RecruitingNot ApplicableNCT05186493

Laparoscopic Robot-assisted Pelvic Exenteration for Pelvic Primary and Recurrent Cancers


Sponsor

Oslo University Hospital

Enrollment

40 participants

Start Date

Nov 1, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

The Radium Hospital Oslo University Hospital Estimated date of first patient enrolled: 3rd quarter 2021 Anticipated recruitment period: 4 years Estimated date of last patient completed: 4th quarter 2025 Locally advanced pelvic cancer that requires total pelvic exenteration Expected study-specific follow-up period per patient: 5 years according to standard follow-up for this patient group Primary endpoint: R0 resection rate (circumferential resection margin \>1mm) Secondary endpoints: Rate of conversion to open surgery, peri- and postoperative complications, hospital length of stay, wound healing at 3 months follow-up, Quality of Life measured by EORTC Quality of Life Questionnaire C-30 preoperatively, at 3 months and 3 year follow-ups, disease-free survival, overall survival. Diagnosis specific endpoints. Open label observational study.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating the use of robot-assisted minimally invasive surgery for a complex procedure called pelvic exenteration — the removal of multiple pelvic organs — in patients with advanced pelvic cancers. The goal is to assess whether this approach is as safe and effective as traditional open surgery. **You may be eligible if...** - You are an adult (over 18 years old) - You have a locally advanced pelvic cancer (such as cervical, rectal, or bladder cancer) that requires pelvic exenteration - Your care team has determined you are suitable for robot-assisted minimally invasive surgery **You may NOT be eligible if...** - Your surgeon determines you are not suitable for this type of procedure for any medical reason Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURErobot-assisted total pelvic exenteration

Patients with locally advanced pelvic cancer that require pelvic exenteration considered eligble, are operated minimmally invasive robot-assisted


Locations(1)

Oslo University Hospital The Radium Hospital

Oslo, Norway

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NCT05186493