Robot-assisted keyhole surgery to remove the pelvic organs for advanced cancer
Tests robot-assisted keyhole removal of pelvic organs in adults with advanced pelvic cancer.
Plain-language title generated from the registry record
Registry title: Laparoscopic Robot-assisted Pelvic Exenteration for Pelvic Primary and Recurrent Cancers
Key facts
- Where
- Oslo, NorwaySee the site
Where in Norway
- Oslo University Hospital The Radium HospitalOslo, NorwayTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Oslo University Hospital
- Trial code
- NCT05186493
- Record updated
- 3 April 2024
- Original description
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 2025Read full original descriptionShow less
Laparoscopic Robot-assisted Pelvic Exenteration for Pelvic Primary and Recurrent Cancers
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.
Inclusion: 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: Any reason why the patient in the investigator's opinion is not suited for inclusion.