Anatomopathological Analysis of the Infundibulopelvic Ligament in Patients With Ovarian Cancer

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorComplejo Hospitalario Universitario Insular Materno Infantil

About this trial

Involvement of the infundibulopelvic ligament in ovarian cancer may be associated with decreased survival and related to paraaortic lymph node metastasis

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

◦ 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.

Disqualifiers

◦ 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.

Trial population

Patients with FIGO stage IA-IVB epithelial ovarian cancer who undergoing surgery at our center.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • resection of infundibulopelvic ligament

    Other intervention

    Therefore, this study also aims to perform bilateral infundibulopelvic ligament resection (at least 8 cm in length) during surgery for ovarian cancer patients

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: ovarian cancer patients1 intervention

Trial outcomes

Primary outcomes

1

metastasis in infundibulopelvic ligament

To analyze the percentage of infundibulopelvic ligament involvement by cancer in patients with FIGO stage IA-IVB ovarian cancer.

Time frame
Through study completion, an average of 5 year

Secondary outcomes

1

Presence of paraaortic lymph node metastasis

Evaluation of histologically positive para-aortic lymph nodes in patients with metastasis in the infundibulopelvic ligament

Time frame
Through study completion, an average of 5 year

Other outcomes

1

Disease Free Survival

Impact of infundibulopelvic ligament involvement on Disease specific survival

Time frame
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
2

Assessment of complications

Assessment of perioperative complications and site effects of infundibulopelvic ligament resection

Time frame
during surgery, at hospital discharge, day 30
3

Overall survival (OS)

Impact of infundibulopelvic ligament involvement on overall survival

Time frame
60 months

Sponsors and contacts

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