Repair of ventral incisional hernia: the design of a randomized trial to compare open and laparoscopic surgical techniques.
The appearance of incisional hernia after laparotomy closure continues to be an important postoperative complication. Advances in anesthesia techniques, adequate prevention and treatment of infection during surgery, and the use of new suture materials have reduced the incidence of incisional hernia. Nevertheless, incisional hernia still occurs in 0.5% to 11% of all laparotomies performed. There are many different techniques currently in use for ventral incisional hernia (VIH) repair. Among these techniques, laparoscopic repair has been reported to be superior to open repair because of less pain, a lower recurrence rate, fewer complications, and earlier return to work. The lower rate of complications may be a major contributing factor to a reduced incidence of recurrence. However, laparoscopic repair requires expensive equipment and supplies, and it is not yet generally accepted. No conclusive randomized trial of sufficient size and power has been done to establish the "gold standard" for VIH repair, and surgeons are calling for proper evaluation. This randomized clinical trial conducted at 3 Veterans Affairs medical centers was designed to compare open VIH repair with the laparoscopic technique with respect to postoperative complications at 8 weeks, health-related quality of life, postoperative pain, time to return to normal activities, patient satisfaction, and recurrence rate of the hernia at 1 and 2 years. The study design calls for randomization of 314 men over a period of 32 months. This will allow > or =80% power to detect a 15% difference in complication rates between the 2 surgical procedures at 8 weeks. Randomization is stratified by hospital, whether the hernia is recurrent and whether the patient's body mass index is > or =35 or <35. We report the design and beginning of a multicenter trial comparing open and laparoscopic VIH repair. When completed, this study will provide surgeons and their patients with information that will help guide their choice of surgical technique.
Itani
Kamal M F
KM
Veterans Affairs Boston Health Care System, Boston and Harvard Universities, 1400 VFW Parkway, West Roxbury, Massachusetts 02132, USA. kitani@med.va.gov
Neumayer
Leigh
L
Reda
Domenic
D
Kim
Lawrence
L
Anthony
Thomas
T
D000293:Adolescent; D000328:Adult; D000465:Algorithms; D004812:Epidemiologic Methods; D006555:Hernia, Ventral / Q000601:surgery*; D006801:Humans; D010535:Laparoscopy / Q000009:adverse effects; D008297:Male; D017063:Outcome Assessment, Health Care / Q000592:standards; D011183:Postoperative Complications; D012107:Research Design / Q000592:standards*; D013514:Surgical Procedures, Operative / Q000379:methods; D016896:Treatment Outcome