A Global Prospective Cohort Study on Outcomes of Appendicectomy for Appendicitis
NCT ID: NCT06774001
Last Updated: 2025-04-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
14000 participants
OBSERVATIONAL
2025-02-03
2025-12-31
Brief Summary
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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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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Appendicectomy
Both open and minimally invasive (laparoscopic and robotic) interventions are eligible for inclusion. Laparoscopic and robotic converted to open cases are also eligible.
Interventions
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Appendicectomy
Both open and minimally invasive (laparoscopic and robotic) interventions are eligible for inclusion. Laparoscopic and robotic converted to open cases are also eligible.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
ALL
No
Sponsors
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Christian Medical College and Hospital, Ludhiana, India
OTHER
Ministry of Health, Ghana
OTHER_GOV
Lagos University Teaching Hospital (LUTH)
UNKNOWN
Hospital Español Veracruz
UNKNOWN
WITS Health Consortium (South Africa)
UNKNOWN
University of Abomey Calavi, Benin
UNKNOWN
Kigali University Teaching Hospital
OTHER
University of Birmingham
OTHER
Responsible Party
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Principal Investigators
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Aneel Bhangu
Role: STUDY_DIRECTOR
University of Birmingham
Locations
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University of Abomey Calavi
Cotonou, , Benin
Tamale Teaching Hospital
Tamale, , Ghana
Christian Medical College and Hospital Ludhiana
Ludhiana, , India
Hospital Espanol Veracruz
Veraruz, , Mexico
Lagos University Teaching Hospital
Lagos, , Nigeria
University Teaching Hospital of Kigali (CHUK)
Kigali, , Rwanda
Chris Hani Baragwanath Academic Hospital
Johannesburg, , South Africa
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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AL_20241016
Identifier Type: -
Identifier Source: org_study_id
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