Endometrial Neoplasms, Ovarian Neoplasms
Conditions
Keywords
extraperitoneal, transperitoneal, laparoscopic aortic lymphadenectomy, endometrial cancer, ovarian cancer, surgical staging
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
Interventions
Aortic/para-aortic lymph nodes dissection and retrieval by extraperitoneal laparoscopy; the intervention may be completed by robotic-assisted or traditional laparoscopy.
Aortic/para-aortic lymph nodes dissection and retrieval by transperitoneal laparoscopy; the intervention may be completed by robotic-assisted or traditional laparoscopy.
Sponsors
European Regional Development Fund
Hospital Universitari Vall d'Hebron Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical complications | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of lymph nodes | 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 | 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 | 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 | up to 3 years after surgery | Number of patients alive after surgery. |
| Disease-free survival | up to 3 years after surgery | Period of time in which there is no appearance of the symptoms or effects of the disease. |
Countries
Spain
Outcome results
None listed