Inguinal Hernia
Conditions
Keywords
inguinal hernia, asymptomatic, watchful waiting, tension-free hernia repair
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREwatchful waiting or tension-free hernia repair
Sponsors
Creighton University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
men 18 years of age and older with asymptomatic or minimally symptomatic inguinal hernias who give informed consent to be randomized. \-
Exclusion criteria
Presence of pain limiting usual activities, difficulty in reducing hernia within last 6 weeks, undetectable hernias, local or systemic infection, ASA physical status \>3, or participation in another clinical trial. \-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain limiting usual activities at two years. | — |
| Physical function (PCS) at two years. | — |
Secondary
| Measure | Time frame |
|---|---|
| Complications | — |
| patient-reported outcomes of pain, functional status, activity levels, and satisfaction with care. | — |
| Cost effectiveness. | — |
Countries
United States
Outcome results
None listed