A Global Prospective Cohort Study on Outcomes of Appendicectomy for Appendicitis

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Procedure
Study Type: Observational
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
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• Age: There are no age restrictions, although, if appropriate participating hospitals can choose to only include children or only adults, based on an age cut-off of their choice.

• Procedure: All patients undergoing appendicectomy for suspected or confirmed appendicitis by any surgical approach should be included. This includes patients who went theatre with suspect appendicitis even if the intraoperative or pathology results found a different diagnosis, so long as an appendicectomy was performed. It also includes patients who went to theatre for reasons other than suspected appendicitis but were found to have appendicitis intraoperatively and underwent appendicectomy. This includes interval appendicectomy and right hemicolectomy if performed for acute appendicitis.

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

Locations
Other Locations
Benin
University of Abomey Calavi
NOT_YET_RECRUITING
Cotonou
Ghana
Tamale Teaching Hospital
RECRUITING
Tamale
India
Christian Medical College and Hospital Ludhiana
NOT_YET_RECRUITING
Ludhiana
Mexico
Hospital Espanol Veracruz
RECRUITING
Veraruz
Nigeria
Lagos University Teaching Hospital
RECRUITING
Lagos
Rwanda
University Teaching Hospital of Kigali (CHUK)
NOT_YET_RECRUITING
Kigali
South Africa
Chris Hani Baragwanath Academic Hospital
RECRUITING
Johannesburg
Contact Information
Primary
Teddy Anyomih
t.t.k.anyomih@bham.ac.uk
+441214143344
Backup
Rachel Lillywhite
r.e.lillywhite@bham.ac.uk
Time Frame
Start Date: 2025-02-03
Estimated Completion Date: 2025-12
Participants
Target number of participants: 14000
Treatments
Appendicectomy for suspected or confirmed appendicitis
All patients undergoing appendicectomy for suspected or confirmed appendicitis by any surgical approach should be included. This includes patients who went theatre with suspect appendicitis even if the intraoperative or pathology results found a different diagnosis, so long as an appendicectomy was performed. It also includes patients who went to theatre for reasons other than suspected appendicitis but were found to have appendicitis intraoperatively and underwent appendicectomy. This includes interval appendicectomy and right hemicolectomy if performed for acute appendicitis.~There are no age restrictions, although, if appropriate participating hospitals can choose to only include children or only adults, based on an age cut-off of their choice.
Sponsors
Collaborators: WITS Health Consortium (South Africa), Christian Medical College and Hospital, Ludhiana, India, Hospital Español Veracruz, Lagos University Teaching Hospital (LUTH), Ministry of Health, Ghana, Kigali University Teaching Hospital, University of Abomey Calavi, Benin
Leads: University of Birmingham

This content was sourced from clinicaltrials.gov