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NCT Number: NCT06774001

A Global Prospective Cohort Study on Outcomes of Appendicectomy for Appendicitis

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.

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Key information

Conditions

Appendicitis Appendectomy Cecal Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Infections Intestinal Diseases Intraabdominal Infections

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Abomey Calavi, Cotonou, Benin

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Appendicectomy

Procedure

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

Primary outcomes

  1. Time from symptom onset to first assessment by the surgical team

    Time frame: Any time up to point of first assessment by surgical team

    Duration from onset of symptoms to first assessment by the surgical team

  2. Perforation rate

    Time frame: Within 30 days postoperatively

    Proportion of all patients with histology-confirmed appendicitis who had a perforated appendix on histology

  3. Imaging

    Time frame: From presentation to time of Surgery

    Proportion of all patients having preoperative cross-sectional (CT/MRI) imaging

  4. Laparoscopy rate

    Time frame: Time from Knife to Skin to end of operation

    Proportion of all patients undergoing a laparoscopic approach for appendicectomy

  5. Time from first assessment to theatre

    Time frame: Time from first assessment by surgical team to knife on skin

    Duration from decision to operate to knife to skin

  6. Negative appendicectomy rate

    Time frame: Within 30 days postoperatively

    Proportion of all patients with a histologically normal appendix

  7. Post-operative length of stay

    Time frame: Within 30 days postoperatively

    Length of stay (in days) in hospital after appendicectomy. Day of surgery is considered day 0.

  8. 30-day overall Clavien-Dindo complications

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Rachel Lillywhite

CONTACT

[email protected]

Teddy Anyomih

CONTACT

[email protected]

+441214143344

Sponsors and collaborators

Lead sponsor

University of Birmingham

Other

Collaborators

  • Christian Medical College and Hospital, Ludhiana, India
  • Hospital Español Veracruz
  • Kigali University Teaching Hospital
  • Lagos University Teaching Hospital (LUTH)
  • Ministry of Health, Ghana
  • University of Abomey Calavi, Benin
  • WITS Health Consortium (South Africa)

Registry information

Acronym: AlliGatOr

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 14, 2025
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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