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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.
ClinicalTrials.gov, NCT05186493

Sites

  • Oslo University Hospital The Radium HospitalOslo, Norway