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

Summary

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

Conditions

• Endometrial Neoplasms
• Ovarian Neoplasms

Interventions

PROCEDURE

Extraperitoneal Laparoscopic aortic lymphadenectomy

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

PROCEDURE

Transperitoneal Laparoscopic aortic lymphadenectomy

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

Sponsors & Collaborators

• European Regional Development Fund

  collaborator OTHER

• Hospital Universitari Vall d'Hebron Research Institute

  lead OTHER

Principal Investigators

• Antonio Gil Moreno, MD, PhD · Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona

• Berta Diaz Feijoo, MD, PhD · Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona

• Alejandro Correa Paris, MD · Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona

• M. Assumpció Pérez-Benavente, MD, PhD · Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona

• Silvia Franco Camps, MD · Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona

• Jose Luis Sánchez Iglesias, MD, PhD · Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona

• Silvia Cabrera Díaz, MD, PhD · Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona

• Oriol Puig Puig, MD · Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona

• Javier De La Torre, MD, PhD · Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-07-31

Primary Completion

2019-09-30

Completion

2019-09-08

Countries

• Spain

Study Locations