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
- Advanced ovarian cancer<br />Cytoreductive surgery<br />Complete cytoreduction<br />PlasmaJet<br />Hoogstadium eierstokkanker<br />Complete debulking<br />chirurgie
- Registration Number
- NL-OMON21120
- Lead Sponsor
- Erasmus MC
- Brief Summary
Submitted
- 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 multidisciplinary tumor board. 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.
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).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of complete cytoreductive surgery in the PlasmaJet versus control group with electrosurgery.
- Secondary Outcome Measures
Name Time Method 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 cytoreductive surgery<br /><br>9. Cost per complete cytoreductive surgery and per life year gained<br><br>