Delayed vs. Early Appendectomy (DELAY) trial for adult patients with acute appendicitis: Study protocol for a randomized controlled trial

Abstract

IntroductionEarly appendectomy in patients diagnosed with acute appendicitis is the current standard of treatment in North America. Timely intervention is suggested to avoid the complications associated with perforated appendicitis; however, safety of nighttime operating is a competing concern, with mixed results demonstrated thus far. ObjectivesThis multi-center prospective randomized controlled trial aims to assess whether delaying appendectomy until the following morning versus early appendectomy overnight affects the rate of surgical complications in adult patients diagnosed with acute appendicitis in the evening hours. MethodsThis is a randomized, controlled trial across two academic institutions with blinded outcome assessors. Patients presenting with imaging-confirmed appendicitis with an expected appendectomy between 8 pm and 4 am and within 6 h of decision to operate will be randomized to early appendectomy (with 6 h of randomization, control arm) or delayed to the following morning (after 6 am, intervention arm). Primary outcome will be 30 day postoperative complications, defined as a composite of: mortality, readmission to hospital, emergency department visit, percutaneous drain insertion, reoperation, prolonged hospital stay (>7 days), and postoperative complications. Secondary outcome measures are operative time, length of stay, time to emergency department visit and compliance to treatment. DiscussionThis is a feasible and pragmatic clinical trial, intended to provide evidence for challenging decision making for the most common surgical disease worldwide. Results of this study will aid surgeons and health care administrators on how to appropriately triage appendectomies for patients with acute appendicitis who present overnight.