Endometrial Neoplasms, Ovarian Neoplasms
Conditions
Keywords
extraperitoneal, transperitoneal, laparoscopic aortic lymphadenectomy, endometrial ovarian cancer, ovarian cancer, surgical staging
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.
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
Fundación Mutua Madrileña
Hospital Universitari Vall d'Hebron Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
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 |
|---|---|---|
| Number of lymph nodes | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative complications | 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 | within 30 days after surgery | Number of patients presenting postoperative complications. This variable is also classified according to the type of adverse outcome. |
| 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. |
| Overall survival | up to 3 years | Number of patients alive after surgery. |
| Disease-free survival | up to 3 years | Metric: months. Period of time in which there is no appearance of the symptoms or effects of the disease. |
| Late Postoperative complications | past 30 days after surgery | Number of patients presenting postoperative complications. This variable is also classified according to the type of adverse outcome. |
Countries
Spain
Outcome results
None listed