Inguinal hernia is one of the most common worldwide afflictions of men. Because the presence of an inguinal hernia is usually considered an indication for its repair, little is known about the natural history of this abnormality in minimally symptomatic patients. Approximately 700,000 herniorrhaphies are performed in the U.S. each year, with large direct costs of surgical care and indirect costs to the economy resulting from time-off from work, school, or usual activities. The indications for surgical repair of a minimally symptomatic hernia are vague, and it is not known whether patients with inguinal hernias can safely delay surgical treatment and if they will accept Watchful Waiting (WW) as the method of management for their hernia. This multicenter collaborative project between the American College of Surgeons, Northwestern University, and the VA Cooperative Studies Program, proposes to enroll 753 men with asymptomatic or minimally symptomatic inguinal hernias, either primary or-recurrent. Patients will be recruited at 5 community and academic sites over a 2.5 year period with follow-up for a minimum of two years and an average of 3.25 years. WW will be compared with tension-free open repair (TFH). Primary outcome measurements will be: (1) Pain or discomfort limiting usual activities; (2) Changes in the Physical Component Summary score of the SF-36. Secondary outcome comparisons include cost, complications (including hernia accident and recurrence), satisfaction, and the incidence of any hernia-related operation. The role of age and comorbidity and their interactions in influencing the patient-centered outcome of hernia management will be determined. This trial will substantially increase knowledge of the natural history of inguinal hernia in men, provide useful information on medical, patient-centered, and cost outcomes of the various treatment options, and guide selection of the appropriate treatment of this common surgical disease.
|Ramanan, Bala; Maloley, Brittney J; Fitzgibbons Jr, Robert J (2014) Inguinal hernia: follow or repair? Adv Surg 48:1-11|
|Fitzgibbons Jr, Robert J; Ramanan, Bala; Arya, Shipra et al. (2013) Long-term results of a randomized controlled trial of a nonoperative strategy (watchful waiting) for men with minimally symptomatic inguinal hernias. Ann Surg 258:508-15|