| CTRI Number |
CTRI/2022/02/040115 [Registered on: 08/02/2022] Trial Registered Prospectively |
| Last Modified On: |
04/02/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
PROSPECTIVE AUDIT |
| Study Design |
Other |
|
Public Title of Study
|
FASTER RECOVERY AFTER CANCER SURGERY IN CHILDREN-AN AUDIT OF OUR PRACTICE.IS THERE A SCOPE FOR IMPROVEMENT? |
|
Scientific Title of Study
|
EXPEDITED RECOVERY AFTER ONCOSURGERY IN CHILDREN-AN AUDIT OF OUR PRACTICE. IS THERE A SCOPE FOR IMPROVEMENT? |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR NAYANA AMIN |
| Designation |
PROFESSOR |
| Affiliation |
TATA MEMORIAL HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIA, CRITICAL CARE AND PAIN;
TATA MEMORIAL HOSPITAL
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9820742327 |
| Fax |
|
| Email |
drnayana.amin@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
DR NAYANA AMIN |
| Designation |
PROFESSOR |
| Affiliation |
TATA MEMORIAL HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIA, CRITICAL CARE AND PAIN;
TATA MEMORIAL HOSPITAL
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9820742327 |
| Fax |
|
| Email |
drnayana.amin@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
DR ANKITA MEDHI |
| Designation |
Junior Resident |
| Affiliation |
TATA MEMORIAL HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIA, CRITICAL CARE AND PAIN;
TATA MEMORIAL HOSPITAL
Mumbai
MAHARASHTRA
400012
India |
| Phone |
6003295237 |
| Fax |
|
| Email |
ankitamedhi.g@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Hospital,Mumbai |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Hospital |
| Address |
Dr E Borges Road
Parel,Mumbai
400012 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| DRNAYANA AMIN |
TATA MEMORIAL HOSPITAL |
Department of Anesthesia, Critical care and pain.
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 |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
MAJOR AND INTERMEDIATE GRADE ONCOSURGICAL PROCEDURES IN CHILDREN |
|
| ExclusionCriteria |
| Details |
AGE MORE THAN 12 YRS
ORTHOPEDIC ONCOSURGERIES
NEUROSURGERIES
MINOR SURGERIES( CHEMOPORT INSERTION AND REMOVAL, BIOPSIES,ETC)
PROCEDURES DONE UNDER MONITORED ANESTHESIA CARE
EMERGENCY PROCEDURES |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To see our compliance to the Expedited recovery protocol for children undergoing oncosurgery |
At the end of the study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To see the impact on the perioperative morbidity and mortality |
At the end of the study |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
10/02/2022 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
ENHANCED RECOVERY AFTER SURGERY (ERAS) is evidence based multimodal perioperative protocol focused on stress reduction and the promotion of a return to function. ERAS has been proven to lower both recovery time and postoperative complication rates while being cost-effective at the same time.Based on the few studies in literature in children undergoing gastrointestinal, urological and thoracic surgery we have developed an expedited recovery protocol for children undergoing oncosurgical procedures.Through this study, we would like to audit our current practice and see if there is any scope of improvement. It will be a prospective observational study as a part of dissertation in Tata Memorial Hospital for a period of 1 year.It will be conducted on a complete patient contact free basis- with the information being collected from the EMR and forms being filled in the OT by respective anesthetist.All pediatric patients undergoing Major and intermediate oncosurgery in TMC –from 0 to 12yrs will be included. Orthopedic surgeries, Neurosurgeries and procedures under MAC will be excluded. The aim is then to see the overall compliance to the protocols put forward; and then to analyze the impact on the overall perioperative morbidity and mortality rates- to see if there is any scope for improvement. |