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

Not Applicable

Completed

• Conditions: Ovarian Neoplasms; Endometrial Neoplasms
• Interventions: Procedure: Extraperitoneal laparoscopic aortic lymphadenectomy; Procedure: Transperitoneal laparoscopic aortic lymphadenectomy

• Registration Number: NCT01810874
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2013-03-12
• Study First Submitted QC: 2013-03-13
• Study First Posted: 2013-03-14
• Primary Completion: 2014-07
• Status Verified: 2015-04
• Study Completion: 2015-04
• Last Update Submitted: 2015-04-28
• Last Update Posted: 2015-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Extraperitoneal	Extraperitoneal laparoscopic aortic lymphadenectomy	Patients who where randomized to extraperitoneal laparoscopic aortic lymphadenectomy.
Transperitoneal	Transperitoneal laparoscopic aortic lymphadenectomy	Patients who where randomized to transperitoneal laparoscopic aortic lymphadenectomy.

Primary Outcome Measures

Name	Time	Method
Number of lymph nodes	After aortic lymphadenectomy is completed	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.

Secondary Outcome Measures

Name	Time	Method
Operative time	At the time of the surgery	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.
Early Postoperative complications	within 30 days after surgery	Number of patients presenting postoperative complications. This variable is also classified according to the type of adverse outcome.
Intraoperative complications	At the time of surgery	Number of patients presenting intraoperative complications. This variable is also classified according to the type of adverse outcome.
Late Postoperative complications	past 30 days after surgery	Number of patients presenting postoperative complications. This variable is also classified according to the type of adverse outcome.
Overall survival	up to 3 years	Number of patients alive after surgery.
Disease-free survival	up to 3 years	Metric: months. Period of time in which there is no appearance of the symptoms or effects of the disease.

Trial Locations

Locations (1)

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