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RECRUITING
NCT06867445
NA

Minimally Invasive Pelvic Exenteration in Vaginal or Cervical Cancer Recurrence

Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

View on ClinicalTrials.gov

Summary

The aim of this clinical trial is to assess the oncologic safety of minimally invasive pelvic exenteration in patients with recurrence or persistence of cervical or vaginal cancer with pelvic location, suitable for pelvic exenteration according to the ESGO guidelines (European Society of Gynecological Oncology). The primary aim is to assess the 3-year disease-free survival (DFS). The secondary aim is to assess the 3-year overall survival (OS), the intraoperative and post-operative complication rate, and the patient's quality of life.

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

64

Start Date

2025-07-07

Completion Date

2031-03-01

Last Updated

2025-07-17

Healthy Volunteers

No

Interventions

PROCEDURE

Minimally invasive pelvic exenteration

If all criteria are met, patients are registered. The patient is enrolled before the surgery, at the time of pelvic evaluation under anaesthesia. A diagnostic laparoscopic assessment can be performed before the operation to exclude peritoneal metastasis. The experimental procedure in this protocol involves the use of a minimally invasive approach (robot-assisted or laparoscopic) for performing pelvic exenteration.

Locations (1)

Policlinico Agostino Gemelli IRCCS

Rome, Italy