Ovarian Adenocarcinoma, Ovarian Cancer, Ovarian Cancer (OvCa)
Conditions
Brief summary
Involvement of the infundibulopelvic ligament in ovarian cancer may be associated with decreased survival and related to paraaortic lymph node metastasis
Interventions
OTHERresection of infundibulopelvic ligament
Therefore, this study also aims to perform bilateral infundibulopelvic ligament resection (at least 8 cm in length) during surgery for ovarian cancer patients
Sponsors
Complejo Hospitalario Universitario Insular Materno Infantil
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ◦ Patients with epithelial ovarian cancer, including high- and low-grade serous, high- and low-grade endometrioid, mucinous (expansile and infiltrative types), and carcinosarcoma. * FIGO 2014 stage IA-IVB. * Patients undergoing primary surgery or interval surgery after 3-4 or 6 cycles of chemtherapy * Patients with no residual disease after surgery. * Patients with ECOG performance status 0-1.
Exclusion criteria
* ◦ Patients without epithelial ovarian cancer. * Patients with ECOG 2-4. * Patients who do not consent to participate in the study. * Patients who did not undergo complete staging surgery (including hysterectomy, bilateral salpingo-oophorectomy, pelvic and para-aortic lymphadenectomy, and omentectomy) or with residual disease after cytoreductive surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| metastasis in infundibulopelvic ligament | Through study completion, an average of 5 year | To analyze the percentage of infundibulopelvic ligament involvement by cancer in patients with FIGO stage IA-IVB ovarian cancer. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Presence of paraaortic lymph node metastasis | Through study completion, an average of 5 year | Evaluation of histologically positive para-aortic lymph nodes in patients with metastasis in the infundibulopelvic ligament |
Other
| Measure | Time frame | Description |
|---|---|---|
| Disease Free Survival | 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 months, 27 months, 30 months, 33 months, 36 months, 42 months, 48 months, 54 months, 60 months | Impact of infundibulopelvic ligament involvement on Disease specific survival |
| Assessment of complications | during surgery, at hospital discharge, day 30 | Assessment of perioperative complications and site effects of infundibulopelvic ligament resection |
| Overall survival (OS) | 60 months | Impact of infundibulopelvic ligament involvement on overall survival |
Countries
Spain
Contacts
Primary Contactbeatriz NAVARRO SANTANA, pHD
Outcome results
None listed