Clinical trial NCT00263250: Watchful Waiting Versus Open Tension-free Repair of Inguinal Hernia in Asymptomatic or Minimally Symptomatic Men
Official title: Watchful Waiting Versus Open Tension-free Repair of Inguinal Hernia in Asymptomatic or Minimally Symptomatic Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inguinal Hernia
Keywords: inguinal hernia
asymptomatic
watchful waiting
tension-free hernia repair
Lead sponsor: Creighton University
Sponsor class: OTHER
First posted: 2005-12-08
Enrollment: 724
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

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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.

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Primary outcomes:
measure: Pain limiting usual activities at two years.
measure: Physical function (PCS) at two years.
Secondary outcomes:
measure: Complications
measure: patient-reported outcomes of pain, functional status, activity levels, and satisfaction with care.
measure: Cost effectiveness.
Other outcomes:
Locations:
city: Chicago
country: United States
facility: American College of Surgeons
state: Illinois
Study officials:
affiliation: American College of Surgeons
name: Olga Jonasson, M.D.
role: STUDY_DIRECTOR
References:
citation: Fitzgibbons RJ Jr, Giobbie-Hurder A, Gibbs JO, Dunlop DD, Reda DJ, McCarthy M Jr, Neumayer LA, Barkun JS, Hoehn JL, Murphy JT, Sarosi GA Jr, Syme WC, Thompson JS, Wang J, Jonasson O. Watchful waiting vs repair of inguinal hernia in minimally symptomatic men: a randomized clinical trial. JAMA. 2006 Jan 18;295(3):285-92. doi: 10.1001/jama.295.3.285.
citation: Schroeder AD, Tubre DJ, Fitzgibbons RJ Jr. Watchful Waiting for Inguinal Hernia. Adv Surg. 2019 Sep;53:293-303. doi: 10.1016/j.yasu.2019.04.014. Epub 2019 May 15. No abstract available.
citation: Ramanan B, Maloley BJ, Fitzgibbons RJ Jr. Inguinal hernia: follow or repair? Adv Surg. 2014;48:1-11. doi: 10.1016/j.yasu.2014.05.017.
citation: Fitzgibbons RJ Jr, Ramanan B, Arya S, Turner SA, Li X, Gibbs JO, Reda DJ; Investigators of the Original Trial. Long-term results of a randomized controlled trial of a nonoperative strategy (watchful waiting) for men with minimally symptomatic inguinal hernias. Ann Surg. 2013 Sep;258(3):508-15. doi: 10.1097/SLA.0b013e3182a19725.
citation: Sarosi GA, Wei Y, Gibbs JO, Reda DJ, McCarthy M, Fitzgibbons RJ, Barkun JS. A clinician's guide to patient selection for watchful waiting management of inguinal hernia. Ann Surg. 2011 Mar;253(3):605-10. doi: 10.1097/SLA.0b013e31820b04e9.