Clinical trial NCT06774001: A Global Prospective Cohort Study on Outcomes of Appendicectomy for Appendicitis
Official title: A Global Prospective Cohort Study on Outcomes of Appendicectomy for Appendicitis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Appendicitis
Appendectomy
Keywords: Appendicectomy
Appendicitis
Appendectomy
Lead sponsor: University of Birmingham
Sponsor class: OTHER
Collaborators: name: Christian Medical College and Hospital, Ludhiana, India
name: Ministry of Health, Ghana
name: Lagos University Teaching Hospital (LUTH)
name: Hospital Español Veracruz
name: WITS Health Consortium (South Africa)
name: University of Abomey Calavi, Benin
name: Kigali University Teaching Hospital
First posted: 2025-01-14
Enrollment: 14000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutive patients undergoing appendicectomy for suspected or confirmed appendicitis are eligible for inclusion and should be captured in the study.

Brief 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.

Detailed description: This prospective, multicentre, global cohort study will capture patients within an overall study window of 3 February 2025 to 25 May 2025. Any hospital performing appendicectomy worldwide will be eligible to participate, collecting data over 14 days for consecutive patients undergoing appendicectomy for suspected or confirmed acute appendicitis.

The primary aim is to identify areas for system strengthening in emergency surgery using appendicitis as a tracer condition with a pre-defined key performance measurement set. The secondary aims of this study are to evaluate variations in the presentation, diagnosis, management, access to minimally invasive surgery, and outcomes of patients that have surgery for suspected acute appendicitis. Variation could be assessed across groups stratified by human development index, hospital funding, urban/rural, and facility level.

All consecutive patients undergoing appendicectomy for suspected or confirmed appendicitis are eligible for inclusion and should be captured in the study. No additional follow-up is required for this study. Follow-up data will be collected from routine health records.

Based on previous NIHR-GSU prospective cohort studies, this study is anticipated to include around 500 hospitals. Based on an average of one appendectomy per day and two 14-day data collection blocks per hospital, we anticipate capturing data for 14,000 patients.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Indication: Appendicectomy for any indication other than suspected or confirmed appendicitis should be excluded. For example, patients having appendicectomy for known appendiceal neoplasm.
* Procedure: Patients having appendectomy as part of another surgical procedure should be excluded. For example, patients having removal of appendix as part of a colon cancer procedure are not eligible for inclusion.
* Approach: Natural orifice surgery and endoscopic treatment for suspected appendicitis are excluded.
* Previous appendicectomy: Patients having surgery for stump appendicitis are excluded.
* Return to theatre: Patients should be entered into study only once. A patient returning to theatre after appendectomy should not be re-entered as a new patient.

Primary outcomes:
measure: Time from symptom onset to first assessment by the surgical team
timeFrame: Any time up to point of first assessment by surgical team
measure: Perforation rate
timeFrame: Within 30 days postoperatively
measure: Imaging
timeFrame: From presentation to time of Surgery
measure: Laparoscopy rate
timeFrame: Time from Knife to Skin to end of operation
measure: Time from first assessment to theatre
timeFrame: Time from first assessment by surgical team to knife on skin
measure: Negative appendicectomy rate
timeFrame: Within 30 days postoperatively
measure: Post-operative length of stay
timeFrame: Within 30 days postoperatively
measure: 30-day overall Clavien-Dindo complications
timeFrame: Within 30 days postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Cotonou
country: Benin
facility: University of Abomey Calavi
city: Tamale
country: Ghana
facility: Tamale Teaching Hospital
city: Ludhiana
country: India
facility: Christian Medical College and Hospital Ludhiana
city: Veraruz
country: Mexico
facility: Hospital Espanol Veracruz
city: Lagos
country: Nigeria
facility: Lagos University Teaching Hospital
city: Kigali
country: Rwanda
facility: University Teaching Hospital of Kigali (CHUK)
city: Johannesburg
country: South Africa
facility: Chris Hani Baragwanath Academic Hospital
Study officials:
affiliation: University of Birmingham
name: Aneel Bhangu
role: STUDY_DIRECTOR
References: