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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Norway
Oslo University Hospital The Radium Hospital
RECRUITING
Oslo
Contact Information
Primary
Ebbe B Thorgersen, MD PhD
ebbtho@rr-research.no
+4748144121
Backup
Arne M Solbakken, MD
arne.mide.solbakken@icloud.com
+4748281082
Time Frame
Start Date: 2021-11-01
Estimated Completion Date: 2030-12-01
Participants
Target number of participants: 40
Treatments
Experimental: Locally advanced pelvic cancer that requires total pelvic exenteration
Adult patients (\>18 years) with locally advanced pelvic cancer that require pelvic exenteration considered eligible for robot- assisted minimally invasive surgery by the respective multidisciplinary teams
Related Therapeutic Areas
Sponsors
Leads: Oslo University Hospital

This content was sourced from clinicaltrials.gov