| CTRI Number |
CTRI/2025/02/080637 [Registered on: 17/02/2025] Trial Registered Prospectively |
| Last Modified On: |
14/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Impact of Fluids On Outcomes After Cancer Surgery. |
|
Scientific Title of Study
|
Perioperative Fluid Management in Patients Undergoing Gynaeoncology and Urooncology Surgery- Does It Affect Outcomes? |
| 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 |
Professor |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Anaesthesia, Critical care and Pain, Tata Memorial Hospital, Parel, Mumbai- 400012
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, Parel, Mumbai- 400012
MAHARASHTRA
400012
India |
| Phone |
9820742327 |
| Fax |
|
| Email |
drnayana.amin@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Srishti Verma |
| Designation |
Junior Resident |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Anaesthesia, Critical care and Pain, Tata Memorial Hospital, Parel, Mumbai- 400012
Mumbai
MAHARASHTRA
400012
India |
| Phone |
8296538768 |
| Fax |
|
| Email |
srishti.verma24@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept of Anaesthesia, Critical care and Pain, Second floor, Main building Tata Memorial Hospital, Parel, Mumbai-400012 |
|
|
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 |
Tata Memorial Hospital |
Department of Anesthesia Critical care and Pain, Second floor, Main Building, Parel Mumbai 400012
Mumbai
MAHARASHTRA |
09820742327
drnayana.amin@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tata memorial centre-Institutional Ethics Committee-I (IEC-I) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C51-C58||Malignant neoplasms of female genital organs, (2) ICD-10 Condition: C64-C68||Malignant neoplasms of urinary tract, (3) ICD-10 Condition: C60-C63||Malignant neoplasms of male genital organs, (4) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
NA |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1) Adult patients aged 18 years or above
2)Elective abdominal surgeries for gynaecological and urological malignancy (open as well as minimally invasive surgical procedures). |
|
| ExclusionCriteria |
| Details |
1) Patients aged below 18 years of age
2) ASA 4 -6
3) HIPEC/NIPEC
4) Colorectal surgery
5) Patients declared inoperable after initial exploration
6) Procedure duration less than 120 mins (cystoscopies, TURBT, TURP, Orchidectomy, Inguinal lymphnode dissections, adnexectomies, diagnostic laproscopy, simple hysterectomy).
|
|
|
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 perioperative fluid balance (Volume of fluid administered- volume of fluid lost) and its impact on postoperative complications in patients undergoing surgery for gynaecological and urological malignancy. |
1) Baseline - intraoperative assessment of parameters
2) Post operative period- Daily from the day of surgery till the time of hospital discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) To study the volume & type of fluid administered.
2)Need for vasopressors if any.
3) To identify risk factors associated with postoperative complications
|
1) Baseline - intraoperative assessment of parameters
2) Post operative period- Daily from the day of surgery till the time of hospital discharge |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
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)
|
25/02/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Administration of fluids during and after the surgery for gynaecological and urological malignancy can affect the outcomes after surgery. This prospective observational study is being done to see if the amount of fluid given in the perioperative period affects postoperative outcomes in patients undergoing gynaeoncology and urooncology surgery.
All eligible patient will recieve anaesthesia according to the current standard of care. Anaesthesia and fluid management will be as per discretion of the anaesthetist conducting the case. All patients including in the study will be followed up by the study team till discharge from the hospital. All the data will be collected from the case record form and electronic medical records. No biological samples will be taken from patient. No additional hospital visits will be required.
There are no risk factors associated as this is an observational study and hence there will be no direct contact with the patient. This study would help guide in optimizing fluid management practices to improve patient care in gynaecology and urooncology surgeries. |