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


METHODS
A multicenter, randomized, clinical trial was designed to compare open tension-free inguinal hernia repair with laparoscopic tension-free repair on recurrence rates, complications, patient-centered 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.
Neumayer
Leigh
L
VA Salt Lake City Health Care System and University of Utah Health Sciences Center, Salt Lake City, UT, USA.
Jonasson
Olga
O
Fitzgibbons
Robert
R
Henderson
William
W
Gibbs
James
J
Carrico
C James
CJ
Itani
Kamal
K
Kim
Lawrence
L
Pappas
Theodore
T
Reda
Domenic
D
Dunlop
Dorothy
D
McCarthy
Martin
M
Hynes
Denise
D
Giobbie-Hurder
Anita
A
London
Martin J
MJ
Hatton-Ward
Stephanie
S
D003365:Costs and Cost Analysis; D005500:Follow-Up Studies; D006296:Health Services / Q000706:statistics & numerical data; D006306:Health Surveys; D006552:Hernia, Inguinal / Q000601:surgery*; D006801:Humans; D010535:Laparoscopy; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000453:epidemiology; D012008:Recurrence; D012107:Research Design; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States