Laparoscopic Robot-assisted Pelvic Exenteration for Pelvic Primary and Recurrent Cancers
Oslo University Hospital
40 participants
Nov 1, 2021
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
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Interventions
Patients with locally advanced pelvic cancer that require pelvic exenteration considered eligble, are operated minimmally invasive robot-assisted
Locations(1)
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NCT05186493