title: Multicenter prospective randomized study comparing the technique of using a bovine pericardium biological prosthesis reinforcement in parietal herniorrhaphy (Tutomesh TUTOGEN) with simple parietal herniorrhaphy, in a potentially contaminated setting.
abstract: The use of parietal synthetic prosthetic reinforcement material in potentially contaminated settings is not recommended, as there is a risk that the prosthesis may become infected. Thus, simple parietal herniorrhaphy, is the conventional treatment, even though there is a significant risk that the hernia may recur. Using new biomaterials of animal origin presently appears to offer a new therapeutic solution, but their effectiveness has yet to be demonstrated. The purpose of this multicenter prospective randomized single-blind study was to compare the surgical treatment of inguinal hernia or abdominal incisional hernia by simple parietal herniorrhaphy without prosthetic reinforcement (Group A), with Tutomesh TUTOGEN biological prosthesis reinforcement parietal herniorrhaphy (Group B), in a potentially contaminated setting. We examined early postoperative complications in the first month after the operation, performed an assessment after one year of survival without recurrence and analyzed the quality of life and pain of the patients (using SF-12 health status questionnaire and Visual Analog Pain Scale) at 1, 6, and 12 months, together with an economic impact study. Hundred and thirty four patients were enrolled between January 2009 and October 2010 in 20 French hospitals. The groups were comparable with respect to their enrollment characteristics, their history, types of operative indications and procedures carried out. At one month post-op, the rate of infectious complications (n(A) = 11(18.33%) vs. n(B) = 12(19.05%), p = 0.919) was not significantly different between the two groups. The assessment after one year of survival without recurrence revealed that survival was significantly greater in Group B (Group A recurrence: 10, Group B: 3; p = 0.0475). No difference in the patients' quality of life was demonstrated at 1, 6, or 12 months. However, at the 1 month follow-up, the "perceived health" rating seemed better in the group with Tutomesh (p = 0.022). No significant difference between the two parietal repair groups was observed during the follow-ups with respect to the criterion of pain (using a visual analog scale). There was a significant difference between the two parietal repair groups with regard to the number of days spent in intensive care unit, in favor of the Tutomesh technique (p = 0.010). The use of a Tutomesh bioprosthesis for hernia repair or postincisional hernia in a potentially contaminated workplace reduces the risk of short-term recurrence without increasing overall comorbidity.
authors.affiliation: Department of Digestive and General Surgery, University Hospital, Montpellier.
authors.forename: Marius
authors.initials: M
authors.lastname: Nedelcu
authors.affiliation: Department of Digestive and General Surgery, University Hospital, Amiens Nord.
authors.forename: Pierre
authors.initials: P
authors.lastname: Verhaeghe
authors.affiliation: Department of Digestive and General Surgery, University Hospital, Montpellier.
authors.forename: Mehdi
authors.initials: M
authors.lastname: Skalli
authors.affiliation: Department of Digestive and General Surgery, University Hospital, Bondy.
authors.forename: Gerard
authors.initials: G
authors.lastname: Champault
authors.affiliation: Department of Digestive and General Surgery, University Hospital, Bondy.
authors.forename: Christophe
authors.initials: C
authors.lastname: Barrat
authors.affiliation: Department of Digestive and General Surgery, Community Hospital, Aix en Provence.
authors.forename: Hugues
authors.initials: H
authors.lastname: Sebbag
authors.affiliation: Department of Digestive and General Surgery, University Hospital, Grenoble.
authors.forename: Fabian
authors.initials: F
authors.lastname: Reche
authors.affiliation: Department of Digestive and General Surgery, Community Hospital, Beziers.
authors.forename: Laurent
authors.initials: L
authors.lastname: Passebois
authors.affiliation: Department of Digestive and General Surgery, Community Hospital, Avignon.
authors.forename: Daniel
authors.initials: D
authors.lastname: Beyrne
authors.affiliation: Department of Digestive and General Surgery, University Hospital, Nice.
authors.forename: Jean
authors.initials: J
authors.lastname: Gugenheim
authors.affiliation: Department of Digestive and General Surgery, Hopital Nord Marseille, Marseille.
authors.forename: Stephane
authors.initials: S
authors.lastname: Berdah
authors.affiliation: Department of Digestive and General Surgery, Community Hospital, Salon de Provence, France.
authors.forename: Amine
authors.initials: A
authors.lastname: Bouayed
authors.affiliation: Department of Digestive and General Surgery, University Hospital, Montpellier.
authors.forename: Jean
authors.initials: J
authors.lastname: Michel Fabre
authors.affiliation: Department of Digestive and General Surgery, University Hospital, Montpellier.
authors.forename: David
authors.initials: D
authors.lastname: Nocca
mesh_terms: D000368:Aged; D000818:Animals; D001705:Bioprosthesis / Q000382:microbiology; D002417:Cattle; D004866:Equipment Contamination / Q000517:prevention & control*; D005260:Female; D005602:France; D006350:Heart Valve Prosthesis; D046449:Hernia, Abdominal / Q000601:surgery*; D059685:Herniorrhaphy / Q000379:methods; D006801:Humans; D008297:Male; D008875:Middle Aged; D010496:Pericardium; D011183:Postoperative Complications; D011446:Prospective Studies; D019919:Prosthesis Implantation / Q000379:methods*; D013526:Surgical Mesh; D016896:Treatment Outcome