Clinical trial · Interventional
Laparoscopic Robot-assisted Pelvic Exenteration for Pelvic Primary and Recurrent Cancers
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced Pelvic Cancer That Require Pelvic Exenteration | Endometrial Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| robot-assisted total pelvic exenteration | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Locally advanced pelvic cancer that requires total pelvic exenteration
- description
- 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
- interventionNames
- Procedure: robot-assisted total pelvic exenteration
Primary outcomes (1)
- measure
- Rate of R0 resection
- timeFrame
- up to three months from surgery
- description
- R0 resection in oncological surgery means resection with circumferential margin \>1mm from the tumour. R0 resection is considered as an important predictor for outcome.
Secondary outcomes (6)
- measure
- Rate of conversion from laparoscopic robot-assisted to open surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * Any reason why the patient in the investigator's opinion is not suited for inclusion.
References
Publications (0)
Data not yet available