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

Creighton University1 site in 1 country724 target enrollmentFebruary 1999

ConditionsInguinal Hernia

Overview

Phase: N/A
Intervention: Not specified
Conditions: Inguinal Hernia
Sponsor: Creighton University
Enrollment: 724
Locations: 1
Primary Endpoint: Pain limiting usual activities at two years.
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

February 1999

End Date

February 2005

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

Creighton University

Responsible Party

Sponsor

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.