Results of the PlaComOv-study, a randomized, controlled trial in the Netherlands
Introduction/Background*The most important prognostic factor for patients with advanced-stage ovarian cancer is complete cytoreductive surgery (CRS). Standard surgical treatment with electrosurgery cannot always result in complete CRS, especially when many small metastases are found on the mesentery and intestinal surface. We investigated whether adjuvant use of the PlasmaJet® Device will help increase the complete cytoreduction rate.
Methodology 327 patients with FIGO stage IIIB-IV epithelial ovarian cancer (EOC) who underwent primary or interval CRS were assigned to either surgery with PlasmaJet (intervention) or without PlasmaJet (control group).
Primary outcome was the percentage of complete CRS. Secondary outcomes were duration of surgery, blood loss, number of bowel resections and colostomies, hospitalization, 30 day-morbidity and quality of life (QoL).
Result(s)*Complete CRS was achieved in 119 patients (75.8%) of the intervention group and in 115 patients (67.6%) of the control group (P=0.131).
A per-protocol analysis was performed in which data of 27 patients with unresectable disease were excluded, considering that the aim of the study was to examine the effectiveness of the use of the PlasmaJet in achieving CRS. Complete CRS was obtained in 85.6% in the intervention group and in 71.5% in the control group (absolute difference 14.1%, 95% confidence interval [CI], 0.047 to 0.230; P=0.005).
The number of colostomies was lower in the intervention group (6.5% versus 12.7%) but did not differ significantly (P=0.169). Patient-reported QoL six months after surgery differed between groups in favor of PlasmaJet surgery (95% CI, 0.455 to 8.350; P=0.029). Other secondary outcomes did not differ significantly.
Conclusion*The adjuvant use of the PlasmaJet during CRS for advanced stage ovarian cancer resulted in a significant higher proportion of complete CRS in patients with resectable disease and a higher QoL six months after surgery. (Funded by ZonMw, Trial Register NL62035.078.17.)
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