ALLIGATOR Study

1. Background
Registration Number	INA-65DKMRRN
Date of registry approval	30-12-2024
Registration Date	13-12-2024
Secondary identifiers	Yes
Name of issuing authority (for example protocol number, other registries, etc)	University of Birmingham
Secondary identifier number	ERN_3201-Oct2024
Scientific study title	Appendicitis Global Outcomes Study (Indonesia)
Public (popular study title)	ALLIGATOR Study
2. Sponsor and Funding
Primary Sponsor	Department of Anesthesiology Faculty of Medicine Udayana University
Source(s) of monetary or material support	Internal funding
Other partners
3. Contact details
Principal Investigator
Principal investigator	Christopher Ryalino
City	Denpasar
Country	Indonesia
Principal investigator's affiliation	Department of Anesthesiology Faculty of Medicine Udayana University
Principal Investigator's email address	ryalino@unud.ac.id
Public Queries
Contact person name for public queries	Christopher Ryalino
Address for public queries	Department of Anesthesiology Faculty of Medicine Udayana University Jl. PB Sudirman
City	Denpasar
Country	Indonesia
ZIP	80232
Affiliation for public queries	Department of Anesthesiology Faculty of Medicine Udayana University
Email address for public queries	ryalino@unud.ac.id
Phone number for public queries	082144224466
Scientific Queries
Name of Contact for scientific queries	Steven Okta Chandra
Address for scientific queries	Department of Anesthesiology Faculty of Medicine Udayana University Jl. PB Sudirman
City	Denpasar
Country	Indonesia
ZIP	80232
Affiliation of scientific queries contact	Department of Anesthesiology Faculty of Medicine Udayana University
Email address for scientific queries	stevenokta@student.unud.ac.id
4. IRB & Regulatory
Ethical Approval number	ERN_3201-Oct2024
Name of Ethics committee	Science, Technology, Engineering and Mathematics Committee, University of Birmingham, UK
Date of Ethic approval	01-10-2024
Contact details of Ethic Committee (phone, email, and office)	Phone: +44 121 414 3344 ethics-queries@contacts.bham.ac.uk
Number of Persetujuan Pelaksanaan Uji Klinik (PPUK)/Persetujuan Protokol Uji BE (PPUB)	Not applicable
5. Status
Countries of recruitment	This is an international multicentered study of >66 countries, including the UK and Indonesia. https://www.globalsurgeryunit.org/clinical-trials-holding-page/project-alligator/
Study sites in Indonesia	University of Udayana (Denpasar) University of Indonesia (Jakarta) University of Airlangga (Surabaya) University of Padjajaran (Bandung) University of Diponegoro (Semarang) University of Hasanuddin (Makassar) University of North Sumatera (Medan) University of 11 Maret (Surakarta) University of Sriwijaya (Palembang) University of Brawijaya (Malang) University of Syiah Kuala (Banda Aceh) University of Lambung Mangkurat (Banjarmasin) University of Soedirman (Puwrokerto) University of Riau (Riau) University of Sam Ratulangi (Manado)
Recruitment status	Initial
Date of first enrollment	03-02-2025
Targeted Sample size	00200 -
Number of enrolled participants	0
Date of study completion (last participant, last visit)
6. Study Design & Purpose
Primary health condition(s) or problem(s) studied (e.g., depression, breast cancer,medication error)	Appendicitis
Purpose of the study	Health services research
Study type	Observational
Method of allocation
Description of the allocation concealment mechanism and sequence generation
Masking
Study intervention (study arm)
Control intervention (control arm)
Intervention assignment
7. Eligibility Criteria
Gender inclusion criteria	Male, Female
Minimum age	0
Maximum age	99
Inclusion criteria	All patients of all ages and sexes undergoing appendicectomy for suspected or confirmed appendicitis by any surgical approach.
Exclusion criteria	Appendicectomy for any indication other than suspected or confirmed appendicitis, patients having appendectomy as part of another surgical procedure, having surgery for stump appendicitis, and patients returning to the theatre after appendectomy.
8. Study Outcome
Primary Outcome
Name of primary outcome	30-day overall Clavien-Dindo complications
Metric/method of measurement	8-point scale of Clavien-Dindo classification. Tool: https://www.assessurgery.com/clavien-dindo-classification/
Timepoint(s) of measurement	30 days after surgery. Day of surgery is considered day 0.
Secondary outcome 1
Name of secondary outcome 1 (SO1)	Time from first assessment to theatre.
Metric/method of measurement (SO1)	The time required between the time of first assessment and the time of incision. This will be measured in minutes.
Timepoint(s) of measurement (SO1)	Upon incision.
Secondary outcome 2
Name of secondary outcome 2 (SO2)	Negative appendicectomy rate
Metric/method of measurement (SO2)	Proportion of all patients with a histologically normal appendix.
Timepoint(s) of measurement (SO2)	Upon the availability of histologic examination.
Secondary outcome 3
Name of secondary outcome 3 (SO3)	Post-operative length of stay
Metric/method of measurement (SO3)	Length of stay (in days) in hospital after appendicectomy. Day of surgery is considered day 0.
Timepoint(s) of measurement (SO3)	Upon hospital discharge.
Secondary outcome 4
Name of secondary outcome 4 (SO4)	Time from symptom onset to first assessment by the surgical team
Metric/method of measurement (SO4)	Duration from onset of symptoms to first assessment by the surgical team. Measured in minutes.
Timepoint(s) of measurement (SO4)	Upon assessment.
Secondary outcome 5
Name of secondary outcome 5 (SO5)	Perforation rate
Metric/method of measurement (SO5)	Proportion of all patients with histologyconfirmed appendicitis who had a perforated appendix on histology
Timepoint(s) of measurement (SO5)	Upon the availability of histologic examination.
9. Study Results
Brief summary of study results	Unavailable. The study has not yet been conducted.
Date of results summaries	13-12-2024
Participant flow
Baseline characteristic
Adverse events
Outcome measures
10. Publication
URL hyperlink(s) related to results and publications
IPD sharing statement (Statement regarding the intended sharing of deidentified individual clinical trial participant-level data (IPD))	Undecided
Plan for IPD sharing (what IPD will be shared, when, by what mechanism, with whom, and for what types of analyses)
Other important informations	This is an international, multicentered study of 168 countries. The main objective of the ALLIGATOR study is to identify areas for strengthening the emergency surgery system using appendicitis as a tracer condition with a predefined set of key performance measures. For further information: https://www.globalsurgeryunit.org/clinical-trials-holding-page/project-alligator/