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

NCT05186493 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-04-03

No results posted yet for this study

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.

Conditions

  • Locally Advanced Pelvic Cancer That Require Pelvic Exenteration

Interventions

PROCEDURE

robot-assisted total pelvic exenteration

Patients with locally advanced pelvic cancer that require pelvic exenteration considered eligble, are operated minimmally invasive robot-assisted

Sponsors & Collaborators

  • Oslo University Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-01
Primary Completion
2025-12-01
Completion
2030-12-01

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05186493 on ClinicalTrials.gov