Looking for volunteers
Laparoscopic Robot-assisted Pelvic Exenteration for Pelvic Primary and Recurrent Cancers
NCT05186493 · Oslo University Hospital · Updated 3 April 2024
- What is being tested
- robot-assisted total pelvic exenteration
- For
- Locally Advanced Pelvic Cancer That Require Pelvic Exenteration
- Kind of study
- Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
- Who can join
- Ages 18 years and older. About 40 people. The full rules are on the registry page.
- Where
- Norway
- When
- Starts or started 1 Nov 2021, ends 1 Dec 2030. Registered 11 Jan 2022.
- Results
- None posted yet.
In the researchers' words
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.
Sites
- Oslo University Hospital The Radium HospitalOslo, Norway
