Study design
hernia, hernias
SEPARATION, CROSS
We conducted a multicenter parallel randomized controlled open-label trial comparing the short- and long-term outcomes of conventional open and laparoscopic surgery for incisional hernia repair. A complete overview of the study protocol has been published previously [Patients were enrolled at the outpatient clinic of six hospitals in The Netherlands (Amsterdam University Medical Center, Medical Center Leeuwarden, Northwest Clinics, Red Cross Hospital, Slotervaart Medical Center, Dijklander Hospital). The participating centers comprised two surgeons per center being hernia experts responsible for enrolling, randomizing, and operating patients. Approval was obtained of the Medical Ethical Committee in all participating hospitals. Informed written consent was obtained from all the patients before inclusion in the trial. An independent data and safety monitoring board was not installed, since both surgical repair methods had proven to be safe.Randomization was performed using a computer-generated program. Eligible patients were randomly assigned in a 1:1 ratio to undergo open or laparoscopic repair. An internet application allowed central randomization.The employed open repair method was at the discretion of the participating surgeon. Onlay, sublay as well as component separation technique were allowed as long as a mesh was used with an overlap of at least 5 cm. Laparoscopic repair of incisional hernias entailed employment of a mesh intraperitoneal with an overlap of the defect of 3 to 5 cm. The choice for sutures or tackers, the exact fixation repair method, and closure of the fascia defect were at the discretion of the surgeon. Postoperatively, details of the surgical repair method were entered in an online database.