Laparoscopic Robot-assisted Pelvic Exenteration for Pelvic Primary and Recurrent Cancers
NCT05186493
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
Inclusion Criteria: * Adult patients (\>18 years) * locally advanced pelvic cancer that require pelvic exenteration * eligible for robot- assisted minimally invasive surgery by the respective multidisciplinary teams, may be included in the study. Exclusion Criteria: * Any reason why the patient in the investigator's opinion is not suited for inclusion.
Conditions2
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NCT05186493