CTRI

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CTRI Number

CTRI/2025/04/085185 [Registered on: 21/04/2025] Trial Registered Prospectively

Last Modified On:

11/03/2026

Post Graduate Thesis

Type of Trial

Observational

Type of Study

Cohort Study

Study Design

Other

Public Title of Study

Outcome Study In Acute Appendicitis Surgery To Improve Future Care

Scientific Title of Study

Appendicitis Global Outcomes Study: Identifying areas for whole systems strengthening in emergency care

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
Version 5.0 Dated 20th October 2024	Other

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Vishal Michael
Designation	Assistant Professor
Affiliation	Christian Medical College & Hospital Ludhiana
Address	Department of Pediatric surgery Ludhiana PUNJAB 141008 India
Phone	9780400296
Fax
Email	vishal.michael@cmcludhiana.in

Details of Contact Person
Scientific Query

Name	Dr Vishal Michael
Designation	Assistant Professor
Affiliation	Christian Medical College & Hospital Ludhiana
Address	Department of Pediatric surgery Ludhiana PUNJAB 141008 India
Phone	9780400296
Fax
Email	vishal.michael@cmcludhiana.in

Details of Contact Person
Public Query

Name	Dr Vishal Michael
Designation	Assistant Professor
Affiliation	Christian Medical College & Hospital Ludhiana
Address	Department of Pediatric surgery Ludhiana PUNJAB 141008 India
Phone	9780400296
Fax
Email	vishal.michael@cmcludhiana.in

Source of Monetary or Material Support

Non Funded Study. The study in India is coordinated by: Department of Pediatric Surgery and General Surgery alongwith the India HUb NIHR Health Research Unit on Global Surgery Christian Medical College Ludhiana, Punjab 141008 India

Primary Sponsor

Name	University of Birmingham
Address	Research Strategy Services Division Research Ethics Governance and Integrity University of Birmingham Birmingham B15 2TT researchgovernance@contacts.bham.ac.uk
Type of Sponsor	Research institution

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India
United Kingdom
Afghanistan
Albania
Algeria
Argentina
Australia
Austria
Azerbaijan
Bahrain
Belarus
Belgium
Benin
Bhutan
Bolivia
Bosnia and Herzegovina
Botswana
Brazil
Bulgaria
Burkina Faso
Burundi
Cambodia
Cameroon
Canada
Chad
Chile
China
Colombia
Congo
Croatia
Cuba
Cyprus
Czech Republic
Dominican Republic
Ecuador
Egypt
Estonia
Ethiopia
Fiji
France
Gambia
Georgia
Germany
Ghana
Greece
Guatemala
Honduras
Hungary
Iceland
Indonesia
Iran (Islamic Republic of)
Iraq
Ireland
Israel
Italy
Jamaica
Japan
Jordan
Kazakhstan
Kenya
Kuwait
Kyrgyzstan
Latvia
Lebanon
Liberia
Libyan Arab Jamahiriya
Lithuania
Luxembourg
Macedonia
Madagascar
Malaysia
Malta
Mexico
Mongolia
Morocco
Mozambique
Namibia
Nepal
Netherlands
New Zealand
Niger
Nigeria
Norway
Oman
Pakistan
Panama
Papua New Guinea
Paraguay
Peru
Philippines
Poland
Portugal
Qatar
Republic of Korea
Romania
Russian Federation
Rwanda
Saudi Arabia
Serbia
Sierra Leone
Slovenia
Somalia
South Africa
Spain
Sri Lanka
Sudan
Swaziland
Sweden
Switzerland
Syrian Arab Republic
Tanzania
Thailand
Tunisia
Turkey
Uganda
Ukraine
United Arab Emirates
United States of America
Uruguay
Venezuela (Bolivarian Republic of)
Viet Nam
Yemen
Zambia
Gabon
Senegal
Singapore
Other

Sites of Study

No of Sites = 37
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Manoj Kumar	Rani Durgavati Medical College	Department of General Surgery, Ground Floor OPD Banda UTTAR PRADESH	7704094496 drmanojmahor2016@gmail.com
DrShrirang Kulkarni	7 Air Force Hospital	Department of Gastrointestinal Surgery Kanpur Nagar UTTAR PRADESH	9958645020 drsvkq@yahoo.com
Dr Chandraskehar Mahakalkar	Acharya Vinoba Bhave Rural Hospital Wardha	Department of General Surgery Wardha MAHARASHTRA	9822369277 cmahakalkar@rediffmail.com
Dr Aditya Baksi	All India Institute of Medical Sciences	Department of Surgical Disciplines, Room Number 426, Surgery Block New Delhi DELHI	9830812905 aditya.baksi@gmail.com
Dr Hari Kesh Yadav	All India Institute of Medical Sciences	Department of General Surgery FIRST FLOOR, OPD ROOM NO. 106 Gorakhpur UTTAR PRADESH	917520655329 hk.mssurgery@gmail.com
Dr Pradeep Saxena	All India Institute of Medical Sciences	Department of Surgery Bhopal MADHYA PRADESH	9826295219 pradeep.surgery@aiimsbhopal.edu.in
Dr Satya Prakash Meena	All India Institute of Medical Sciences	Department of General Surgery Jodhpur RAJASTHAN	8010861072 drsatyaprakash04@gmail.com
DrTridip Dutta Baruah	All India Institute of Medical Sciences	Department of General Surgery Raipur CHHATTISGARH	9109720246 tridipduttabaruah@gmail.com
DrTushar S Mishra	All India Institute Of Medical Sciences Bhubaneswar	Department of Surgery, Ground Floor Room number 64 Khordha ORISSA	9438884251 surg_tushar@aiimsbhubaneswar.edu.in
Dr Krishna Ramavath	All India Institute of Medical Sciences, Bibinagar	Department of General Surgery Ground floor, room no 39 Hyderabad TELANGANA	7780438921 krishnaramavath149@gmail.com
DrDhiraj Mallik	All India Institute of Medical Sciences, Kalyani	Department of General Surgery, OPD building 2nd floor, Room 202 Nadia WEST BENGAL	9874806628 dhiraj.gensurg@aiimskalyani.edu.in
Dr Sandeep Singh Sen	All Indian Institute of Medical Sciences	Department of Pediatric Surgery, Room no 323, Ground floor B block Bilaspur HIMACHAL PRADESH	8968293459 sandeepsen154@gmail.com
ColVipin V Nair	Armed Force Medical College	Department of Surgery Pune MAHARASHTRA	9599757675 vipinvenugopalnair@gmail.com
DrAnkur Garg	Atal Bihari Vajpayee Institute Of Medical Sciences And Dr RML Hospital	Department of General Surgery, Ward 16 Room No 201 Central DELHI	9873741430 drankurgarg88@gmail.com
Dr Satish Dharap	B.Y.L Nair Hospital & T.N Medical College	Department of General Surgery Mumbai MAHARASHTRA	9869042629 drdharap@gmail.com
Dr Sunil Kumar Venkatappa	Banglore Medical College & Research Institute	Department of General Surgery Bangalore KARNATAKA	7702692660 sunildocv@gmail.com
Dr Nischal K	BGS Global Institute of Medical Sciences	Department of General Surgery Bangalore KARNATAKA	9900151574 knischal697@gmail.com
DrMoa Meren	Christian Institute of Health Sciences and Research	Department of Surgery Dimapur NAGALAND	60094 64269 merenmoa53@gmail.com
Dr Vishal Michael	Christian Medical College & Hospital	Department of Paediatric Surgery, Ground Floor Ludhiana PUNJAB	9780400296 vishal.michael@cmcludhiana.in
DrIP Yadev	Government Medical College	Department of General Surgery Kollam KERALA	8089432278 yadev@compassionatecare.in
DrAshwani Kumar	Government Medical College	Department of General Surgery and Laparoscopic surgery,Ward 2, Ground floor Patiala PUNJAB	9815504819 ashwanicmc@gmail.com
DrSimrandeep singh	Government Medical College Hospital	Department of Surgery, Room Number D347 Level III Block C Chandigarh CHANDIGARH	9646121501 simrandeep696@gmail.com
DrSathish Muthu	Government Medical College Hospital Karur	Department of General Surgery Kapur TAMIL NADU	9600856806 drsathishmuthu@gmail.com
Dr Thirunavukkarasu Sellamuthu	Government Medical College Omandurar Government Estate	Department of General Surgery,7th floor Chennai TAMIL NADU	9962558343 thirukmc@yahoo.co.in
Dr Ashish Chhabra	Guru Gobind Singh Medical College & Hospital	Department of Pediatric Surgery Faridkot PUNJAB	9779246506 drashishchhabra@yahoo.com
Dr Supreet Kaur	Guru Teg Bahadur Hospital	Department of General Surgery ward 24 New Delhi DELHI	8146933887 supgrewal@gmail.com
DrReddy Abhinaya	Jawaharlal Institute of Postgraduate Medical Education and Research	Department of General Surgery, Second floor,Old hospital building Pondicherry PONDICHERRY	8195014433 Reddy.kmc2k6@gmail.com
DrAlfie Kavalakat	Jubilee Mission Medical College & Research Institute	Department of General Surgery Thrissur KERALA	9447496650 alfiejose@gmail.com
DrPrasad S S	Kasturba Medical College Hospital Manipal	Department of General Surgery, 3rd Floor, Smt. Sharada Madhav Pai OPD building Udupi KARNATAKA	7838177803 drprasadss@gmail.com
DrAbhinav Arun Sonkar	King George Medical University	Department of General Surgery Lucknow UTTAR PRADESH	9839017609 abhinavarunsonkar@gmail.com
DrPhilip Alexander	Lady Willingdon Hospital Manali	Department of Surgery Kullu HIMACHAL PRADESH	9816033110 philalex1@gmail.com
DrRajeev Redkar	Lilavati Hospital & Research Centre, Mumbai	Department of Paediatric surgery Bhandara MAHARASHTRA	9820041156 rajeev.redkar@gmail.com
DrKaraninder Singh Wilku	Maharishi Markandeshwar Medical College And Hospital	Department of Surgery, 6th floor Surgery ward Solan HIMACHAL PRADESH	8607690190 dr.karaninder@gmail.com
Dr Lovenish Bains	Maulana Azad Medical College	Department of General Surgery, Room no 201, BL Taneja Block New Delhi DELHI	9968604377 lovenishbains@gmail.com
Dr Fazlul Qadir Parray	Sher-I- Kashmir Institute of Medical Sciences	Department of General surgery, Ist floor Main Building, Room No. 2301 Srinagar JAMMU & KASHMIR	9419008550 fazlparray@rediffmail.com
DrNissar Hamdani	SMHS Hospital, Government Medical College	Department of Surgical Gastroenterology, 3rd Floor, Room No.11 Srinagar JAMMU & KASHMIR	9086888948 drnisarhamdani@gmail.com
Dr Rahul Gupta	Synergy Institute of Medical Sciences, Dehradun	Department of Gastrointestinal Surgery Dehradun UTTARANCHAL	9501914432 rahul.g.85@gmail.com

Details of Ethics Committee
Modification(s)

No of Ethics Committees= 39
Name of Committee	Approval Status
7 AIR FORCE HOSPITAL	Approved
ARMED FORCES MEDICAL COLLEGE	Approved
BGS MCH INSTITUTIONAL ETHICS COMMITTEE BANGALORE	Approved
ETHICS COMMITTEE ABVIMS AND DR. RAM MANOHAR LOHIA HOSPITAL NEW DELHI	Approved
ETHICS COMMITTEE FOR BIOMEDICAL AND HEALTH RESEARCH Lilavati Hospital & Research Centre, Mumbai	Approved
ETHICS COMMITTEE OF BMCRI	Approved
Guru Teg Bahadur Hospital Delhi	Approved
INSTITUTE EHTICS COMMITTEE FOR BIOMEDICAL AND HEALTH RESEARCH AIIMS Delhi	Approved
Institutional Ethics Committee Maharishi Markandeshwar Medical College And Hospital Solan	Approved
Institutional Ethics Committee	Approved
Institutional Ethics Committee and Biomedical Health Research Gautuam Bhudha Chikitsa Mahavidyalaysa	Approved
Institutional Ethics Committee Acharya Vinoba Bhave Rural Hospital	Approved
INSTITUTIONAL ETHICS COMMITTEE AIIMS BHUBANESWAR	Approved
Institutional Ethics Committee AIIMS Bibinagar	Approved
Institutional Ethics Committee AIIMS Gorakhpur	Approved
Institutional Ethics Committee AIIMS Kalyani	Approved
Institutional Ethics Committee AIIMS Patna	Approved
Institutional Ethics Committee AIIMS Patna	Approved
Institutional Ethics Committee AIIMS Rishikesh	Approved
Institutional Ethics Committee CMC Ludhiana	Approved
INSTITUTIONAL ETHICS COMMITTEE GMC Chandigarh	Approved
Institutional Ethics Committee GMC Patiala	Approved
Institutional Ethics Committee Government Medical College Omandurar Government Estate Chennai	Approved
INSTITUTIONAL ETHICS COMMITTEE HUMAN STUDIES Rani Durgavati Medical College, Banda	Approved
Institutional Ethics Committee JIPMER	Approved
INSTITUTIONAL ETHICS COMMITTEE JUBLIEE MISSION HOSPITAL THRISSUR	Approved
Institutional Ethics Committee KB Bhabha Hospital	Approved
Institutional Ethics Committee MAMC	Approved
Institutional Ethics Committee Military Hospital Khadki	Approved
Institutional Ethics Committee Nil Ratan Sircar Medical College	Approved
Institutional Ethics Committee SKIMS Srinagar	Approved
Institutional Ethics Committee SPS Hospital	Approved
Institutional Ethics Committee St Stephen Hospital	Approved
INSTITUTIONAL ETHICS COMMITTEE, GURU GOBIND SINGH MEDICAL COLLEGE	Approved
INSTITUTIONAL ETHICS COMMITTEE-BIOMEDICAL AND HEALTH RESEARCH AIIMS Bilaspur	Approved
Institutional Human Ethics Committee GMC Karur	Approved
INSTITUTIONAL HUMAN ETHICS COMMITTEE OF AIIMS BHOPAL	Approved
INSTITUTIONALETHICSCOMMITTEE JIPMER	Approved
KASTURBA MEDICAL COLLEGE AND KASTURBA HOSPITAL INSTITUTIONAL ETHICS COMMITTEE	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: K35\|\|Acute appendicitis,

Intervention / Comparator Agent

Type	Name	Details
Intervention	NIL	NIL
Comparator Agent	NIL	NIL

Inclusion Criteria

Age From	1.00 Month(s)
Age To	99.00 Year(s)
Gender	Both
Details	- 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. - All patients undergoing appendicectomy for suspected or confirmed appendicitis by any surgical approach should be included. This includes pa5ents 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. - Both open and minimally invasive (laparoscopic and robotic) interven5ons are eligible for inclusion. Laparoscopic and robotic converted to open cases are also eligible.

ExclusionCriteria

Details

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

- 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.

- Natural orifice surgery and endoscopic treatment for suspected appendicitis are excluded.

-Patients having surgery for stump appendicitis are excluded.

- Patients should be entered into study only once. A patient returning to theatre after appendectomy
should not be re-entered as a new patients.

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome

TimePoints

- Time from symptom onset to
first assessment by the
surgical team.

- Proportion of all patients with histology-confirmed appendicitis who had a perforated appendix on histology
- Proportion of all patients having preoperative cross-sectional (CT/MRI) imaging

- Proportion of all patients undergoing a laparoscopic approach for appendicectomy

- Duration from decision to operate to knife to
skin
- Proportion of all patients with a histologically normal appendix
- Post-operative length of stay
- 30-day overall Clavien-Dindo
complications

30 day follow up

Secondary Outcome

Outcome	TimePoints
NIL	NIL

Target Sample Size

Total Sample Size="14000"
Sample Size from India="3000"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Phase of Trial

N/A

Date of First Enrollment (India)

25/04/2025

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

03/02/2025

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="1"
Months="0"
Days="0"

Recruitment Status of Trial (Global)
Modification(s)

Open to Recruitment

Recruitment Status of Trial (India)

Open to Recruitment

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

Background

Acute appendicitis is one of the most common surgical emergencies worldwide. Presentation of appendicitis and its management can serve as a benchmark to evaluate the efficiency and effectiveness of emergency health systems. The aim of this prospective cohort study is to identify areas for whole systems strengthening in emergency care using pre-defined key performance measures.

Methodology

This international prospective, multicentre, cohort study will include consecutive patients undergoing appendicectomy for suspected appendicitis. A measurement set comprising key outcome measures has been pre-defined to comprehensively evaluate emergency system performance across the world. Hospital teams of up to 3 collaborators will collect data on consecutive patients of any age undergoing appendicectomy in pre-defined 14-day blocks. Patients will be followed up at 30-days to collect outcome data.

Multiple teams may participate in data collection in the same hospital but in different 14-day blocks. There will be no changes made to routine patient care pathways/management or follow-up in this observational study.

Two hospital level surveys will be included in the study. One is a mandatory site survey for all hospitals participating and the second will be an optional World Health Organisation hospital emergency assessment tool survey. There will be two nested sub-studies on sustainability and waste management, and financing. Consultant Leads in each participating hospital must ensure appropriate study registration approval as per local regulations and this is mandatory for participation.

Discussion

This study will generate granular data on the global variability in appendicectomy management and outcomes, offering insights into access to emergency care, imaging, and minimally invasive surgery. The findings will guide recommendations for both high-income and low- and middle-income countries, informing government policy and improving patient outcomes.