| CTRI Number |
CTRI/2025/10/096292 [Registered on: 22/10/2025] Trial Registered Prospectively |
| Last Modified On: |
21/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Role of Fluid on after surgery effect in Plastic Reconstructive Procedures for Cancer. |
|
Scientific Title of Study
|
Impact of Intraoperative Fluid Balance on Postoperative Outcomes Following Reconstructive Procedures for Malignancies – Retrospective Cohort Study. |
| Trial Acronym |
NIL |
|
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 |
Associate professor |
| Affiliation |
Tata memorial hospital parel ,mumbai |
| Address |
Department of anesthesia ,critical care and pain,division of paediatric onco anesthesia,room no 2, anesthesia office ,second floor , main building,Dr Ernest borges marg,
Tata memorial hospital,Parel Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9820742327 |
| Fax |
22-24177057 |
| Email |
drnayana.amin@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nayana Amin |
| Designation |
Associate professor |
| Affiliation |
Tata memorial hospital parel ,mumbai |
| Address |
Department of anaesthesia,critical care and pain,division of paediatric onco anaesthesia,room no 2, anesthesia office ,second floor ,main building,Dr Ernest borges marg,
Tata memorial hospital,Parel Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9820742327 |
| Fax |
22-24177057 |
| Email |
drnayana.amin@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nayana Amin |
| Designation |
Associate professor |
| Affiliation |
Tata memorial hospital parel ,mumbai |
| Address |
Department of anaesthesia,critical care and pain,division of paediatric onco anaesthesia,room no 2 ,anaesthesia office,second floor ,main building,Dr Ernest borges marg,
Tata memorial hospital,Parel Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9820742327 |
| Fax |
22-24177057 |
| Email |
drnayana.amin@yahoo.in |
|
|
Source of Monetary or Material Support
|
| Tata memorial hospital ,Dr Ernest borges marg, parel west ,parel mumbai,400012 .Maharashtra, INDIA |
|
|
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 Nayana Amin |
Department of anesthesia critical care and pain , second floor main building Tata memorial hospital |
Dr Ernest borges marg, parel east,parel,mumbai ,Maharashtra 400012
Mumbai
MAHARASHTRA |
9820742327
2224177057
drnayana.amin@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee-1,Tata memorial centre,IEC office ,Dr E Borges marg,parel,mumbai-400 012, India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D00-D09||In situ neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients aged 18 years or above undergoing reconstructive procedures for head and neck cancer, breast cancer and bone and soft tissue .
|
|
| ExclusionCriteria |
| Details |
Local flaps
Skin graft
Reconstructive procedures in neurosurgical patients
Reconstructive procedures for abdominal malignancies (abdominal wall defects, VRAM flaps following exenteration surgery)
Missing data
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the association between intraoperative fluid balance (Volume of fluid administered- volume of fluid lost) and its impact on postoperative complications in patients undergoing reconstructive procedures following oncosurgery.. |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Incidence of postoperative complications.
To study the volume & type of fluid administered.
Need for vasopressors if any.
To identify risk factors associated with postoperative complications.
|
4 weeks |
|
|
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)
|
04/11/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This study is to find out weather the amount of fluid like saline,albumin and blood products administered during surgery has any role in any complications after plastic surgery for malignancy like re surgery ,increase duration of hospital stay ,morbidity in hospital or icu. It is a backward study. In this study we will analyse previous two years data from jan 2023 to dec 2024, based on EMR of all reconstructive surgery.Based on the result of study we will set protocol to reduce morbidity and mortality in plastic reconstructive surgery.
|