| CTRI Number |
CTRI/2018/02/011752 [Registered on: 07/02/2018] Trial Registered Retrospectively |
| Last Modified On: |
08/01/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Observational |
| Study Design |
Other |
|
Public Title of Study
|
increase in eosinophils- type of fighter cells in patients undergoing operation - anaesthetic management and outcome |
|
Scientific Title of Study
|
Eosinophilia in surgical patients and its impact on perioperative management |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vijaya Patil |
| Designation |
Professor |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Anaesthesia, Critical Care and Pain, Tata Memorial Hospital, E.Borges Marg, Parel, Mumbai
Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
912224451118 |
| Fax |
|
| Email |
vijayappatil@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Yadav |
| Designation |
Junior Registrar |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Anaesthesia, Critical Care and Pain, Tata Memorial Hospital, E.Borges Marg, Parel, Mumbai
Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
912224451118 |
| Fax |
|
| Email |
dr.amitblue15@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijaya Patil |
| Designation |
Professor |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Anaesthesia, Critical Care and Pain, Tata Memorial Hospital, E.Borges Marg, Parel, Mumbai
Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
912224451118 |
| Fax |
|
| Email |
vijayappatil@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
TATA MEMORIAL HOSPITAL |
| Address |
E BORGES MARG, PAREL, MUMBAI |
| 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 Vijaya Patil |
Tata Memorial Hospital |
Department of Anaesthesia, Critical care and pain,
E.Borges Marg, Parel, Mumbai 400012
Mumbai
Mumbai
MAHARASHTRA |
022-24177048
vijayappatil@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics Committee II |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
All microvascular free flaps (free radial, free fibula, free ALT, TRAM etc) done under anaesthesia , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Charts of all patients undergoing surgery in major operation theatres over a period of 1 year |
|
| ExclusionCriteria |
| Details |
Emergency surgeries |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To identify trends in our anaesthesia practice microvascular surgeries
To identify potential areas for improvement |
pre-operative assessment, intra-operative management and post-operative outcomes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To identify specific factors associated with intra- and post-operative complications |
pre-operative assessment, intra-operative management and post-operative outcomes |
|
|
Target Sample Size
|
Total Sample Size="1000"
Sample Size from India="1000"
Final Enrollment numbers achieved (Total)= "3556"
Final Enrollment numbers achieved (India)="3556" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/03/2015 |
| Date of Study Completion (India) |
30/11/2015 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/11/2015 |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
not published yet. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
We found that the incidence of eosinophilia is 9% in our study population. However it was not associated with increased incidence of perioperative complications like bronchospasm, drug reaction, haemodyanamic instability or anaphylaxis. of 319 patients with preoperative eosinophilia, postoperative eosinophil count was available in 149 patients. Of these only 20 patients had eosinophilia in immediate postoperative period (13.4%). Of 137 patients who had mild eosinophilia in preoperative period only 8 patients showed eosinophilia immediately after surgery (5.8%). Of 12 patients with hypereosinophilia in preoperative period all 12(100%) showed persistent eosinophilia postoperatively.
Thus our study shows that in cancer patients the eosinophilia is most of the time related to the pathogenesis of the cancer and not a separate disease and could be safely given anaesthesia. |