Restrictive versus goal-directed fluid replacement strategy in ovarian cancer cytoreductive surgery (RiGoROCS): A randomised controlled trial

Abstract

Background: Although goal-directed fluid therapy (GDFT) is associated with reduced morbidity and length of stay (LOS) in the hospital after major surgery, it has not been widely studied in ovarian cancer cytoreductive surgery (CRS). The primary objective of the study was post-operative LOS. Methods: In this double-blind, randomised controlled trial, ovarian cancer patients undergoing elective CRS were randomised to receive either GDFT or restrictive fluid therapy after pre-randomisation stratification for primary debulking surgery or interval debulking surgery. The primary objective was to measure post-operative LOS in the hospital. Secondary outcome measures were the cost of surgical treatment episode and post-operative morbidity assessed by post-operative morbidity survey (POMS) on the 1st, 3rd, 5th, and 7th post-operative day and at discharge. Clavien–Dindo (CD) classification was used to assess the 30-day morbidity/mortality rate. Results: Median LOS was 7 days (interquartile range (IQR): 5–10; P = 0.282) in both groups. Median POMS at day 3 was 3 (IQR: 2–5) in the GDFT and 4 (IQR: 2.25–2.75) in the control groups (P = 0.625). The cost of treatment was INR 310907 (IQR: INR 211,856–427,490) in the GDFT group and INR 342,468 (IQR: INR 270,179-454,122) in the control group (P = 0.100). Grade 3–5 CD morbidity was 7 (12%) in GDFT and 9 (16%) in the control group (P = 0.790). Conclusion: GDFT did not confer significant benefit over restrictive fluid therapy in ovarian cancer CRS regarding hospital LOS.