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O estudo clínico NCT06774001 (AlliGatOr) para Apendicite, Apendicectomia está recrutando. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui. | ||
Universidade de BirminghamA Global Prospective Cohort Study on Outcomes of Appendicectomy for Appendicitis (AlliGatOr)
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.
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.
A Global Prospective Cohort Study on Outcomes of Appendicectomy for Appendicitis
- AlliGatOr
- AL_20241016
Appendicitis
Appendectomy
| Grupo de participantes/Braço | Intervenção/Tratamento |
|---|---|
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. |
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
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 |
- 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.
- 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.
Universidade de Birmingham579 estudos clínicos ativos para explorar- ⚕️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