BACKGROUND: Inguinal hernia is a common condition in men and represents a large component of health-care expenditures. Approximately 700,000 herniorrhaphies are performed each year in the United States. The most effective method of repair of an inguinal hernia is not known. STUDY DESIGN: A multicenter, randomized, clinical trial was designed to compare open tension-free inguinal hernia repair with laparoscopic tension-free repair on recurrence rates, complications, patient-centered outcomes, and cost. The study design called for randomization of 2,200 men over a period of 3 years. These men will be followed for a minimum of 2 years. This will allow determination of as little as a 3% absolute difference in recurrence rates with 80% power. Randomization is stratified by hospital, whether the hernia is unilateral or bilateral and whether the hernia is primary or recurrent. RESULTS: This is a report of the study design and current status. The study involves 14 Veterans Affairs medical centers with previous experience in laparoscopic hernia repair. After 35 months of enrollment, 2,165 men were randomized and recruitment was then closed. The majority of the patients (82.3%) had unilateral hernias and 90.6% of the hernias were primary. Sixty-seven percent of the patients had an outpatient operation. CONCLUSIONS: We report successful recruitment into a large multicenter trial comparing open and laparoscopic hernia repair. When followup is complete, this study will provide data regarding both clinical (recurrence rates) and patient-centered outcomes.
RCT Entities:
BACKGROUND: Inguinal hernia is a common condition in men and represents a large component of health-care expenditures. Approximately 700,000 herniorrhaphies are performed each year in the United States. The most effective method of repair of an inguinal hernia is not known. STUDY DESIGN: A multicenter, randomized, clinical trial was designed to compare open tension-free inguinal hernia repair with laparoscopic tension-free repair on recurrence rates, complications, patient-centered outcomes, and cost. The study design called for randomization of 2,200 men over a period of 3 years. These men will be followed for a minimum of 2 years. This will allow determination of as little as a 3% absolute difference in recurrence rates with 80% power. Randomization is stratified by hospital, whether the hernia is unilateral or bilateral and whether the hernia is primary or recurrent. RESULTS: This is a report of the study design and current status. The study involves 14 Veterans Affairs medical centers with previous experience in laparoscopic hernia repair. After 35 months of enrollment, 2,165 men were randomized and recruitment was then closed. The majority of the patients (82.3%) had unilateral hernias and 90.6% of the hernias were primary. Sixty-seven percent of the patients had an outpatient operation. CONCLUSIONS: We report successful recruitment into a large multicenter trial comparing open and laparoscopic hernia repair. When followup is complete, this study will provide data regarding both clinical (recurrence rates) and patient-centered outcomes.
Authors: Matthew D Barber; Kim Kenton; Nancy K Janz; Yvonne Hsu; Keisha Y Dyer; W Jerod Greer; Amanda White; Susie Meikle; Wen Ye Journal: Female Pelvic Med Reconstr Surg Date: 2012 Jul-Aug Impact factor: 2.091
Authors: Leigh A Neumayer; Atul A Gawande; Jia Wang; Anita Giobbie-Hurder; Kamal M F Itani; Robert J Fitzgibbons; Domenic Reda; Olga Jonasson Journal: Ann Surg Date: 2005-09 Impact factor: 12.969
Authors: Leo Licari; Giovanni Guercio; Sofia Campanella; Gregorio Scerrino; Sebastiano Bonventre; Roberta Tutino; Leonardo Gulotta; Giuseppe Profita; Dalila Scaturro; Giulia Letizia Mauro; Giuseppe Salamone Journal: World J Surg Date: 2019-08 Impact factor: 3.352