Inguinal Hernia Clinical Trial
Official title:
Watchful Waiting Versus Open Tension-free Repair of Inguinal Hernia in Asymptomatic or Minimally Symptomatic Men
This is a multicenter clinical trial to compare pain, physical function, and other outcomes in men with asymptomatic or minimally symptomatic inguinal hernias randomly assigned to watchful waiting without an operation, or a standard hernia repair with mesh. We studied the safety of delaying operation.
CONTEXT Many men with an inguinal hernia have minimal symptoms. Whether deferring operation
is safe and a good option for some patients has not been assessed.
OBJECTIVE To compare pain and the Physical Component Score (PCS) of the SF-36 at two years in
men with minimally symptomatic inguinal hernias randomized to watchful waiting (WW) or a
standard tension-free hernia repair (TFR).
DESIGN, SETTING, AND PATIENTS. Between January, 1999 and December, 2004 we conducted a
multicenter trial of 720 men (364 WW, 356 TFR) who were followed for 2-4.5 years. Men were
excluded with hernia pain interfering with activities; undetectable hernias; infection;
American Society of Anesthesiologists Physical Status >3; recent difficulty in reducing the
hernia.
INTERVENTIONS Men assigned to WW were followed at 6 months and annually and watched for
hernia symptoms. Men assigned to operation received TFR, and were followed at 3 and 6 months,
and annually.
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