FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/10/046350 [Registered on: 11/10/2022] 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 find the reasons for cancellation of scheduled surgeries done in the hospital 
Scientific Title of Study   Cancellation of Elective Surgery On A Scheduled Day In A Tertiary Cancer Hospital – A Quality Improvement Audit. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
4022_Protocol version 2, dated 24.08.2022  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nayana Amin 
Designation  Professor Anaesthesia 
Affiliation  Tata Memorial Centre 
Address  Department of Anaesthesia, Critical care and Pain, 2nd Floor, Main Building, Tata Memorial Hospital, Dr. E.B Road, Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9820742327  
Fax    
Email  drnayana.amin@yahoo.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nayana Amin 
Designation  Professor Anaesthesia 
Affiliation  Tata Memorial Centre 
Address  Department of Anaesthesia, Critical care and Pain, 2nd Floor, Main Building, Tata Memorial Hospital, Dr. E.B Road, Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9820742327  
Fax    
Email  drnayana.amin@yahoo.in  
 
Details of Contact Person
Public Query
 
Name  Aditi Newaskar 
Designation  Junior resident 
Affiliation  Tata Memorial Centre 
Address  Department of Anaesthesia, Critical care and Pain, 2nd Floor, Main Building, Tata Memorial Hospital, Dr. E.B Road, Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9765149938  
Fax    
Email  newaditi01@gmail.com  
 
Source of Monetary or Material Support  
Tata Memorial Hospital 
 
Primary Sponsor  
Name  Tata Memorial Centre 
Address  Department of Anaesthesia, Critical care and Pain, 2nd Floor, Main Building, Tata Memorial Hospital, Dr. E.B Road, Parel, 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 Nayana Amin  Tata Memorial Centre  Department of Anaesthesia, Critical care and Pain, 2nd Floor, Main Building, Tata Memorial Hospital, Dr. E. B Road, Parel, Mumbai
Mumbai
MAHARASHTRA 
9820742327

drnayana.amin@yahoo.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Commitee-I  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 
Comparator Agent  Nil  NA 
Intervention  Nil  Not applicable 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  85.00 Year(s)
Gender  Both 
Details  All adult and pediatric patients scheduled for elective surgery in major OT complex including operation theatres in TMC will be enrolled in study. 
 
ExclusionCriteria 
Details  Patients posted for minor OT procedures in TMC, emergency procedures and day care procedures and procedures in radiology suite. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To see the incidence and reasons for cancellation within 24 h of scheduled surgery in a tertiary cancer centre  within 24 h of scheduled surgery  
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Not Applicable 
 
Target Sample Size   Total Sample Size="10000"
Sample Size from India="10000" 
Final Enrollment numbers achieved (Total)= "10000"
Final Enrollment numbers achieved (India)="10000" 
Phase of Trial   N/A 
Date of First Enrollment (India)   14/10/2022 
Date of Study Completion (India) 31/12/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 31/12/2022 
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   Not Applicable 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

INTRODUCTION

One of the key performance indicator of any healthcare facility is optimal utilization of resources which not only reduces operational costs but also improves patient satisfaction. Operation theatres and intensive care units are the largest revenue generators for the hospital. There are various factors which can prevent optimal utilization of operating room resources and cancellation of scheduled surgeries is one of them. Cancellation of elective surgery especially within 24 hrs of scheduling not only results in wastage of resources, but also has a significant psychosocial impact on the patients.

Cancer surgeries are considered as semi-emergencies. Any delay in scheduling or cancellation of scheduled cases can cause significant distress to the patients and their family. We already have very long waiting lists and any delay in rescheduling cancelled cases can lead to disease progression.Cancellation of surgery leads unnecessary expenditure and wastage of hospital resources.it also increases the psychological trauma and financial burden on the patient and their family.

Studies have shown that cancellation rates vary between different hospitals and ranges from 5-40% depending on the type of hospital (private/teaching institute/ charitable institutes) and size of the hospital (number of hospital beds). We would like to do this quality improvement audit to see the cancellation rates in our institute which is an academic institute and a tertiary cancer referral centre.

PRIMARY OBJECTIVE: To see the incidence and reasons for cancellation within 24 h of scheduled surgery in a tertiary cancer centre.

SECONDARY OBJECTIVE: Identifying areas for intervention to reduce avoidable surgery cancellations and reduce waste of resources.

INCLUSION CRITERIA: All adult and pediatric patients scheduled for elective surgery in major OT complex including operation theatres in TMC will be enrolled in study.

EXCLUSION CRITERIA: Patients posted for minor OT procedures in TMC, emergency procedures and day care procedures and procedures in radiology suite.

STUDY METHODOLOGY: This is a prospective observational study to see the incidence and reasons for cancellation of scheduled elective surgical procedures in major operation theatres in Tata Memorial Centre. This study is a part of MD dissertation at Tata Memorial Centre and will be conducted after approval from institutional ethics committee and CTRI registration.

The study group will include all patients scheduled for elective surgical procedures and patients who are kept as standby for scheduled cases. A list of scheduled cases is made a day prior to surgery. This list is shared with all the OT staff (Surgeons, Anaesthetists and nursing staff). Patients who are scheduled for surgery are admitted a day prior to the scheduled date of surgery. There would be a few cases kept as standby in case an OT slot is available. A list of standby cases will be obtained from the surgical registrar of the units which are operating on the scheduled date. At the end of the day, Co-investigator and research nurse will interview the OT anaesthetist and primary surgeons to find out if any of scheduled case has been cancelled. The reasons for cancellation will be obtained from the surgical registrar, respective OT anaesthetist, OT staff or from electronic medical records.All this information will be obtained within 24 hrs of scheduling and cancellation.

The following data will be recorded.

•        Demographic data: Age, gender, height, weight.

•        Surgical unit

•        Diagnosis

•        Date of hospital admission and discharge

•        Plan of surgery

•        ASA status

•        Details of comorbidities

•        Pre operative medication details

•        Details of preoperative chemotherapy

•        Preoperative investigation details

•        Whether PAC was done or not?

•        Was review PAC asked for?

•        Any advice given in PAC?

•        Was final fitness given in PAC?

•        Vital parameters recorded in PAC (Heart rate, blood pressure, saturation in PAC)

•        Was case informed to OT anaesthtist a day prior to surgery

•        IF Patient was seen on EMR the previous day, any advice was given, if any reason it could not be followed.

•        If patient was seen clinically the previous day, any advice was given, if any reason it could not be followed

•        Scheduled or standby case

•        Timing of cancellation- day prior to surgery, before taking to OT, on table before induction of anaesthesia or after induction of anaesthesia.

•        Reason for cancellation of surgery (cancelled by surgeon, anathesiologist, patient refusal)

This is a quality improvement audit. All patients will receive treatment according to current standards of care. No additional interventions or change in management will be done for the purpose of the study. Data will be collected from the electronic medical records, surgeons and anaethetist who are involved in the care of the patient. At no point in the study will there be any patient contact. No biological samples will be taken from the patient. There are no stop points or withdrawal criteria.

STATISTICAL ANALYSIS:

Descriptive analysis will be used to summarize patient characteristics at baseline. Continuous variables will be presented as the mean ± standard deviation (SD) or Median (IQR) based on normality of the data. Categorical data will be presented as numbers (percentages). Normality of data will be assessed using Shapiro Wilk test.

For objectives, Univariate and multivariable logistic regression will be conducted for comparisons between surgery cancellation and predictors of interest (patient, surgeon and system factors) in tertiary academic hospital.

A stepwise backward LR selection method will be used for the multivariable logistic regression model. P value < 0.05 will be considered statistically significant.

Software: All analysis will be two sided, and significance will set at a p-value of 0.05. Statistical analyses will be performed using R v3.4.3 software and SPSS (the statistical package for social sciences) IBM Corp. Released 2017.IBM SPSS Statistics for Windows, Version 25.0. Armonk, NY: IBM Corp.

 
Close