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CTRI Number  CTRI/2024/02/062764 [Registered on: 16/02/2024] Trial Registered Prospectively
Last Modified On: 29/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective Observational Study 
Study Design  Other 
Public Title of Study   A study to identify the reasons for cancellation of short procedures under anaesthesia in a cancer hospital. 
Scientific Title of Study   A single-centre prospective observational study to analyse the cancellation of day care procedures planned under anaesthesia in a tertiary care oncology hospital. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
4313_Protocol_Version 1.1 dated 12.12.23  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Bindiya Salunke 
Designation  Associate Professor 
Affiliation  Tata Memorial Hospital 
Address  Dept. of Anaesthesia, Critical Care and Pain, Second Floor, Main Building, Tata Memorial Hospital Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9764924231  
Fax    
Email  bindi02@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Bindiya Salunke 
Designation  Associate Professor 
Affiliation  Tata Memorial Hospital 
Address  Dept. of Anaesthesia, Critical Care and Pain, Second Floor, Main Building, Tata Memorial Hospital Parel, Mumbai


MAHARASHTRA
400012
India 
Phone  9764924231  
Fax    
Email  bindi02@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Devika R 
Designation  Junior Resident 
Affiliation  Tata Memorial Hospital 
Address  Dept. of Anaesthesia, Critical Care and Pain, Second Floor, Main Building, Tata Memorial Hospital Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  8547478176  
Fax    
Email  devikareghu@yahoo.com  
 
Source of Monetary or Material Support  
Dept. of Anaesthesia, Critical Care and Pain, 2nd Floor Main Building, Tata Memorial Hospital, Dr Ernest Borges Road, Parel, Mumbai, Maharashtra 400012 
 
Primary Sponsor  
Name  Tata Memorial Hospital  
Address  Dr. E Borges Road Parel, Mumbai Pin 400012 
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 Bindiya Salunke  Tata Memorial Hospital  Dept. of Anaesthesia, Critical Care and Pain, Second Floor, Main Building, Tata Memorial Hospital Parel, Mumbai
Mumbai
MAHARASHTRA 
9764924231

bindi02@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
TMH_Institutional Ethics Committee II  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  NA 
Comparator Agent  Nil  NA 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  90.00 Year(s)
Gender  Both 
Details  All the scheduled day care procedures under anaesthesia posted in minor operation theatre which were cancelled  
 
ExclusionCriteria 
Details  1. Emergency cases
2. IPD patients posted in minor OT
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To calculate the incidence of cancellation of day care procedures needing anaesthesia.  Prior to start of procedure 
 
Secondary Outcome  
Outcome  TimePoints 
1.Root cause analysis of the individual cancellation.
2.Classification of causes of cancellations into avoidable and unavoidable
 
At the end of the day of scheduled procedure 
 
Target Sample Size   Total Sample Size="500"
Sample Size from India="500" 
Final Enrollment numbers achieved (Total)= "49"
Final Enrollment numbers achieved (India)="49" 
Phase of Trial   N/A 
Date of First Enrollment (India)   26/02/2024 
Date of Study Completion (India) 25/09/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 25/09/2024 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  

II

Introduction:

Rate of cancellation of elective surgeries on day of surgery is reported world-wide ranging from 1.96-24%1-2. Cancellation of scheduled elective cases on day of surgery has multiple implications and it implies poor quality of patient care and hospital management. Cancellation on day of surgery leads to both institutional loss by causing waste of operating room time, hospital resources as well as inconvenience to patients and their kin both psychologically and financially due to increased hospital stay, fasting requirements, loss of day wages and the possible need to repeat certain investigations3-8.

Cancellation of day care procedures posted under anaesthesia also cause similar issues. Many a times day care procedures especially in cancer institute are for diagnostic purpose and delaying these procedures leads to delay in further planning and initiation of cancer therapy. We decided to conduct this audit to find out the current rate of cancellations in our institute, to analyse the causes, classify them into potentially avoidable and unavoidable causes, and furthermore, to suggest the solutions to minimise avoidable causes.

Aim:

Analysis of cancellations in day care procedures

 

Objectives:

Primary: To calculate the incidence of cancellation of day care procedures needing anaesthesia.

 

Secondary:

1) Root cause analysis of the individual cancellation.

2) Classification of causes of cancellations into avoidable and unavoidable

Methodology:

 

Design: A prospective observational study.

 

Sample size: Patients recruited over a period of four months or 500 patients, whichever is earlier. 

After IEC approval and CTRI registration, the recruitment will proceed, to include all those patients who had cancellations on the day of surgery, when planned day care procedures under anaesthesia.

 

 Sites: This is a single-centre study.

We will get the record of all the cases posted for day care procedures from the registration counter of minor OT. If any case which was initially posted under anaesthesia but the procedure gets cancelled for that day then that case will be included in the study.

The reason for cancellations along with the demographics of the patient will be recorded. We will also screen for documentation of pre-procedure instructions on the electronic medical record (EMR), and patients’ file. The details from the pre anaesthesia check up if any will also be recorded.

Reason for cancellation with their opinion will be noted in the CRF by OT anaesthetist and surgeons separately. And also we will record suggestions to avoid such postponement in future by both OT anaesthetist and surgeron. Their opinion and suggestion will be completely voluntary and their willingness to give their suggestions will be considered as their consent.

At the end we will analyse all the details of the causes of cancellation of day care procedure and try to find out the corrective measures for the avoidable causes.

Statistical Analysis Plan: Descriptive data will be analyzed using frequencies and percentages for categorical variable and mean and standard deviation/ median (IQR) from continuous variables.

 
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