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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

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  4. What happens if I want to stop?
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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.

ClinicalTrials.gov NCT05186493