Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05186493

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

Led by Oslo University Hospital · Updated on 2024-04-03

40

Participants Needed

1

Research Sites

473 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients older than 18 years
  • Locally advanced pelvic cancer requiring pelvic exenteration
  • Eligible for robot-assisted minimally invasive surgery by the multidisciplinary team
Not Eligible

You will not qualify if you...

  • Any reason the investigator believes the patient is not suitable for inclusion

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Oslo University Hospital The Radium Hospital

Oslo, Norway

Actively Recruiting

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Research Team

E

Ebbe B Thorgersen, MD PhD

CONTACT

A

Arne M Solbakken, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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