A clinical study to see the effects of two different methods of fluid administration (small fluid volume estimated by anaesthetist compared with volume estimated by a machine) during ovarian cancer surgery

Phase 2

Completed

• Conditions: Health Condition 1: C569- Malignant neoplasm of unspecifiedovaryHealth Condition 2: C569- Malignant neoplasm of unspecifiedovaryHealth Condition 3: null- Patients of Ovarian cancer undergoing cytoreductive surgery

• Registration Number: CTRI/2016/04/006873
• Lead Sponsor: Tata Medical center Kolkata

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-09-30
• Last Update Posted: 6 March 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 144

Inclusion Criteria

Cytoreductive surgery for ovarian cancer-

PDS: primary (chemo-naïve patients including completion staging/ primary debulking and secondary cytoreduction)

IDS: interval debulking surgery (after chemotherapy)

-American Society of Anesthesiology (ASA-PS) score of 1 â?? 3

-Age more than 18 years and less than 65 years

-Surgery of duration more than 240 minutes

-Presumed blood loss more than 500 ml

-Elective surgery

Exclusion Criteria

-Patient refusal

-Inability to give consent

-Laparoscopic surgery, Emergency surgery, patients undergoing HIPEC

-Age younger than 18 years & more than 65 yrs, BMI > 40

-Patients with LVEF < 30%, Arrhythmia, Acute MI (within 30 days)

-COPD with FEV1 < 50%

-Coagulopathy (platelet <50000/μL, aPTT > x2 control, INR >1.5)

-Significant liver dysfunction (liver enzymes >x3 times normal)

-Significant renal dysfunction (creatinine >x2 times normal)

-Psychiatric disorders

-Sepsis or SIRS

-Hypersensitivity to Gelofusine

Study & Design

• Study Type: Interventional
• Study Design: Not specified