The design of an industry-sponsored randomized controlled trial to compare synthetic mesh versus biologic mesh for inguinal hernia repair

C. F. Bellows, P. P. Shadduck, W. S. Helton, Robert Joseph Fitzgibbons

Research output: Contribution to journalArticle

12 Citations (Scopus)

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 [StratticeTM Reconstructive Tissue Matrix (RTM), LifeCell, Branchburg, NJ] versus light weight, large pore polypropylene mesh (UltraProTM, 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 eVectiveness 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, thirdparty 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.

Original languageEnglish
Pages (from-to)325-332
Number of pages8
JournalHernia : the journal of hernias and abdominal wall surgery
Volume15
Issue number3
DOIs
StatePublished - Jun 2011

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Inguinal Hernia
Herniorrhaphy
Industry
Randomized Controlled Trials
Equipment and Supplies
Groin
Polypropylenes
Dermis
Activities of Daily Living
Chronic Pain
Patient Selection
Multicenter Studies
Prostheses and Implants
Cicatrix
Regeneration
Outpatients
Swine
Research Personnel
Clinical Trials
Technology

All Science Journal Classification (ASJC) codes

  • Surgery

Cite this

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title = "The design of an industry-sponsored randomized controlled trial to compare synthetic mesh versus biologic mesh for inguinal hernia repair",
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 [StratticeTM Reconstructive Tissue Matrix (RTM), LifeCell, Branchburg, NJ] versus light weight, large pore polypropylene mesh (UltraProTM, 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 eVectiveness 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, thirdparty 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.",
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T1 - The design of an industry-sponsored randomized controlled trial to compare synthetic mesh versus biologic mesh for inguinal hernia repair

AU - Bellows, C. F.

AU - Shadduck, P. P.

AU - Helton, W. S.

AU - Fitzgibbons, Robert Joseph

PY - 2011/6

Y1 - 2011/6

N2 - 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 [StratticeTM Reconstructive Tissue Matrix (RTM), LifeCell, Branchburg, NJ] versus light weight, large pore polypropylene mesh (UltraProTM, 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 eVectiveness 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, thirdparty 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.

AB - 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 [StratticeTM Reconstructive Tissue Matrix (RTM), LifeCell, Branchburg, NJ] versus light weight, large pore polypropylene mesh (UltraProTM, 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 eVectiveness 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, thirdparty 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.

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