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CTRI Number  CTRI/2025/02/079911 [Registered on: 03/02/2025] Trial Registered Prospectively
Last Modified On: 05/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   A prospective, online questionnaire 
Study Design  Other 
Public Title of Study   online survey on safety practices in operation theatre in a cancer hospital 
Scientific Title of Study   An online survey on safe operating room practices in tertiary care cancer hospitals in India 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
901101_Version 1.2 dated 02.12.2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Reshma Ambulkar 
Designation  Professor & Head 
Affiliation  Tata Memorial Centre 
Address  Department of Anesthesia Critical Care and Pain, Advanced Centre for Treatment, Research and Education in Cancer, Kharghar,Navi Mumbai

Raigarh
MAHARASHTRA
410210
India 
Phone  9821790448  
Fax    
Email  rambulkar@hotmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Reshma Ambulkar 
Designation  Professor & Head 
Affiliation  Tata Memorial Centre 
Address  Department of Anesthesia Critical Care and Pain, Advanced Centre for Treatment, Research and Education in Cancer, Kharghar,Navi Mumbai

Raigarh
MAHARASHTRA
410210
India 
Phone  9821790448  
Fax    
Email  rambulkar@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ashish Lokhande 
Designation  Junior Resident 2 
Affiliation  Tata Memorial Centre 
Address  Department of Anesthesia Critical care and Pain, Tata Memorial Hospital, Parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  7020729201  
Fax    
Email  lokhandeashish123@gmail.com  
 
Source of Monetary or Material Support  
Department of Anesthesia Critical Care and Pain, Advanced Centre for Treatment, Research and Education in Cancer, Kharghar, Navi Mumbai 
 
Primary Sponsor  
Name  Tata Memorial Centre 
Address  Department of Anesthesia Critical Care and Pain, Advanced Centre for Treatment, Research and Education in Cancer, Kharghar, Navi Mumbai 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Reshma Ambulkar  Advanced Centre for Treatment, Research and Education in Cancer  Department of Anesthesia Critical Care and Pain, Advanced Centre for Treatment, Research and Education in Cancer, Kharghar, Navi Mumbai
Raigarh
MAHARASHTRA 
9821790448

rambulkar@hotmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
HOMI BHABHA CANCER HOSPITAL AND RESEARCH CENTRE NEW CHANDIGARH IEC  Approved 
Homi Bhabha Cancer Hospital and Research Centre Vizag   Submittted/Under Review 
MAHAMANA PANDIT MADAN MOHAN MALAVIYA CANCER CENTRE AND HOMI BHABHA CANCER HOSPITAL  Approved 
Tata Memorial Centre Institutional Ethics Committee III  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Operation Room Personnel 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NA  Nil 
Comparator Agent  NA  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  All operation room personnel (ORP) concerned with patient care (Surgeons,
Anesthetists, Nursing staff and OR technicians) will be asked to participate  
 
ExclusionCriteria 
Details  Individuals not willing to participate in the study  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the patient safety culture of OR personnel who are concerned with patient care.  one time online responses obtained through questionnaires over 6 months duration 
 
Secondary Outcome  
Outcome  TimePoints 
Comprehensive analysis of operational, procedural, and cultural factors influencing safe operating room practices  One time survey 
 
Target Sample Size   Total Sample Size="1000"
Sample Size from India="1000" 
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)   20/02/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
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)   Not Applicable 
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  

The study title, “An online survey on safe operating room practices in tertiary care cancer hospitals in India”, is designed to assess the patient safety culture of Operating Room Personnel (Surgeons, Anesthetists, Nursing staff and OR technicians) who are concerned with patient care. Quality healthcare, especially patient safety, is crucial worldwide as this involved in prevention of medical errors that can lead to disastrous outcome. Errors in the operating room (OR) can include performing surgery on the wrong site, leaving instruments inside the body, medication error, delays in starting procedures, or infections from improper sterilization. These issues often arise due to poor communication, lack of resources, or failure to follow safety protocols. In India, where healthcare settings vary widely, these challenges can be even more pronounced, particularly in tertiary care cancer hospitals that handle complex cases. At Tata Memorial Centre, where complex surgeries are not so uncommon, operating room personnel face high-risk situations and are prone to errors. Assessing their safety attitudes is vital for improving patient safety. We will use the Safety Attitudes Questionnaire (SAQ) to measure the safety perceptions of Operating Room Personnel (ORP) across Tata Memorial Centre. This study aims to understand and improve the safety culture in operating rooms through a detailed survey.

 

 
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