卵巢癌肿瘤细胞减灭术中限制性液体补充策略与目标导向性液体补充策略的比较（RiGoROCS）：一项随机对照试验

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

作者信息

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

机构信息

Department of Onco-Anesthesia, Tata Medical Center, 14 Major Arterial Road, Newtown, Kolkata, West Bengal, India.

Department of Gynecological Oncology, Tata Medical Center, 14 Major Arterial Road, Newtown, Kolkata, West Bengal, India.

出版信息

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

DOI:10.4103/ija.ija_489_23

PMID:38343671

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10858687/

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, 3, 5, and 7 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; = 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 ( = 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 ( = 0.100). Grade 3-5 CD morbidity was 7 (12%) in GDFT and 9 (16%) in the control group ( = 0.790).

CONCLUSION

GDFT did not confer significant benefit over restrictive fluid therapy in ovarian cancer CRS regarding hospital LOS.

摘要

背景

尽管目标导向液体治疗（GDFT）与大手术后医院内发病率降低及住院时间（LOS）缩短相关，但在卵巢癌肿瘤细胞减灭术（CRS）中尚未得到广泛研究。本研究的主要目标是术后住院时间。

方法

在这项双盲、随机对照试验中，接受择期CRS的卵巢癌患者在针对初次肿瘤细胞减灭术或间隔肿瘤细胞减灭术进行随机分组前分层，之后被随机分配接受GDFT或限制性液体治疗。主要目标是测量术后住院时间。次要结局指标包括手术治疗阶段的费用以及通过术后发病率调查（POMS）在术后第1、3、5和7天及出院时评估的术后发病率。采用Clavien-Dindo（CD）分类法评估30天发病率/死亡率。

结果

两组的中位住院时间均为7天（四分位间距（IQR）：5 - 10；P = 0.282）。GDFT组术后第3天的POMS中位数为3（IQR：2 - 5），对照组为4（IQR：2.25 - 2.75）（P = 0.625）。GDFT组的治疗费用为310907印度卢比（IQR：211,856 - 427,490印度卢比），对照组为342,468印度卢比（IQR：270,179 - 454,122印度卢比）（P = 0.100）。GDFT组3 - 5级CD发病率为7例（12%），对照组为9例（16%）（P = 0.790）。