| 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
|
|
|
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
|
|
|
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. |