| CTRI Number |
CTRI/2026/03/105093 [Registered on: 02/03/2026] Trial Registered Prospectively |
| Last Modified On: |
27/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To understand why some patients need to get repeated visits to anaesthesia fitness opd before they are given clearance for surgery. |
|
Scientific Title of Study
|
A prospective observational review of existing pre-operative factors affecting pre-anaesthesia check reassessment and evaluation in oncology patients and development of a Pre-anaesthesia check complexity score |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gauri Raman Gangakhedkar |
| Designation |
Associate Professor |
| Affiliation |
ACTREC ,TMC,Navi mumbai |
| Address |
Department of Anaesthesiology ,Critical care and Pain , Tata Memorial Centre ,ACTREC ,Navi Mumbai
Mumbai
MAHARASHTRA
410210
India |
| Phone |
9096266328 |
| Fax |
|
| Email |
gauri2903@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gauri Raman Gangakhedkar |
| Designation |
Associate Professor |
| Affiliation |
ACTREC ,TMC,Navi mumbai |
| Address |
Department of Anaesthesiology ,Critical care and Pain , Tata Memorial Centre ,ACTREC ,Navi Mumbai
Mumbai
MAHARASHTRA
410210
India |
| Phone |
9096266328 |
| Fax |
|
| Email |
gauri2903@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Indrayani Rajenimbalkar |
| Designation |
Fellow in Oncoanaesthesia and Pain |
| Affiliation |
ACTREC ,TMC,Navi mumbai |
| Address |
Department of Anaesthesiology ,Critical care and Pain , Tata Memorial Centre ,ACTREC ,Navi Mumbai
Mumbai
MAHARASHTRA
410210
India |
| Phone |
9834640572 |
| Fax |
|
| Email |
rajeindrayani@gmail.com |
|
|
Source of Monetary or Material Support
|
| Advanced Centre for Treatment Research and Education ,TMC, Kharghar |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Gauri Gangakhedkar |
Advanced Centre for Treatment Research and Education in Cancer |
Department of Anaesthesia, 7th floor , RRS building
Mumbai
MAHARASHTRA |
9096266328
gauri2903@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tata Memorial Centre Institutional Ethics Committee 3 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Records of oncology patients attending PAC for the first time for elective surgical procedures |
|
| ExclusionCriteria |
| Details |
No records will be excluded |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Identification of key factors leading to review PAC.
Validation of PAC Complexity Score to predict review PAC need.
Assessment of the data to optimize preoperative clinic workflow and patient care pathways.
|
Upto three months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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)
|
10/03/2026 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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 will begin after getting official approval from IEC . Data of participants will be collected from the PAC clinic register maintained in PAC OPD for each day . From hospital records, we will note each patient basic details, health condition, and whether they were found fit or needed another checkup. If a patient needs another PAC visit, we will note the reason and check their records for 3 months to see when they finally get fitness. If a patient doesn’t get fitness for surgery within one month of their first PAC visit, the reason for the same will be recorded. After the patient gets fitness, we will follow their record for three months to see when their surgery is actually done. If a surgery is cancelled on the scheduled day or delayed for more than a month after getting fitness ,the reason for both will be recorded . The purpose of the study is to know the factors that are leading in delay in Pre anesthesia check fitness and to expedite the process and save time as oncosurgery are time sensitive procedures . |