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

Jyotsna Goswami; Angshuman Rudra Pal; Suparna Mitra Barman; Anshuman Sarkar; Viplab Patro; Jaydip Bhowmik; Asima Mukhopadhyay

doi:10.4103/ija.ija_489_23

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

Indian J Anaesth. 2023 Dec;67(12):1101-1109. doi: 10.4103/ija.ija_489_23. Epub 2023 Dec 13.

Authors

Jyotsna Goswami¹, Angshuman Rudra Pal¹, Suparna Mitra Barman¹, Anshuman Sarkar¹, Viplab Patro¹, Jaydip Bhowmik², Asima Mukhopadhyay³

Affiliations

¹ Department of Onco-Anesthesia, Tata Medical Center, 14 Major Arterial Road, Newtown, Kolkata, West Bengal, India.
² Department of Gynecological Oncology, Tata Medical Center, 14 Major Arterial Road, Newtown, Kolkata, West Bengal, India.
³ Director, Kolkata Gynecological Oncology Trials and Translational Research Group, DD 92, Street No 271, Newtown AA-1, Kolkata, West Bengal, India.

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 1^st, 3^rd, 5^th, and 7^th 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.

Keywords: Cost; cytoreductive surgery; goal-directed fluid therapy; length of stay; ovarian cancer; post-operative morbidity; post-operative outcome; quality of life.