Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Endometrial Neoplasms

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Uterine Neoplasms

Uterine Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Patients who where randomized to extraperitoneal laparoscopic aortic lymphadenectomy.

Patients who where randomized to transperitoneal 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.

Extraperitoneal 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.

Transperitoneal Laparoscopic aortic lymphadenectomy

Antonio Gil Moreno, MD, PhD

Berta Diaz Feijoo, MD, PhD

Alejandro Correa Paris, MD

M. Assumpció Pérez-Benavente, MD, PhD

Silvia Franco Camps, MD

Jose Luis Sánchez Iglesias, MD, PhD

Silvia Cabrera Díaz, MD, PhD

Oriol Puig Puig, MD

Javier De La Torre, MD, PhD

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

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

STELLA 2 Trial: Staging of Endometrial and Ovarian Cancer Comparing the Transperitoneal vs. Extraperitoneal Approach for Laparoscopic Lymphadenectomy of Aortic Nodes, Evaluating 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

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.

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.

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.

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

European Regional Development Fund

Hospital Universitari Vall d'Hebron Research Institute

Transperitoneal laparoscopic aortic lymphadenectomy

Extraperitoneal laparoscopic aortic lymphadenectomy

Antonio Gil Moreno, M.D., PhD

Berta Díaz Feijoo, M.D., PhD

Jose Luis Sánchez, M.D.

Alejandro Correa Paris, M.D.

M. Assumpció Pérez-Benavente, M.D., PhD

Silvia Cabrera Díaz, M.D.

Silvia Franco Camps, M.D.

Oriol Puig Puig, M.D.

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.

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

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

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

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

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

Fundación Mutua Madrileña

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
STELLA 2 Trial: Transperitoneal vs. Extraperitoneal Approach for Laparoscopic Staging of Endometrial/Ovarian Cancer	NCT02676726	Endometrial Neo... Ovarian Neoplas...	Extraperitoneal... Transperitoneal...	18 Years - 85 Years	Hospital Universitari Vall d'Hebron Research Institute
STELLA Trial: Transperitoneal vs. Extraperitoneal Approach for Laparoscopic Staging of Endometrial/Ovarian Cancer	NCT01810874	Endometrial Neo... Ovarian Neoplas...	Transperitoneal... Extraperitoneal...	-	Hospital Universitari Vall d'Hebron Research Institute
STELLA Trial: Transperitoneal vs. Extraperitoneal Approach for Laparoscopic Staging of Endometrial/Ovarian Cancer	NCT01810874	Endometrial Neo... Ovarian Neoplas...	Transperitoneal... Extraperitoneal...	-	Hospital Universitari Vall d'Hebron Research Institute

Spots Global Cancer Trial Database for laparoscopic aortic lymphadenectomy