AppendicitisAlliGatOrNCT06774001
A Global Prospective Cohort Study on Outcomes of Appendicectomy for Appendicitis
An observational study of Appendicitis and Appendectomy, run by University of Birmingham at 7 sites in 7 countries.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Appendicitis, Appendectomy
- What is being tested?
- Appendicectomy
- Type of treatment
- Surgery or procedure
- How many people
- 14,000 participants
- Where
- 7 sitesin 7 countries
- Study dates
- 3 Feb 2025to Dec 2025
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All consecutive patients undergoing appendicectomy for suspected or confirmed appendicitis are eligible for inclusion and should be captured in the study.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
7 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
Rachel Lillywhite contact
7 sites in 7 countries
Benin1 site, 1 recruiting
- Not yet recruiting
University of Abomey Calavi
Cotonou
Ismail Lawani, +22967193929, ismaillawani@gmail.com
Ghana1 site, 1 recruiting
- Recruiting
Tamale Teaching Hospital
Tamale
Stephen Tabiri, +233201691005, stabiri@uds.edu.gh
India1 site, 1 recruiting
- Not yet recruiting
Christian Medical College and Hospital Ludhiana
Ludhiana
Dhruv Ghosh, +919915198894, dhruvghosh73@gmail.com
Mexico1 site, 1 recruiting
- Recruiting
Hospital Espanol Veracruz
Veraruz
Antonio Ramos, +522291204877, ramos.antonio@heveracruz.mx
Nigeria1 site, 1 recruiting
- Recruiting
Lagos University Teaching Hospital
Lagos
Adesoji Ademuyiwa, adesojiademuyiwa@yahoo.co.uk
Rwanda1 site, 1 recruiting
- Not yet recruiting
University Teaching Hospital of Kigali (CHUK)
Kigali
Faustin Ntirenganya, +250788732667, fostino21@yahoo.fr
South Africa1 site, 1 recruiting
- Recruiting
Chris Hani Baragwanath Academic Hospital
Johannesburg
Richard Crawford, +27828461559, richard.crawford@wits.ac.za
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Appendicitis, Appendectomy
- Being tested
- Appendicectomy
- Keywords
- Appendicectomy, Appendicitis, Appendectomy
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AppendicectomyProcedure or surgery
Both open and minimally invasive (laparoscopic and robotic) interventions are eligible for inclusion. Laparoscopic and robotic converted to open cases are also eligible.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Appendicectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from symptom onset to first assessment by the surgical team
Duration from onset of symptoms to first assessment by the surgical team
Measured: 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
Measured: Within 30 days postoperatively
Imaging
Proportion of all patients having preoperative cross-sectional (CT/MRI) imaging
Measured: From presentation to time of Surgery
Laparoscopy rate
Proportion of all patients undergoing a laparoscopic approach for appendicectomy
Measured: Time from Knife to Skin to end of operation
Time from first assessment to theatre
Duration from decision to operate to knife to skin
Measured: Time from first assessment by surgical team to knife on skin
Negative appendicectomy rate
Proportion of all patients with a histologically normal appendix
Measured: 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.
Measured: 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.
Measured: Within 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start3 Feb 2025
- Primary completion25 May 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AppendicitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 14,000 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Christian Medical College and Hospital, Ludhiana, India, Ministry of Health, Ghana, Lagos University Teaching Hospital (LUTH), Hospital Español Veracruz, WITS Health Consortium (South Africa), University of Abomey Calavi, Benin, Kigali University Teaching Hospital
- Responsible party
- Sponsor
- Investigators
- Aneel Bhangu, Study director, University of Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06774001
- Sponsor's protocol ID
- AL_20241016
- Acronym
- AlliGatOr
- Status last verified
- Mar 2025
- First submitted
- 8 Jan 2025
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Alligator is collecting only routinely collected hospital data, seeking to measure current clinical practice.
Publications
Anyomih TTK, Aregawi AB, Calvache JA, Dawson A, Isik A, Lapitan MC, Pata F, Qureshi AU, Zarour AMA, Bhangu A, Nepogodiev D; AlliGatOr Collaborative. Pre-hospital time and risk of perforation in patients with acute appendicitis in 112 countries (AlliGatOr): an international, prospective, observational cohort study. Lancet Glob Health. 2027 Jun 2:104015. doi: 10.1016/j.langlo.2026.104015. Online ahead of print.
PubMed 42777751
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Global Prospective Cohort Study on Outcomes of Appendicectomy for Appendicitis
- ClinicalTrials.gov ID
- NCT06774001
- Acronym / sponsor ID
- AlliGatOr / AL_20241016
- Conditions
- Appendicitis, Appendectomy
- Keywords
- Appendicectomy, Appendicitis, Appendectomy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 14,000 participants (estimated)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Collaborators
- Christian Medical College and Hospital, Ludhiana, India, Ministry of Health, Ghana, Lagos University Teaching Hospital (LUTH), Hospital Español Veracruz, WITS Health Consortium (South Africa), University of Abomey Calavi, Benin, Kigali University Teaching Hospital
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- 25 May 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 14 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Appendicectomy for suspected or confirmed appendicitis | – | Procedure: AppendicectomyAll 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All consecutive patients undergoing appendicectomy for suspected or confirmed appendicitis are eligible for inclusion and should be captured in the study.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AppendicectomyBoth open and minimally invasive (laparoscopic and robotic) interventions are eligible for inclusion. Laparoscopic and robotic converted to open cases are also eligible. | Procedure or surgery | Appendicectomy for suspected or confirmed appendicitis |
Primary outcome
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
Perforation rate
Time frame: Within 30 days postoperatively
Proportion of all patients with histology-confirmed appendicitis who had a perforated appendix on histology
Imaging
Time frame: From presentation to time of Surgery
Proportion of all patients having preoperative cross-sectional (CT/MRI) imaging
Laparoscopy rate
Time frame: 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 frame: Time from first assessment by surgical team to knife on skin
Duration from decision to operate to knife to skin
Negative appendicectomy rate
Time frame: Within 30 days postoperatively
Proportion of all patients with a histologically normal appendix
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Derived from this study: PubMed 42777751Anyomih TTK, Aregawi AB, Calvache JA, Dawson A, Isik A, Lapitan MC, Pata F, Qureshi AU, Zarour AMA, Bhangu A, Nepogodiev D; AlliGatOr Collaborative. Pre-hospital time and risk of perforation in patients with acute appendicitis in 112 countries (AlliGatOr): an international, prospective, observational cohort study. Lancet Glob Health. 2027 Jun 2:104015. doi: 10.1016/j.langlo.2026.104015. Online ahead of print.
- Individual participant dataSharing planned: No. Alligator is collecting only routinely collected hospital data, seeking to measure current clinical practice.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rachel Lillywhite contact
Aneel Bhangu study director
University of Birmingham
7 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Appendicitis and Appendectomy, run by University of Birmingham at 7 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Benin, Ghana, India, Mexico, Nigeria and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Teddy Anyomih (+441214143344, t.t.k.anyomih@bham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time from symptom onset to first assessment by the surgical team (time frame: Any time up to point of first assessment by surgical team). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06774001, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.