Evaluation of effectiveness of the PlasmaJet Surgical device in the treatment of Advanced Stage Ovarian Cancer. Will the use of the PlasmaJet device improve the rate of complete cytoreductive surgery for advanced stage ovarian cancer: a randomized controlled trial in The Netherlands (PlaComOv-study).

Recruiting

Conditions: ovarian cancer
Ovarian carcinoma
10038594
10029903

Registration Number: NL-OMON48869

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 330

Inclusion Criteria

- patients with epithelial ovarian, tuba or peritoneal carcinoma FIGO IIIB-IV
who are fit enough to undergo radical cytoreductive surgery as discussed in the
MDO. Patients can either be scheduled for primary cytoreduction or for interval
cytoreduction after neoadjuvant chemotherapy.
- patients should understand the patient information form and sign informed
consent.
- pre-operative CT scan meets criteria for resectability

Exclusion Criteria

- patients who are not willing to participate or not able to give their
informed consent (language barrier) and patients who are not willing to undergo
extensive surgery.
- patients who are unfit to undergo extensive surgery (assessed by
gynaecologist and anaesthesiologist and discussed in MDO).
- patients who are not fit enough to get the standard complete chemotherapy
(six cycles platinum based chemotherapy, e.g. carboplatin/paclitaxel))
(assessed by medical oncologist and discussed in MDO).
- patients with a non-epithelial, borderline ovarian tumour or an ovarian
metastasis of another primary tumour.
- patients with recurrence of ovarian cancer.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Rate of complete cytoreductive surgery in the PlasmaJet versus control group<br /><br>with electrosurgery.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Complications (30-day morbidity)<br /><br>2. Quality of life<br /><br>3. Duration of surgery<br /><br>4. Blood loss<br /><br>5. Length of hospital stay<br /><br>6. Disease-free survival<br /><br>7. Overall survival<br /><br>8. Percentage of patients who have received a colostomy to achieve complete<br /><br>cytoreductive surgery<br /><br>9. Cost per complete cytoreductive surgery and per life year gained<br /><br>10. Comparison of the completeness of surgery between both study groups<br /><br>according to an independent review of the operation field photo's.</p><br>