of incisional and umbilical hernias using an innovative composite mesh: four-year results of a prospective multicenter clinical trial. Hernia 9, 68–74 (2005). https://doi.org/10.1007/s10029-004-0300-z
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s10029-004-0300-z