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

Restrictive or Individualized Goal-Directed Fluid Replacement Strategy in Ovarian Cancer Surgeryâ?? A prospective randomized controlled study - RIGoROCS

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2016/04/006873

Enrollment

Registered

2016-04-26

Start date

Unknown

Completion date

Unknown

Last updated

2023-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: Stroke volume variation (SVV) (using Flotrac) guided fluid therapy: Intraoperative fluid therapy will be targeted to SVV 13%, Stroke Volume Index (SVI) 35ml/m2/ beat, Systemic Vascular

Eligibility

Inclusion criteria

Inclusion criteria: -Cytoreductive surgery for ovarian cancer- PDS: primary (chemo-naÃ¯ve 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

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 -COPD with FEV1 -Coagulopathy (platelet 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

Design outcomes

Primary

Measure	Time frame
Postoperative length of Stay (LOS) in hospital in days (till fitness to discharge)Timepoint: The day when patient will be declared fit to be discharged	—

Secondary

Measure	Time frame
1.Cost of treatment 2.Post operative morbidity survey (POMS survey): on 1,3,5 and 7th postoperative day and at discharge 3.Length of ICU stay 4.30 day morbidity & mortalityTimepoint: 1.From hospital admission to discharge for that surgical episode) 2.on 1,3,5 and 7th postoperative day and at discharge 3.Till fit to discharge from ICU 4.Upto 30 days	—

Countries

India

Contacts

Public ContactDr Jyotsna Goswami

Tata Medical Center

jyotsnagoswami@gmail.com919830327187

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026