Watchful Waiting Versus Open Tension-free Repair of Inguinal Hernia in Asymptomatic or Minimally Symptomatic Men

Study Overview
=================
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.

Official Title
-----------------
Watchful Waiting Versus Open Tension-free Repair of Inguinal Hernia in Asymptomatic or Minimally Symptomatic Men

Conditions
-----------------
Inguinal Hernia

Intervention / Treatment
-----------------
* Procedure: watchful waiting or tension-free hernia repair


Participation Criteria
=================
Eligibility Criteria
-----------------
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. -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: watchful waiting or tension-free hernia repair|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain limiting usual activities at two years. |  |  | 
| Physical function (PCS) at two years. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications |  |  | 
| patient-reported outcomes of pain, functional status, activity levels, and satisfaction with care. |  |  | 
| Cost effectiveness. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
inguinal hernia, asymptomatic, watchful waiting, tension-free hernia repair