Tension-free inguinal hernia repair: The design of a trial to compare open and laparoscopic surgical techniques

Leigh Neumayer, Olga Jonasson, Robert Joseph Fitzgibbons, William Henderson, James Gibbs, C. James Carrico, Kamal Itani, Lawrence Kim, Theodore Pappas, Domenic Reda, Dorothy Dunlop, Martin McCarthy, Denise Hynes, Anita Giobbie-Hurder, Martin J. London, Stephanie Hatton-Ward

Research output: Contribution to journalArticle

39 Citations (Scopus)

Abstract

BACKGROUND: Inguinal hernia is a common condition in men and represents a large component of health-care expenditures. Approximately 700,000 herniorrhaphies are performed each year in the United States. The most effective method of repair of an inguinal hernia is not known. STUDY DESIGN: A multicenter, randomized, clinical trial was designed to compare open tension-free inguinal hernia repair with laparoscopic tension-free repair on recurrence rates, complications, patientcentered outcomes, and cost. The study design called for randomization of 2,200 men over a period of 3 years. These men will be followed for a minimum of 2 years. This will allow determination of as little as a 3% absolute difference in recurrence rates with 80% power. Randomization is stratified by hospital, whether the hernia is unilateral or bilateral and whether the hernia is primary or recurrent. RESULTS: This is a report of the study design and current status. The study involves 14 Veterans Affairs medical centers with previous experience in laparoscopic hernia repair. After 35 months of enrollment, 2,165 men were randomized and recruitment was then closed. The majority of the patients (82.3%) had unilateral hernias and 90.6% of the hernias were primary. Sixty-seven percent of the patients had an outpatient operation. CONCLUSIONS: We report successful recruitment into a large multicenter trial comparing open and laparoscopic hernia repair. When followup is complete, this study will provide data regarding both clinical (recurrence rates) and patient-centered outcomes.

Original languageEnglish
Pages (from-to)743-752
Number of pages10
JournalJournal of the American College of Surgeons
Volume196
Issue number5
DOIs
StatePublished - May 1 2003

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Inguinal Hernia
Herniorrhaphy
Hernia
Random Allocation
Recurrence
Veterans
Health Expenditures
Multicenter Studies
Outpatients
Randomized Controlled Trials
Delivery of Health Care
Costs and Cost Analysis

All Science Journal Classification (ASJC) codes

  • Surgery

Cite this

Tension-free inguinal hernia repair : The design of a trial to compare open and laparoscopic surgical techniques. / Neumayer, Leigh; Jonasson, Olga; Fitzgibbons, Robert Joseph; Henderson, William; Gibbs, James; Carrico, C. James; Itani, Kamal; Kim, Lawrence; Pappas, Theodore; Reda, Domenic; Dunlop, Dorothy; McCarthy, Martin; Hynes, Denise; Giobbie-Hurder, Anita; London, Martin J.; Hatton-Ward, Stephanie.

In: Journal of the American College of Surgeons, Vol. 196, No. 5, 01.05.2003, p. 743-752.

Research output: Contribution to journalArticle

Neumayer, L, Jonasson, O, Fitzgibbons, RJ, Henderson, W, Gibbs, J, Carrico, CJ, Itani, K, Kim, L, Pappas, T, Reda, D, Dunlop, D, McCarthy, M, Hynes, D, Giobbie-Hurder, A, London, MJ & Hatton-Ward, S 2003, 'Tension-free inguinal hernia repair: The design of a trial to compare open and laparoscopic surgical techniques', Journal of the American College of Surgeons, vol. 196, no. 5, pp. 743-752. https://doi.org/10.1016/S1072-7515(03)00004-8
Neumayer, Leigh ; Jonasson, Olga ; Fitzgibbons, Robert Joseph ; Henderson, William ; Gibbs, James ; Carrico, C. James ; Itani, Kamal ; Kim, Lawrence ; Pappas, Theodore ; Reda, Domenic ; Dunlop, Dorothy ; McCarthy, Martin ; Hynes, Denise ; Giobbie-Hurder, Anita ; London, Martin J. ; Hatton-Ward, Stephanie. / Tension-free inguinal hernia repair : The design of a trial to compare open and laparoscopic surgical techniques. In: Journal of the American College of Surgeons. 2003 ; Vol. 196, No. 5. pp. 743-752.
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AU - Henderson, William

AU - Gibbs, James

AU - Carrico, C. James

AU - Itani, Kamal

AU - Kim, Lawrence

AU - Pappas, Theodore

AU - Reda, Domenic

AU - Dunlop, Dorothy

AU - McCarthy, Martin

AU - Hynes, Denise

AU - Giobbie-Hurder, Anita

AU - London, Martin J.

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N2 - BACKGROUND: Inguinal hernia is a common condition in men and represents a large component of health-care expenditures. Approximately 700,000 herniorrhaphies are performed each year in the United States. The most effective method of repair of an inguinal hernia is not known. STUDY DESIGN: A multicenter, randomized, clinical trial was designed to compare open tension-free inguinal hernia repair with laparoscopic tension-free repair on recurrence rates, complications, patientcentered outcomes, and cost. The study design called for randomization of 2,200 men over a period of 3 years. These men will be followed for a minimum of 2 years. This will allow determination of as little as a 3% absolute difference in recurrence rates with 80% power. Randomization is stratified by hospital, whether the hernia is unilateral or bilateral and whether the hernia is primary or recurrent. RESULTS: This is a report of the study design and current status. The study involves 14 Veterans Affairs medical centers with previous experience in laparoscopic hernia repair. After 35 months of enrollment, 2,165 men were randomized and recruitment was then closed. The majority of the patients (82.3%) had unilateral hernias and 90.6% of the hernias were primary. Sixty-seven percent of the patients had an outpatient operation. CONCLUSIONS: We report successful recruitment into a large multicenter trial comparing open and laparoscopic hernia repair. When followup is complete, this study will provide data regarding both clinical (recurrence rates) and patient-centered outcomes.

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