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

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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 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.

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Abbreviations

FDA:

Food and Drug Administration

AAS:

Activities Assessment Scale

PRCT:

Prospective, randomized, controlled trial

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Acknowledgments

This trial was developed and funded in cooperation with LifeCell, Inc., (Branchburg, NJ). The authors have the following industry relations: C.B. and W.H. receive honoraria as consultants and lecturers for LifeCell Corporation. P.S. serves as a consultant to Allergan Medical, Ethicon Inc, Ethicon Endosurgery, LifeCell, and TransEnterix. R.F. serves as an ad hoc consultant to LifeCell and Baxter corporations, and has grant support from LifeCell (for the present study) and Biomerix Corporation (for a Phase II Trial to Determine Efficacy of a Polycarbonate, Polyurethane Biomaterial for Repair of an Inguinal Hernia), and a royalty arrangement with Cook Critical Care (for the Fitzgibbons Jenkins Catheter, a common bile duct catheter).

Author information

Authors and Affiliations

  1. Department of Surgery SL-22, Tulane University Health Sciences Center, 1430 Tulane Ave., New Orleans, LA, 70115, USA

    C. F. Bellows

  2. North Carolina Specialty Hospital and Duke University, Durham, NC, USA

    P. P. Shadduck

  3. Hospital of San Raphael, New Haven, CT, USA

    W. S. Helton

  4. Creighton University, Omaha, NE, USA

    R. J. Fitzgibbons

Authors
  1. C. F. Bellows
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  2. P. P. Shadduck
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  3. W. S. Helton
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  4. R. J. Fitzgibbons
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Corresponding author

Correspondence to C. F. Bellows.

Additional information

Trial registration: This trial has been registered at http://www.clinicaltrials.gov/. The trial registration number is NCT00681291.

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Bellows, C.F., Shadduck, P.P., Helton, W.S. et al. The design of an industry-sponsored randomized controlled trial to compare synthetic mesh versus biologic mesh for inguinal hernia repair. Hernia 15, 325–332 (2011). https://doi.org/10.1007/s10029-010-0773-x

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  • DOI: https://doi.org/10.1007/s10029-010-0773-x

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