| CTRI Number |
CTRI/2015/01/005462 [Registered on: 23/01/2015] Trial Registered Retrospectively |
| Last Modified On: |
23/01/2015 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Audit on coplications following cancer surgery in children. |
|
Scientific Title of Study
|
Audit on perioperative mortality and morbidity in pediatric patients undergoing oncosurgical procedures. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Project no 1354 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nayana Amin |
| Designation |
Associate Professor |
| Affiliation |
Tata Memorial Centre |
| Address |
Department of Anaesthesia, Critical Care and Pain, Tata Memorial Centre, Dr E borges Marg, Parel, Mumbai-400012
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9820742327 |
| Fax |
|
| Email |
drnayana.amin@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Renuka Purohit |
| Designation |
PG student |
| Affiliation |
Tata Memorial Centre |
| Address |
Department of Anaesthesia, Critical Care and Pain, Tata Memorial Centre, Dr E borges Marg, Parel, Mumbai-400012
Mumbai
MAHARASHTRA
400012
India |
| Phone |
|
| Fax |
|
| Email |
renuka.purohit@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nayana Amin |
| Designation |
Associate Professor |
| Affiliation |
Tata Memorial Centre |
| Address |
Department of Anaesthesia, Critical Care and Pain, Tata Memorial Centre, Dr E borges Marg, Parel, Mumbai-400012
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9820742327 |
| Fax |
|
| Email |
drnayana.amin@yahoo.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Tata Memorial Centre |
| Address |
Department of Anaesthesia Critical care and pain, Tata Memorial Hospital, Dr E Borges Marg, Parel, Mumbai-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 Nayana Amin |
Tata Memorial Centre |
Department of anaesthesia, Critical Care and Pain, Tata Memorial Centre, Dr E Borges Marg, Parel, Mumbai-400012
Mumbai
MAHARASHTRA |
9820742327
drnayana.amin@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
All patients upto 12 years of age undergoing oncosurgical procedures under anaesthesia., |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
All patients upto 12 years of age undergoing oncosurgical procedires under anaesthesia |
|
| ExclusionCriteria |
| Details |
All patients above 12 years of age
Children undergoing daycare procedures |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Does a pediatric anaesthesiologist make a difference to perioperative outcomes in pediatric patients undergoing oncosurgical procedures |
During intraoperative period, Postoperatively till discharge from recovery/ICU and Hospital discharge. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Incidence of perioperative morbidity and mortality in pediatric patients undergoing oncosurgical procedure.
To study the implications of anaesthetic management on postsurgery outcomes in pediatric patients
To study the impact of anaesthetic management on duration of ICU stay
Duration of hospital stay Readmission rates to ICU and resurgery and re exploration rates. |
During conduct of anaesthesia untill discharge from ICU and during hospital discharge |
|
|
Target Sample Size
|
Total Sample Size="1500"
Sample Size from India="1500"
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)
|
01/01/2010 |
| 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="4"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Children have different anatomy and physiology as compared to adults hence anaesthetic consideration and implications vary in children as compared to adults. Anaesthesia itself has the potential to cause changes in physiology which could lead to morbidity and mortality. as a result of this anaesthesia management in pediatric patients can be very challenging. Pediatric anaesthesiologist have been specially trained in the anaesthesia management of infants and children. In our institute we have a team of pediatric anaesthesiologist who provide anaesthesia for most of the pediatric oncosurgical patients. we would like to conduct this audit to see if a dedicated pediatric anaesthesiologist makes a difference to the perioperative outcome in children undergoing oncosurgical procedures. This audit would also help us to know the quality of anaesthetic management and its implications and take necessary preventive of corrective measures. |