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).

Evaluation of effectiveness of the PlasmaJet Surgical device in the treatment of Advanced Stage Ovarian Cancer

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON21120

Enrollment

330

Registered

2017-08-16

Start date

2017-11-01

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced ovarian cancer Cytoreductive surgery Complete cytoreduction PlasmaJet Hoogstadium eierstokkanker Complete debulking chirurgie

Interventions

Use of the PlasmaJet device during cytoreductive surgery (intervention group) versus the use of standard surgical instruments combined with electrocoagulation (control group).

Eligibility

Inclusion criteria

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. -pre-operative CT scan meets criteria for resectability

Exclusion criteria

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 carboplatin paclitaxel) (assessed by medical oncologist and discussed in multidisciplinary tumor board). -patients with a non-epithelial, borderline ovarian tumour or an ovarian metastasis of another primary tumour. -patients with recurrence of ovarian cancer

Design outcomes

Primary

Measure	Time frame
Rate of complete cytoreductive surgery in the PlasmaJet versus control group with electrosurgery.	—

Secondary

Measure	Time frame
1. Complications (30-day morbidity) 2. Quality of life 3. Duration of surgery 4. Blood loss 5. Length of hospital stay 6. Disease-free survival 7. Overall survival 8. Percentage of patients who have received a colostomy to achieve complete cytoreductive surgery 9. Cost per complete cytoreductive surgery and per life year gained	—

Contacts

Public ContactGatske Nieuwenhuyzen-de Boer

Erasmus MC

placomov@erasmusmc.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)