A Global Prospective Cohort Study on Outcomes of Appendicectomy for Appendicitis

Condition(s) studied

Investigational drug(s) / intervention(s)

Appendicectomy: Both open and minimally invasive (laparoscopic and robotic) interventions are eligible for inclusion. Laparoscopic and robotic converted to open cases are also eligible.

Study summary

This study aims to assess and improve the global management of appendicitis, the most common emergency surgery, by examining various aspects of emergency care systems worldwide. Appendicitis is a time-sensitive condition, and delays in diagnosis or treatment can lead to complications, affecting patient outcomes and increasing healthcare costs. The study uses appendicitis as a "tracer condition" to explore how different healthcare systems manage emergency care, focusing on factors like access, quality, and efficiency. By gathering data from hospitals worldwide, the study seeks to identify areas where emergency surgical care can be improved, particularly in low- and middle-income countries (LMICs).

The main goal is to identify gaps in emergency care systems, using a set of key performance measures (KPMs) that assess access to care, the quality of surgical treatment, and patient safety. These include factors like the time from symptom onset to first surgical assessment, the rate of appendectomy performed via minimally invasive (laparoscopic) surgery, and postoperative complications. The study aims to collect data on at least 14,000 patients from around 500 hospitals globally between February and May 2025. The data will be analyzed by hospital income group (from low to high) to understand how different resource levels impact outcomes and to help guide future policy and practice improvements.

The study also includes two sub-studies that focus on specific issues in surgical care. The Sustainability and Waste Management sub-study aims to explore how hospitals manage waste and sustainability practices in operating theatres. This sub-study is part of global efforts to reduce carbon emissions in healthcare settings. The Financing sub-study examines the financial burden of appendicectomy, particularly the out-of-pocket costs for patients in LMICs. It will explore how the costs of open vs. laparoscopic surgery differ and investigate the impact of these costs on patients.

By combining global data on clinical outcomes with information on hospital resources and patient finances, this study hopes to provide valuable insights into how to improve emergency surgical care across diverse settings, making recommendations that can lead to better access to safe, timely, and affordable treatment for appendicitis worldwide.

Eligibility

Primary outcome measure(s)

• Time from symptom onset to first assessment by the surgical team — Any time up to point of first assessment by surgical team
  Duration from onset of symptoms to first assessment by the surgical team
• Perforation rate — Within 30 days postoperatively
  Proportion of all patients with histology-confirmed appendicitis who had a perforated appendix on histology
• Imaging — From presentation to time of Surgery
  Proportion of all patients having preoperative cross-sectional (CT/MRI) imaging
• Laparoscopy rate — Time from Knife to Skin to end of operation
  Proportion of all patients undergoing a laparoscopic approach for appendicectomy
• Time from first assessment to theatre — Time from first assessment by surgical team to knife on skin
  Duration from decision to operate to knife to skin
• Negative appendicectomy rate — Within 30 days postoperatively
  Proportion of all patients with a histologically normal appendix
• Post-operative length of stay — Within 30 days postoperatively
  Length of stay (in days) in hospital after appendicectomy. Day of surgery is considered day 0.
• 30-day overall Clavien-Dindo complications — Within 30 days postoperatively
  Adverse post-operative events may be classified in different ways: * Failure of treatment * Sequelae * Complication Definitions of these are provided in Appendix C of the study protocol.

Trial sites (7)

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