title: Expanded clinical experience with 4DDome(R) composite prosthesis in elective open inguinal herniorrhaphy.
abstract: Prosthetic material composition is implicated in the phenomenon of postoperative chronic groin pain that has undermined elective open inguinal herniorrhaphy. Reported herein are our 'all-comers' experiences with a novel dual component mesh (4DDome(R)). A prospective cohort (Phase II) study was performed that involved all patients undergoing elective open inguinal herniorrhaphy during a four-year period. Conventional operative technique was used except for choice of prosthesis. The 4DDome mesh comprises a molded dome-shaped composite (10% polypropylene, 90% poly-L-lactic acid) with a lightweight polypropylene mesh overlay. Short- (1 week) and intermediate-term (18 months) clinical follow-up with examination and symptom questionnaire judged outcome while surgeons rated their approval using a visual analogue scale. One hundred ninety-six patients (mean age, 65.5 years; Mean BMI, 25.5; Mean ASA, 1.8, 178 males) underwent repair of 201 inguinal hernias by six surgeons (three residents). The majority of patients had an indirect hernia (n=119) 93 being combined with a posterior wall defect [Nyhus IIIa], whereas 66 had a direct hernia [Nyhus IIIb], and 11 had a recurrent hernia.) Mean operative time was 44.6 minutes with 92 patients being operated under local anesthesia. Ten patients developed seromas and two had hematomas early postoperatively. Median intermediate-term follow-up is currently 19 (range: 3-72) months for the 147 (75%) patients still available for contact. The incidence of chronic groin pain is 8.8%, whereas there has been one hernia recurrence. Surgeon satisfaction and confidence were high. The 4DDome provides appropriate clinical results and, therefore, appears valid for use in routine practice.
authors.affiliation: Department of Digestive and Endocrine Surgery, University Hospital of Strasbourg, Strasbourg, France.
authors.forename: Didier
authors.initials: D
authors.lastname: Mutter
authors.forename: Cosimo
authors.initials: C
authors.lastname: Callari
authors.forename: Jacopo
authors.initials: J
authors.lastname: D Agostino
authors.forename: Ronan A
authors.initials: RA
authors.lastname: Cahill
authors.forename: Antonello
authors.initials: A
authors.lastname: Forgione
authors.forename: Michel
authors.initials: M
authors.lastname: Vix
authors.forename: Joël
authors.initials: J
authors.lastname: Leroy
authors.forename: Jacques
authors.initials: J
authors.lastname: Marescaux
mesh_terms: D000368:Aged; D005260:Female; D006552:Hernia, Inguinal / Q000601:surgery*; D059685:Herniorrhaphy / Q000009:adverse effects / Q000379:methods; D006801:Humans; D019344:Lactic Acid; D008297:Male; D011091:Polyesters; D011108:Polymers; D011126:Polypropylenes; D013526:Surgical Mesh
chemical_list: D011091:Polyesters; D011108:Polymers; D011126:Polypropylenes; D019344:Lactic Acid; C033616:poly(lactide)