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

NCT01810874CompletedNAINTERVENTIONAL

Summary

The purpose of this study is to determine whether the extraperitoneal approach is better than the transperitoneal approach for laparoscopic aortic lymphadenectomy for the surgical staging of endometrial or ovarian cancer.

Key Facts

Lead Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Enrollment

60

Start Date

2012-06-01

Completion Date

2014-07-01

Study Type

INTERVENTIONAL

Official Title

STELLA Trial: Staging of Endometrial and Ovarian Cancer Comparing the Transperitoneal vs. Extraperitoneal Approach for Laparoscopic Lymphadenectomy of Aortic Nodes

Interventions

Transperitoneal laparoscopic aortic lymphadenectomyExtraperitoneal laparoscopic aortic lymphadenectomy

Conditions

Endometrial NeoplasmsOvarian Neoplasms

Eligibility

Sex

FEMALE

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

Outcome Measures

Primary Outcomes

Number of lymph nodes

The number of lymph nodes (absolute number) is specified by the pathologist on histopathological analysis of the sample sent by the surgeon after surgical staging is realized (laparoscopic aortic lymphadenectomy). This variable is subdivided into: supra-mesenteric and infra-mesenteric.

Time frame: After aortic lymphadenectomy is completed

Secondary Outcomes

Operative time

Total duration of surgery (from initial skin incision to end of skin suture), and total aortic lymphadenectomy time (time spent since the beginning of aortic lymphadenectomy to its completion). Metric: minutes.

Time frame: At the time of the surgery

Intraoperative complications

Number of patients presenting intraoperative complications. This variable is also classified according to the type of adverse outcome.

Time frame: At the time of surgery

Early Postoperative complications

Number of patients presenting postoperative complications. This variable is also classified according to the type of adverse outcome.

Time frame: within 30 days after surgery

Late Postoperative complications

Number of patients presenting postoperative complications. This variable is also classified according to the type of adverse outcome.

Time frame: past 30 days after surgery

Overall survival

Number of patients alive after surgery.

Time frame: up to 3 years

Disease-free survival

Metric: months. Period of time in which there is no appearance of the symptoms or effects of the disease.

Time frame: up to 3 years

Locations

Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona, Bacelona, Spain

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