ovarian cancer ovarian neoplasmata
Conditions
Interventions
Additional staging laparoscopy as compared to the standard conventional staging
in the selection for primary cytoreductive surgery or neoadjuvant chemotherapy
plus interval cytoreductive surgery.
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: All patients suspected of having advanced ovarian cancer between 18-80 years of age, who are scheduled to undergo primary debulking surgery, who signed informed consent
Exclusion criteria
Exclusion criteria: Contraindications for primary cytoreductive surgery, and therefore, exclusion criteria for this study will be: 1. Poor general conditions (WHO performance status >3) and age > 80 years or under 18 years. 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 carcinomatosis > 1 cm at the diaphragmatic level. 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 |
|---|---|
| Our main outcome will be the frequency of futile laparotomies e.g. suboptimal primary debulking procedures. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures will be the frequency of complete cytoreductive surgery (no residual tumor), residual tumor | — |
Countries
Netherlands
Outcome results
None listed