STELLA 2 Trial: Transperitoneal vs. Extraperitoneal Approach for Laparoscopic Staging of Endometrial/Ovarian Cancer (STELLA-2)

Vall d'Hebron University Hospital (HUVH)

Status

Completed

Conditions

Ovarian Neoplasms

Endometrial Neoplasms

Treatments

Procedure: Extraperitoneal Laparoscopic aortic lymphadenectomy

Procedure: Transperitoneal Laparoscopic aortic lymphadenectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT02676726

P14/1817

Details and patient eligibility

About

The purpose of this study is to determine whether or not there are more complications in the extraperitoneal compared with the transperitoneal approach for laparoscopic aortic lymphadenectomy for the surgical staging of endometrial or ovarian cancer

Enrollment

208 patients

Sex

Female

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosis of endometrial cancer confirmed by histopathological analysis (endometrial biopsy) requiring surgical staging according to FIGO (the International Federation of Gynecology and Obstetrics) recommendations
Diagnosis of ovarian cancer confirmed by histopathological analysis after an initial cystectomy or oophorectomy without suspicion of neoplasia thus requiring additional surgical staging according to FIGO recommendations

Exclusion criteria

Diagnosis of advanced endometrial cancer based on findings on imaging techniques (CT, MRI and/or PET)
Diagnosis of advanced endometrial or ovarian cancer based on intraoperative findings (e.g. peritoneal carcinomatosis at initial laparoscopy)
Patients who underwent previous aortic lymphadenectomy
Patients who received previous pelvic and/or aortic radiotherapy