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Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
ID06867445

Minimally Invasive Pelvic Exenteration for Recurrent or Persistent Cervical and Vaginal Cancer Assessing 3-Year Disease-Free and Overall Survival, Complications, and Quality of Life

Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2025-07-17

64

Participants Needed

1

Research Sites

156 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety of minimally invasive pelvic exenteration surgery in women with recurrent or persistent cervical or vaginal cancer located in the pelvis. This study focuses on patients eligible for pelvic exenteration according to European Society of Gynecological Oncology ESGO guidelines. The main goal is to assess disease-free survival over three years, with additional evaluation of overall survival, complication rates, and quality of life. The study involves pelvic exenteration performed using a minimally invasive approach, either robot-assisted or laparoscopic. Before surgery, patients undergo diagnostic laparoscopic assessment to rule out metastasis and preoperative imaging including MRI and PETCT scans. A mini-laparotomy up to 7 cm is allowed for reconstructive surgery. Data is collected electronically, and all patients receive surgery aiming for complete tumor removal with negative margins. Participants will be assessed with imaging scans before surgery and monitored for complications during and after the procedure. Quality of life is evaluated at multiple timepoints up to two years post-surgery. Overall survival is tracked for up to 100 months after surgery. The study requires informed consent and involves detailed follow-up to measure safety and effectiveness outcomes over several years.

CONDITIONS

Brief Title

Minimally Invasive Pelvic Exenteration in Vaginal or Cervical Cancer Recurrence

Research Team

N

Nicolò Bizzarri

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