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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2015-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Endometrial Neoplasms Ovarian Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Transperitoneal

Patients who where randomized to transperitoneal laparoscopic aortic lymphadenectomy.

Group Type ACTIVE_COMPARATOR

Transperitoneal laparoscopic aortic lymphadenectomy

Intervention Type PROCEDURE

Aortic/para-aortic lymph nodes dissection and retrieval by transperitoneal laparoscopy; the intervention may be completed by robotic-assisted or traditional laparoscopy.

Extraperitoneal

Patients who where randomized to extraperitoneal laparoscopic aortic lymphadenectomy.

Group Type EXPERIMENTAL

Extraperitoneal laparoscopic aortic lymphadenectomy

Intervention Type PROCEDURE

Aortic/para-aortic lymph nodes dissection and retrieval by extraperitoneal laparoscopy; the intervention may be completed by robotic-assisted or traditional laparoscopy.

Interventions

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Transperitoneal 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.

Intervention Type PROCEDURE

Extraperitoneal 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.

Intervention Type PROCEDURE

Other Intervention Names

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Transperitoneal laparoscopic para-aortic lymphadenectomy Extraperitoneal laparoscopic para-aortic lymphadenectomy Retroperitoneal laparoscopic aortic lymphadenectomy Retroperitoneal laparoscopic para-aortic lymphadenectomy

Eligibility Criteria

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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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR