A Global Prospective Cohort Study on Outcomes of Appendicectomy for Appendicitis

NCT06774001 | Recruiting

• 1 other identifier: AL_20241016
• Study Type: observational
• Target: 14,000
• Locations: 7 countries
• Sites: 7

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.

Conditions

Appendicitis; Appendectomy

Keywords

Appendicectomy; Appendicitis; Appendectomy

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (1)

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

Interventions

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.

Appendicectomy for suspected or confirmed appendicitis

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Indication: Appendicectomy for any indication other than suspected or confirmed appendicitis should be excluded. For example, patients having appendicectomy for known appendiceal neoplasm.
• 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.

Sponsors & Collaborators

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

Study Sites (7)

University of Abomey Calavi

Cotonou, Benin

NOT YET RECRUITING

Tamale Teaching Hospital

Tamale, Ghana

RECRUITING

Christian Medical College and Hospital Ludhiana

Ludhiana, India

NOT YET RECRUITING

Hospital Espanol Veracruz

Veraruz, Mexico

RECRUITING

Lagos University Teaching Hospital

Lagos, Nigeria

RECRUITING

University Teaching Hospital of Kigali (CHUK)

Kigali, Rwanda

NOT YET RECRUITING

Chris Hani Baragwanath Academic Hospital

Johannesburg, South Africa

RECRUITING

MeSH Terms

Conditions

Appendicitis

Interventions

Appendectomy

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Aneel Bhangu

  University of Birmingham

  STUDY DIRECTOR

Central Study Contacts

Teddy Anyomih

CONTACT

+441214143344; t.t.k.anyomih@bham.ac.uk

Rachel Lillywhite

CONTACT

r.e.lillywhite@bham.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2025
• First Posted: January 14, 2025
• Study Start: February 3, 2025
• Primary Completion: May 25, 2025
• Study Completion: December 1, 2025
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1); IN (1); GH (1); NG (1); BE (1); RW (1); ZA (1)