C F Bellows1, P P Shadduck, W S Helton, R J Fitzgibbons. 1. Department of Surgery SL-22, Tulane University Health Sciences Center, 1430 Tulane Ave., New Orleans, LA 70115, USA. cbellows@tulane.edu
Abstract
PURPOSE: Biologic prostheses are designed to support tissue regeneration rather than just result in a strong scar plate, as is the case with synthetic mesh. It is not known if these newer materials will result in earlier return to normal activities and/or less post-herniorrhaphy groin pain. METHOD/STUDY DESIGN: A prospective, randomized, controlled, third-party-blinded multicenter trial was designed to compare the use of a non-cross linked porcine dermis biologic graft [Strattice(TM) Reconstructive Tissue Matrix (RTM), LifeCell, Branchburg, NJ] versus light weight, large pore polypropylene mesh (UltraPro(TM), Ethicon, Somerville, NJ). The study design called for recruitment of 170 men. These men are being followed for a minimum of 2 years. The primary aim of this study is to compare the safety and effectiveness of the two materials in a Lichtenstein inguinal hernia repair as measured by resumption of activities of daily living. Secondary outcomes include chronic pain, postoperative complications and the incidence of re-herniation at 12 and 24 months. RESULTS: This paper discusses the study design, patient recruitment and the current status of the clinical trial. The study involves nine medical centers, all with extensive experience in hernia repair. After 24 months of enrollment, 172 men were randomized and recruitment was then closed. All patients underwent elective repair of primary unilateral inguinal hernias as an outpatient operation. Follow up data are being collected. Data analyses are scheduled at 3, 12, and 24 months postoperatively. CONCLUSION: We report the design of a multi-center, third-party blinded, randomized clinical trial comparing a new surgical device with existing technology in the repair of inguinal hernias. We believe this investigator-designed and conducted trial could serve as a model for similar trials examining surgical devices performed in collaboration with industry.
RCT Entities:
PURPOSE: Biologic prostheses are designed to support tissue regeneration rather than just result in a strong scar plate, as is the case with synthetic mesh. It is not known if these newer materials will result in earlier return to normal activities and/or less post-herniorrhaphy groin pain. METHOD/STUDY DESIGN: A prospective, randomized, controlled, third-party-blinded multicenter trial was designed to compare the use of a non-cross linked porcine dermis biologic graft [Strattice(TM) Reconstructive Tissue Matrix (RTM), LifeCell, Branchburg, NJ] versus light weight, large pore polypropylene mesh (UltraPro(TM), Ethicon, Somerville, NJ). The study design called for recruitment of 170 men. These men are being followed for a minimum of 2 years. The primary aim of this study is to compare the safety and effectiveness of the two materials in a Lichtenstein inguinal hernia repair as measured by resumption of activities of daily living. Secondary outcomes include chronic pain, postoperative complications and the incidence of re-herniation at 12 and 24 months. RESULTS: This paper discusses the study design, patient recruitment and the current status of the clinical trial. The study involves nine medical centers, all with extensive experience in hernia repair. After 24 months of enrollment, 172 men were randomized and recruitment was then closed. All patients underwent elective repair of primary unilateral inguinal hernias as an outpatient operation. Follow up data are being collected. Data analyses are scheduled at 3, 12, and 24 months postoperatively. CONCLUSION: We report the design of a multi-center, third-party blinded, randomized clinical trial comparing a new surgical device with existing technology in the repair of inguinal hernias. We believe this investigator-designed and conducted trial could serve as a model for similar trials examining surgical devices performed in collaboration with industry.
Authors: J Conze; A N Kingsnorth; J B Flament; R Simmermacher; G Arlt; C Langer; E Schippers; M Hartley; V Schumpelick Journal: Br J Surg Date: 2005-12 Impact factor: 6.939
Authors: Martin McCarthy; Olga Jonasson; Chih-Hung Chang; A Simon Pickard; Anita Giobbie-Hurder; James Gibbs; Perry Edelman; Robert Fitzgibbons; Leigh Neumayer Journal: J Am Coll Surg Date: 2005-08 Impact factor: 6.113
Authors: San Keller; Carla M Bann; Sheri L Dodd; Jeff Schein; Tito R Mendoza; Charles S Cleeland Journal: Clin J Pain Date: 2004 Sep-Oct Impact factor: 3.442