Hypothesis:Using PlasmaJet Surgical Device during surgery improves the rate of complete cytoreductive surgery in women with advanced ovarian cancer.Primary research question:Does the use of PlasmaJet technique result in an increased number of…
ID
Source
Brief title
Condition
- Reproductive neoplasms female malignant and unspecified
- Obstetric and gynaecological therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Rate of complete cytoreductive surgery in the PlasmaJet versus control group
with electrosurgery.
Secondary outcome
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
10. Comparison of the completeness of surgery between both study groups
according to an independent review of the operation field photo's.
Background summary
The most important goal for surgery of advanced stage ovarian cancer is removal
of all visible tumour in the abdomen, since removal of all tumour is associated
with a prolonged survival. This is called complete cytoreductive surgery (CCS).
With conventional surgical methods (electrosurgery) often, it is not possible
to remove all visible tumour in case of many small metastases on the peritoneum
and intestinal surface. In this research proposal we want to investigate
whether the use of PlasmaJet Surgical Device increases the rate of a successful
CCS, resulting in a longer progression free and overall survival.
Study objective
Hypothesis:
Using PlasmaJet Surgical Device during surgery improves the rate of complete
cytoreductive surgery in women with advanced ovarian cancer.
Primary research question:
Does the use of PlasmaJet technique result in an increased number of complete
cytoreductive surgery compared with conventional surgery using traditional
electrosurgery in case of advanced stage ovarian cancer?
Secondary research questions:
1. Are there differences in the complication rate (30-day morbidity) between
the PlasmaJet versus conventional surgery group?
2. Are there differences in quality of life after surgery with PlasmaJet versus
conventional surgery?
3. Are there surgical technical differences (duration of surgery), blood loss,
hospital stay, percentage of patients who require a colostomy to achieve
complete cytoreductive surgery) between PlasmaJet versus conventional surgery
group?
4. Is it of additional value to make operation field photo*s to have an
independent judgment of completeness of surgery?
5. Are there any long-term differences in disease-free survival and overall
survival between the PlasmaJet versus conventional surgery group?
Study design
Multicentre single-blinded superiority RCT in 3 university and 10
non-university hospitals.
Intervention
Use of the PlasmaJet device during cytoreductive surgery (intervention group)
versus the use of standard surgical instruments combined with
electrocoagulation (control group).
Study burden and risks
In literature, the risks of using the new PlasmaJet technique seem to be
negligible, but its efficacy has never been analysed in ovarian cancer surgery.
The burden of participating women is minimal: no additional follow-up visits
are necessary compared to the current standard care. They only have to fill in
7 QoL forms in 4 years even as the women in the control group.
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL62035.078.17 |
| OMON | NL-OMON21120 |