NCT03519165.

Trial name or title	Restrictive or individualized goal‐directed fluid replacement strategy in ovarian cancer cytoreductive surgery (RIGoROCS)
Methods	Study type: parallel, double‐blinded (participants, outcomes assessor) RCT Location: Kolkata, India Number of centres: 1 Duration of study: NR Follow‐up: up to approximately 2 years Protocol: NCT03519165
Participants	Inclusion criteria Cytoreductive surgery for ovarian cancer PDS: primary (chemo‐naive participants including completion staging/primary debulking and secondary cytoreduction) IDS: interval debulking surgery (after chemotherapy) American Society of Anesthesiology (ASA) score of 1 to 3 Age > 18 years and < 65 years Surgery of duration longer than 240 minutes Presumed blood loss > 500 mL Elective surgery Exclusion criteria Patient refusal Inability to give consent Laparoscopic surgery Emergency surgery, participants undergoing HIPEC Age < 18 years and > 65 years BMI > 40 Participants with LVEF < 30% Arrhythmia Acute MI (within 30 days) COPD with FEV₁ < 50% Coagulopathy (platelet < 50,000/μL, APTT > 2 × control, INR > 1.5) Significant liver dysfunction (liver enzymes > 3 × normal) Significant renal dysfunction (creatinine > 2 × normal) Psychiatric disorders Sepsis, or SIRS Hypersensitivity to gelofusine Total number of participants: NR Characteristics: NR Comorbidities, n (%): NR
Interventions	Treatment groups RFT ‐ study "control group (Group C)" ‐ intraoperative fluid therapy will include maintenance fluid and replacement of surgical loss. Aim to maintain MAP > 65 mmHg, CVP 8 to 12 cm H₂O and urine output > 0.5 mL/kg/h GDFT ‐ study "goal‐directed group (Group G)" ‐ machine‐guided fluid therapy using EV1000 (FloTrac System 4.0, Edward Lifesciences, Irvine, CA, USA), intraoperative fluid therapy will be targeted to SVV < 13%, SVI > 35 mL/m²/beat, SVRI ≥ 1900 dynes‐sec/cm‐5/m² using EV1000 FloTrac monitor in addition to clinical parameters like MAP, CVP, and urine output Concomitant treatment in both groups: NR
Outcomes	Primary outcome Postoperative length of stay (LOS) in hospital in days Secondary outcomes Cost of treatment Postoperative morbidity survey 30‐Day morbidity and mortality
Starting date	June 2016
Contact information	Jyotsna Goswami; 03366057000 ext 7179; jyotsnagoswami@gmail.com
Notes	Funding: Tata Medical Center Conflict of interest: NR

APTT: activated partial thromboplastin time.

ASA: American Society of Anesthesiology.

BMI: body mass index.

COPD: chronic obstructive pulmonary disease.

CRP: C‐reactive protein.

CVP: central venous pressure.

FEV₁: forced expiratory volume in one second.

GDFT: goal‐directed fluid therapy.

GDT: goal‐directed therapy.

HIPEC: hyperthermic intraperitoneal chemotherapy.

IDS: interval debulking surgery.

IL‐6: interleukin‐6.

INR: international normalized ratio.

LOS: length of stay.

LVEF: left ventricular ejection fraction.

MAP: mean arterial pressure.

MELD: model for end‐stage liver disease.

MI: myocardial infarction.

NR: not reported.

PDS: primary debulking surgery.

PPV: pulse pressure variation.

RCT: randomized controlled trial.

RFT: restrictive fluid therapy.

RIFLE: risk, injury, failure, loss of function, and end‐stage renal disease.

SIRS: systemic inflammatory response syndrome.

SOFA: sequential organ failure assessment.

SVI: stroke volume index.

SVRI: systemic vascular resistance index.

SVV: stroke volume variation.

TNF: tumour necrosis factor.