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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Watchful Waiting Versus Open Tension-free Repair of Inguinal Hernia in Asymptomatic or Minimally Symptomatic Men|
- Pain limiting usual activities at two years.
- Physical function (PCS) at two years.
- patient-reported outcomes of pain, functional status, activity levels, and satisfaction with care.
- Cost effectiveness.
|Study Start Date:||February 1999|
|Study Completion Date:||February 2005|
|Primary Completion Date:||December 2004 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00263250
|United States, Illinois|
|American College of Surgeons|
|Chicago, Illinois, United States, 60610|
|Study Director:||Olga Jonasson, M.D.||American College of Surgeons|