Laparoscopic Robot-assisted Pelvic Exenteration for Pelvic Primary and Recurrent Cancers

Recruiting now · Not applicable

Conditions studied: Locally Advanced Pelvic Cancer That Require Pelvic Exenteration

In brief

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.

Key facts

Study ID

NCT05186493

Run by

Oslo University Hospital

People needed

40

Starts

2021-11-01

Expected to finish

2030-12-01

Last updated by the study team

2024-04-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Any reason why the patient in the investigator's opinion is not suited for inclusion.

Where it is running

• Oslo University Hospital The Radium Hospital — Oslo, Norway (enrolling)

Full record on ClinicalTrials.gov

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