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NCT05186493Recruiting

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

Source: ClinicalTrials.gov · Last updated 3 Apr 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
40 (estimated)
First submitted
26 Nov 2021
Start date
1 Nov 2021
Primary completion date
1 Dec 2025
Lead sponsor
Oslo University Hospital
NCT number
NCT05186493

What you commit to

  • Study type: Interventional
  • Planned participants: 40
  • From 1 Nov 2021 to the primary completion date, 1 Dec 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

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

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Oslo University Hospital The Radium Hospital
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OsloNorwayRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.