Randomized clinical trial of laparoscopic versus open appendicectomy A. G. Pedersen, O. B. Petersen, P. Wara, H. Rùnning, N. Qvist* and S. Laurberg Departments of Surgery, Aarhus University Hospital, Aarhus and *Odense University Hospital, Odense, Denmark Correspondence to: Dr A. G. Pedersen, Hùjager 98, DK-7300 Jelling, Denmark e-mail: a.gorm@dadlnet.dk) Background: Laparoscopy in patients with a clinical suspicion of acute appendicitis has not gained wide acceptance, and its use remains controversial. Methods: In a randomized controlled trial of laparoscopic versus open appendicectomy, 583 of 828 consecutive patients consented to participate. Three hundred and one patients were allocated to open appendicectomy and 282 patients to laparoscopy, 65 of whom required conversion to open appendicectomy. Length of stay in hospital was the primary endpoint, while operating time, postoperative morbidity, duration of convalescence and cosmesis were secondary endpoints. Results: Intention-to-treat analysis revealed an equally short hospital stay in the two groups median 2 days). The median time to return to normal activity 7 versus 10 days) and work 10 versus 16days) was signi®cantly shorter following laparoscopy. Laparoscopy was associated with fewer wound infections P < 0´03) and improved cosmesis P < 0´001), but the operating time was longer 60 versus 40min). Laparoscopy was associated with more intraperitoneal abscesses 5 versus 1 per cent) but, adjusted for a greater number of gangrenous or perforated appendices in this group, the difference failed to reach statistical signi®cance. Conclusion: Hospital stay was equally short, whereas laparoscopic appendicectomy was associated with fewer wound infections, faster recovery, earlier return to work and improved cosmesis. Paper accepted 22 August 2000 British Journal of Surgery 2001, 88, 200±205 Introduction Laparoscopic appendicectomy has been shown to be both feasible and safe in randomized comparisons with open appendicectomy. In addition to improved diagnostic accuracy, laparoscopic appendicectomy confers advantages to the patient in terms of fewer wound infections 1±4 , less pain 1±9 , faster recovery and earlier return to work 2±6,8,9,10±13 . However, laparoscopic appendicectomy is more time consuming 3±6,8,9,11,12,14±16 and is associated with increased hospital costs 13 . It has been argued that the advantages of laparoscopic appendicectomy achieved by experienced laparoscopic surgeons are marginal compared with open appendicectomy, which can also be performed by surgeons in training through a short, cosmetically accep- table incision with minimal complications and a short hospital stay. Following a calculation of sample size based on the results of a pilot study, a randomized trial was undertaken to compare the outcome of laparoscopic appendicectomy with that of open appendicectomy performed out of hours by surgeons of comparable experience trainees and senior registrars on duty) designated before randomization. This was based on the hypothesis that laparoscopic appendi- cectomy would prove superior to open appendicectomy in terms of hospital stay primary endpoint), with operating time, postoperative morbidity, cosmesis and time to resume normal activity and work as secondary endpoints. Patients and methods Over 19 months, 828 consecutive patients with a clinical diagnosis of acute appendicitis, in the absence of contra- indications to creation of a carbon dioxide pneumoper- itoneum, were included in the study. At one of three participating departments in two university hospitals, patients below 15 years of age were also included. Two hundred and forty-®ve patients were not randomized Table1) and underwent a conventional open appendicect- omy, but were included in the analysis. Five hundred and eighty-three patients consented to randomization Table2). Patients were strati®ed by age and Randomized clinical trial 200 ã 2001 Blackwell Science Ltd British Journal of Surgery 2001, 88, 200±205