1. Safety and long-term outcome of a new concept for surgical adhesion-reduction strategies (Prevadh): a prospective, multicenter study
- Author
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Jean-Yves, Mabrut, Jean-Pierre, Favre, Bruno, Desrousseaux, Jacques, Chipponi, Jean-Pierre, Arnaud, Jacques, Domergue, J P, Duffas, Gilles, Fourtanier, Jean-Bernard, Flament, Christian, Gouillat, Stéphane, Berdah, Georges, Mantion, Pierre-Louis, Fagniez, Gérard, Champault, Jacques, Baulieux, Institut de médecine moléculaire de Rangueil (I2MR), Université Toulouse III - Paul Sabatier (UT3), Université de Toulouse (UT)-Université de Toulouse (UT)- Institut Fédératif de Recherche Bio-médicale Institution (IFR150)-Institut National de la Santé et de la Recherche Médicale (INSERM), Temps, espaces, langages Europe méridionale-Méditerranée (TELEMME), Aix Marseille Université (AMU)-Centre National de la Recherche Scientifique (CNRS), Études des Structures, des Processus d’Adaptation et des Changements de l’Espace (ESPACE), Université de la Méditerranée - Aix-Marseille 2-Université de Provence - Aix-Marseille 1-Avignon Université (AU)-Centre National de la Recherche Scientifique (CNRS)-Université de Nice Sophia-Antipolis (UNSA), Chirurgie Générale et Digestive [Purpan], Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Laboratoire de Physique des Lasers, Atomes et Molécules - UMR 8523 (PhLAM), Université de Lille-Centre National de la Recherche Scientifique (CNRS), WHO Collaborating Center on Prevention and Treatment of Human Echinococcosis, Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-IFR150-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Toulouse [Toulouse]-Hôpital Purpan [Toulouse], and CHU Toulouse [Toulouse]
- Subjects
Adult ,Male ,Time Factors ,Biocompatible Materials ,Tissue Adhesions ,MESH: Surgical Mesh ,MESH: Aged, 80 and over ,MESH: Biocompatible Materials ,Humans ,Prospective Studies ,Aged ,MESH: Treatment Outcome ,Aged, 80 and over ,MESH: Aged ,MESH: Humans ,MESH: Middle Aged ,MESH: Time Factors ,MESH: Adult ,Middle Aged ,Surgical Mesh ,MESH: Male ,MESH: Prospective Studies ,Treatment Outcome ,[SDV.SP.PHARMA]Life Sciences [q-bio]/Pharmaceutical sciences/Pharmacology ,Female ,MESH: Tissue Adhesions ,MESH: Female - Abstract
International audience; BACKGROUND/AIMS: No agent has been consistently effective in preventing formation of peritoneal adhesions and postoperative bowel obstruction after abdominal surgery. The aim of this prospective multicenter study was to assess clinical safety and efficiency of a new adhesion-reduction barrier METHODOLOGY: Between September 2000 and April 2001, Prevadh was used in 78 patients. Operative procedures included 25 hepatic resections, 7 cholecystectomies, 32 colonic resections, 7 protectomies, 3 colostomy or recovery of continuity, 1 gynaecologic surgery and 3 others. Eleven patients were operated on by laparoscopy and 67 by laparotomy. RESULTS: The overall incidence of abscesses and wound complications was 2.4% and 9% respectively. After a mean follow-up of 36 months (range: 4-51 months), no patients experienced adverse events related to the adhesion barrier. Surgical reoperative procedures were performed in 10 patients for unrelated causes and no bowel obstruction occurred within the protected area. CONCLUSIONS: This study confirmed the safety of Prevadh adhesion barrier and suggested that this resorbable barrier might provide prevention from adhesion formation on peritoneal injured surfaces. However, a large randomized controlled trial remains necessary to prove the real effectiveness of adhesion barriers on clinical long-term outcome.
- Published
- 2008