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

Study Status: Completed
Recruit Status: Completed
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

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 Summary:
Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Current Primary Outcome: Number of lymph nodes [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome:

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


Information By: Hospital Universitari Vall d'Hebron Research Institute

Dates:
Date Received: March 12, 2013
Date Started: June 2012
Date Completion:
Last Updated: April 28, 2015
Last Verified: April 2015