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

Hospital Universitari Vall d'Hebron Research Institute208 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

208

Conditions

Endometrial Neoplasms Ovarian Neoplasms

Interventions

Extraperitoneal Laparoscopic aortic lymphadenectomyPROCEDURE

Aortic/para-aortic lymph nodes dissection and retrieval by extraperitoneal laparoscopy; the intervention may be completed by robotic-assisted or traditional laparoscopy.

Transperitoneal Laparoscopic aortic lymphadenectomyPROCEDURE

Aortic/para-aortic lymph nodes dissection and retrieval by transperitoneal laparoscopy; the intervention may be completed by robotic-assisted or traditional laparoscopy.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona

Barcelona, Spain

Outcomes

Primary Outcomes

Surgical complications

Composite outcome defined by including at least one of the following: * Total estimated blood loss \> 500 mL during surgery * Blood transfusion * Intraoperative complication classified as Dindo grade III or worse, related to the aortic lymphadenectomy * Early postoperative complication (within 30 days after surgery) classified as Dindo grade III or worse, related to the aortic lymphadenectomy * Late postoperative complication (past 30 days after surgery) classified as Dindo grade III or worse, related to the aortic lymphadenectomy * Conversion to laparotomy during the aortic lymphadenectomy * Inability to complete the aortic lymphadenectomy

Time frame: intraoperatively, within 30 days after surgery, and past 30 days after surgery up to 3 months after surgery

Secondary 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: Postoperatively (within 1 week), at the moment of histopathologic examination

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

Hospital stay

The number of days that patients stay in the hospital after surgery, measured in days from the day of the surgery to the day the patient is discharged from the hospital.

Time frame: Measured the day the patient is discharged (up to 100 days)

Overall survival

Number of patients alive after surgery.

Data from ClinicalTrials.gov

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