The PlaComOv study is a multicenter, single-blinded, randomized controlled superiority trial. The acronym “PlaComOv” already reveals the study aim: “Will the use of the PLAsmaJet® device improve the rate of COMplete cytoreductive surgery for advanced-stage OVarian cancer.”17 (link)This trial compared the rates of complete CRS of patients with advanced EOC operated with standard use of electrocoagulation (control group) versus patients operated with adjuvant use of PlasmaJet (intervention group).
Patients from four gynecological oncology centers and nine centers specialized in ovarian cancer surgery in the Netherlands were randomized to either treatment arm. All hospitals had experience in CRS. A gyneco-oncologist from one of the oncology centers was always one of the surgeons. All surgeons were trained to perform operations with the PlasmaJet by following a course where theoretical knowledge of the PlasmaJet was discussed in detail, followed by operations on laboratory animals, concluding with an exam. During the cytoreductive surgery, someone with experience with PlasmaJet was always present.
For practical reasons, randomization was performed prior to surgery. Block randomization in a 1:1 ratio to either the intervention or control group was performed, with stratification according to suspected versus proven advanced-stage EOC, primary CRS (pCRS) versus interval CRS (iCRS), presence of peritoneal carcinomatosis based on preoperative computed tomography (CT) scan, and hyperthermic intraperitoneal chemotherapy (HIPEC) procedure.
All patients provided written informed consent and were blinded to the arm for which they were selected.
Patients from four gynecological oncology centers and nine centers specialized in ovarian cancer surgery in the Netherlands were randomized to either treatment arm. All hospitals had experience in CRS. A gyneco-oncologist from one of the oncology centers was always one of the surgeons. All surgeons were trained to perform operations with the PlasmaJet by following a course where theoretical knowledge of the PlasmaJet was discussed in detail, followed by operations on laboratory animals, concluding with an exam. During the cytoreductive surgery, someone with experience with PlasmaJet was always present.
For practical reasons, randomization was performed prior to surgery. Block randomization in a 1:1 ratio to either the intervention or control group was performed, with stratification according to suspected versus proven advanced-stage EOC, primary CRS (pCRS) versus interval CRS (iCRS), presence of peritoneal carcinomatosis based on preoperative computed tomography (CT) scan, and hyperthermic intraperitoneal chemotherapy (HIPEC) procedure.
All patients provided written informed consent and were blinded to the arm for which they were selected.
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