A Global Prospective Cohort Study on Outcomes of Appendicectomy for Appendicitis (AlliGatOr)

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.

Study Overview

• Status: Recruiting
• Conditions: Appendicitis; Appendectomy
• Intervention / Treatment: Procedure: Appendicectomy

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.

• Study Type: Observational
• Enrollment (Estimated): 14000

Contacts and Locations

• Study Contact: Name: Teddy Anyomih; Phone Number: +441214143344; Email: t.t.k.anyomih@bham.ac.uk
• Study Contact Backup: Name: Rachel Lillywhite; Email: r.e.lillywhite@bham.ac.uk

Study Locations

• Benin
  • Cotonou, Benin
    • Not yet recruiting
    • University of Abomey Calavi
    • Contact: Ismail Lawani; Phone Number: +22967193929; Email: ismaillawani@gmail.com
• Ghana
  • Tamale, Ghana
    • Recruiting
    • Tamale Teaching Hospital
    • Contact: Stephen Tabiri; Phone Number: +233201691005; Email: stabiri@uds.edu.gh
• India
  • Ludhiana, India
    • Not yet recruiting
    • Christian Medical College and Hospital Ludhiana
    • Contact: Dhruv Ghosh; Phone Number: +919915198894; Email: dhruvghosh73@gmail.com
• Mexico
  • Veraruz, Mexico
    • Recruiting
    • Hospital Espanol Veracruz
    • Contact: Antonio Ramos; Phone Number: +522291204877; Email: ramos.antonio@heveracruz.mx
• Nigeria
  • Lagos, Nigeria
    • Recruiting
    • Lagos University Teaching Hospital
    • Contact: Adesoji Ademuyiwa; Email: adesojiademuyiwa@yahoo.co.uk
• Rwanda
  • Kigali, Rwanda
    • Not yet recruiting
    • University Teaching Hospital of Kigali (CHUK)
    • Contact: Faustin Ntirenganya; Phone Number: +250788732667; Email: fostino21@yahoo.fr
• South Africa
  • Johannesburg, South Africa
    • Recruiting
    • Chris Hani Baragwanath Academic Hospital
    • Contact: Richard Crawford; Phone Number: +27828461559; Email: richard.crawford@wits.ac.za

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time from symptom onset to first assessment by the surgical team	Duration from onset of symptoms to first assessment by the surgical team	Any time up to point of first assessment by surgical team
Perforation rate	Proportion of all patients with histology-confirmed appendicitis who had a perforated appendix on histology	Within 30 days postoperatively
Imaging	Proportion of all patients having preoperative cross-sectional (CT/MRI) imaging	From presentation to time of Surgery
Laparoscopy rate	Proportion of all patients undergoing a laparoscopic approach for appendicectomy	Time from Knife to Skin to end of operation
Time from first assessment to theatre	Duration from decision to operate to knife to skin	Time from first assessment by surgical team to knife on skin
Negative appendicectomy rate	Proportion of all patients with a histologically normal appendix	Within 30 days postoperatively
Post-operative length of stay	Length of stay (in days) in hospital after appendicectomy. Day of surgery is considered day 0.	Within 30 days postoperatively
30-day overall Clavien-Dindo complications	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.	Within 30 days postoperatively

Collaborators and Investigators

• Sponsor: University of Birmingham
• Collaborators: Christian Medical College and Hospital, Ludhiana, India; Kigali University Teaching Hospital; Tamale Teaching Hospital, Ghana.; Lagos University Teaching Hospital (LUTH); Hospital Español Veracruz; University of Abomey Calavi, Benin; WITS Health Consortium (South Africa)
• Investigators: Study Director: Aneel Bhangu, University of Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2025
• Primary Completion (Estimated): May 25, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: January 8, 2025
• First Submitted That Met QC Criteria: January 8, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): April 2, 2025
• Last Update Submitted That Met QC Criteria: March 27, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Appendicitis; Appendectomy; Appendicectomy
• Additional Relevant MeSH Terms: Intestinal Diseases; Infections; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Cecal Diseases; Intraabdominal Infections; Appendicitis
• Other Study ID Numbers: AL_20241016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Alligator is collecting only routinely collected hospital data, seeking to measure current clinical practice.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No