Ovarian neoplasms, ovarian cancer, minimal invasive surgery, laparoscopy, cytoreductive surgery, debulking. Ovariumcarcinoom, laparoscopie, minimaal invasieve chirurgie, debulking.
Conditions
Interventions
Randomization between standard diagnostic work-up or added laparoscopy.
Sponsors
University Medical Center
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 80 y; 2. Scheduled for primary cytoreductive surgery because of suspicion of having advanced ovarian cancer; 3. Signed informed consent.
Exclusion criteria
Exclusion criteria: 1. WHO performance status ≥ 3; 2. Intrahepatic metastatic disease > 1 cm; 3. Extra-abdominal metastatic disease (excl. inguinal lymph nodes or pleural fluid); 4. Imaging suggestive of: A. Peri-aortic lymphadenopathy larger than 1 cm above the level of the renal veins; B. Extensive peritoneal carcinosis at the diaphragmatic level which gives the impression that complete cytoreduction is impossible; C. Extensive bowel mesentery involvement. 5. Large immobile pelvic tumor, probably requiring bowel resection for complete debulking; 6. Contra-indication for laparoscopic surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of primary cytoreductive surgery with more than 1 cm of residual tumor. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Frequency of complete (no residual tumor) cytoreduction; 2. Frequency of less than 1 cm of residual tumor after cytoreduction; 3. Progression free survival; 4. Overall survival; 5. Morbidity; 6. Quality of life; 7. Costs. | — |
Contacts
Public ContactMarrije R. Buist
Academic Medical Center Meibergdreef 9
Outcome results
None listed