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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief 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

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

Current Primary Outcome: Surgical complications [ Time Frame: intraoperatively, within 30 days after surgery, and past 30 days after surgery up to 3 months after surgery ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Number of lymph nodes [ Time Frame: Postoperatively (within 1 week), at the moment of histopathologic examination ]
    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.
  • 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.
  • Hospital stay [ Time Frame: Measured the day the patient is discharged (up to 100 days) ]
    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.
  • Overall survival [ Time Frame: up to 3 years after surgery ]
    Number of patients alive after surgery.
  • Disease-free survival [ Time Frame: up to 3 years after surgery ]
    Period of time in which there is no appearance of the symptoms or effects of the disease.


Original Secondary Outcome: Same as current

Information By: Hospital Universitari Vall d'Hebron Research Institute

Dates:
Date Received: October 14, 2015
Date Started: July 2014
Date Completion: December 2017
Last Updated: February 3, 2016
Last Verified: February 2016