Biologic vs synthetic inguinal hernia repair: 1-year results of a randomized double-blinded trial

Grant V. Bochicchio, Ajay Jain, Kelly McGonigal, Douglas Turner, Obeid Ilahi, Stacey Reese, Kelly Bochicchio

Research output: Contribution to journalArticle

Abstract

Background Various surgical meshes are used in the repair of inguinal hernia and are associated with numerous complications. Our main objective in this study was to determine whether a biologic hernia matrix is equivalent to polypropylene mesh in an open inguinal hernia repair using the Lichtenstein technique. Study Design A prospective, randomized, double-blinded, single-center trial was conducted to evaluate the efficacy of a biologic Inguinal Hernia Matrix (IHM; Cook Medical) compared with polypropylene (PP) mesh using Lichtenstein's inguinal hernia repair in a 3-year outcomes study. Patients were evaluated for recurrence and complications by a blinded surgeon at 2 weeks, 3 months, 6 months, and 1 year post procedure. Patient demographics, including comorbidities and nutrition status, were recorded. Intraoperative information including hernia type and location, procedure time, level of difficulty, degree of surgeon frustration, and surgical experience were collected. Results One hundred male patients provided informed consent and were randomized into the study in a 1:1 fashion. There were no significant differences in degree of difficulty and level of frustration between the 2 groups. At 1-year follow-up, 3 recurrences were diagnosed in the IHM group as compared with none in the PP group (p = 0.11). Persistent pain trended higher in the PP group (6% vs 4%). All 3 recurrences occurred in the direct inguinal hernia group and were performed by attendings in the first year post training (3 different attendings). No recurrences occurred in patients operated on by more senior surgeons. Conclusions The IHM hernioplasty compares favorably with PP mesh at 1-year follow-up with similar recurrence rates and complications. Surgeon experience appears to be a major factor affecting successful outcomes.

Original languageEnglish (US)
Pages (from-to)751-757
Number of pages7
JournalJournal of the American College of Surgeons
Volume218
Issue number4
DOIs
StatePublished - 2014
Externally publishedYes

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Polypropylenes
Inguinal Hernia
Herniorrhaphy
Recurrence
Frustration
Hernia
Surgical Mesh
Nutritional Status
Informed Consent
Comorbidity
Demography
Outcome Assessment (Health Care)
Pain
Surgeons

ASJC Scopus subject areas

  • Surgery

Cite this

Biologic vs synthetic inguinal hernia repair : 1-year results of a randomized double-blinded trial. / Bochicchio, Grant V.; Jain, Ajay; McGonigal, Kelly; Turner, Douglas; Ilahi, Obeid; Reese, Stacey; Bochicchio, Kelly.

In: Journal of the American College of Surgeons, Vol. 218, No. 4, 2014, p. 751-757.

Research output: Contribution to journalArticle

Bochicchio, GV, Jain, A, McGonigal, K, Turner, D, Ilahi, O, Reese, S & Bochicchio, K 2014, 'Biologic vs synthetic inguinal hernia repair: 1-year results of a randomized double-blinded trial', Journal of the American College of Surgeons, vol. 218, no. 4, pp. 751-757. https://doi.org/10.1016/j.jamcollsurg.2014.01.043
Bochicchio, Grant V. ; Jain, Ajay ; McGonigal, Kelly ; Turner, Douglas ; Ilahi, Obeid ; Reese, Stacey ; Bochicchio, Kelly. / Biologic vs synthetic inguinal hernia repair : 1-year results of a randomized double-blinded trial. In: Journal of the American College of Surgeons. 2014 ; Vol. 218, No. 4. pp. 751-757.
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AU - Turner, Douglas

AU - Ilahi, Obeid

AU - Reese, Stacey

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N2 - Background Various surgical meshes are used in the repair of inguinal hernia and are associated with numerous complications. Our main objective in this study was to determine whether a biologic hernia matrix is equivalent to polypropylene mesh in an open inguinal hernia repair using the Lichtenstein technique. Study Design A prospective, randomized, double-blinded, single-center trial was conducted to evaluate the efficacy of a biologic Inguinal Hernia Matrix (IHM; Cook Medical) compared with polypropylene (PP) mesh using Lichtenstein's inguinal hernia repair in a 3-year outcomes study. Patients were evaluated for recurrence and complications by a blinded surgeon at 2 weeks, 3 months, 6 months, and 1 year post procedure. Patient demographics, including comorbidities and nutrition status, were recorded. Intraoperative information including hernia type and location, procedure time, level of difficulty, degree of surgeon frustration, and surgical experience were collected. Results One hundred male patients provided informed consent and were randomized into the study in a 1:1 fashion. There were no significant differences in degree of difficulty and level of frustration between the 2 groups. At 1-year follow-up, 3 recurrences were diagnosed in the IHM group as compared with none in the PP group (p = 0.11). Persistent pain trended higher in the PP group (6% vs 4%). All 3 recurrences occurred in the direct inguinal hernia group and were performed by attendings in the first year post training (3 different attendings). No recurrences occurred in patients operated on by more senior surgeons. Conclusions The IHM hernioplasty compares favorably with PP mesh at 1-year follow-up with similar recurrence rates and complications. Surgeon experience appears to be a major factor affecting successful outcomes.

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