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Clinical Trials/CTRI/2025/02/080637
CTRI/2025/02/080637RecruitingNot Applicable

Perioperative Fluid Management in Patients Undergoing Gynaeoncology and Urooncology Surgery- Does It Affect Outcomes?

Not provided1 site in 1 country500 target enrollmentStarted: February 25, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
500
Locations
1
Primary Endpoint
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.

Study Overview

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.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18.00 Year(s) to 90.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Adult patients aged 18 years or above 2)Elective abdominal surgeries for gynaecological and urological malignancy (open as well as minimally invasive surgical procedures).

Exclusion Criteria

  • 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).

Outcomes

Primary Outcomes

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.

Time Frame: 1) Baseline - intraoperative assessment of parameters | 2) Post operative period- Daily from the day of surgery till the time of hospital discharge

Secondary Outcomes

  • 1) To study the volume & type of fluid administered.(2)Need for vasopressors if any.)

Investigators

Sponsor
Not provided
Responsible Party
Principal Investigator
Principal Investigator

Dr Nayana Amin

Tata Memorial Hospital

Study Sites (1)

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