#Rene van der wijck trial#

Intraoperatively, acute appendicitis is classified as either simple or complex. In Northern America the estimated number of patients with appendicitis in 2015 was over 378,000. In the Netherlands, more than 12,000 patients undergo appendectomy for acute appendicitis each year. Although the role of surgery as primary treatment has recently been questioned, appendectomy remains the treatment of choice. Registered on 20 December 2016.Īcute appendicitis is one of the most common surgical emergencies in children and adults worldwide.

#Rene van der wijck trial#

Trial registrationĭutch Trial Register, NTR6128. If non-inferiority is established, longer intravenous administration following appendectomy for complex appendicitis can be abandoned, and guidelines need to be adjusted accordingly. This trial will provide evidence on whether 48 h of postoperative antibiotics is non-inferior to a standard course of 5 days of antibiotics. Both per-protocol and intention-to-treat analyses will be performed. The non-inferiority margin for the difference in the primary endpoint rate is set at 7.5% (one-sided test at ɑ 0.025). Secondary outcomes include IAA, SSI, restart of antibiotics, length of hospital stay (LOS), reoperation, percutaneous drainage, readmission rate, and cost-effectiveness. The primary outcome is a composite endpoint of infectious complications, including intra-abdominal abscess (IAA) and surgical site infection (SSI), and mortality within 90 days after appendectomy. After discharge from the hospital, patients participate in a productivity-cost-questionnaire at 4 weeks and a standardized telephone follow-up at 90 days after appendectomy. In total, 1066 patients will be randomly allocated in a 1:1 ratio to the experimental treatment arm (48 h of postoperative intravenously administered (IV) antibiotics) or the control arm (5 days of postoperative IV antibiotics). Immunocompromised or pregnant patients are excluded, as well as patients with a contraindication to the study antibiotics. Patients of 8 years and older undergoing appendectomy for acute complex appendicitis – defined as a gangrenous and/or perforated appendicitis or appendicitis in presence of an abscess – are eligible for inclusion. The aim of this study is to determine whether a short course (48 h) of postoperative antibiotics is non-inferior to current standard practice of 5 days. At the same time, the global issue of increasing antimicrobial resistance urges for optimization of antibiotic strategies. Guidelines propose 3 to 7 days of treatment, but shorter courses may be as effective in the prevention of infectious complications. There is no consensus regarding the optimum duration of antibiotics. In patients with a complex appendicitis, prolonged antibiotic prophylaxis is recommended after appendectomy. Trials volume 19, Article number: 263 ( 2018)Īcute appendicitis is one of the most common indications for emergency surgery.

Two versus five days of antibiotics after appendectomy for complex acute appendicitis (APPIC): study protocol for a randomized controlled trial