Clinical trial · Interventional
Computer Navigation-assisted Surgery for Locally Advanced and Recurrent Rectal Cancer
NCT04512937CI-TRIAL-00062157NAVI-LARRCactive not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- 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 aim of this study is to investigate feasibility of computer navigation-assisted surgery in particularly difficult cases of locally advanced (LARC) and recurrent (LRRC) rectal cancer where the standard surgical strategy is expected to result in incomplete tumour removal. The investigators hypothesize that computer navigation-assisted surgery can facilitate improved anatomic orientation in the pelvis enabling tumour removal with free margins in these cases.
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 |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Computer-assisted navigation surgery | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- All patients
- description
- All patients will be subjects to the intervention of computer navigation-assisted surgery
- interventionNames
- Device: Computer-assisted navigation surgery
Primary outcomes (1)
- measure
- Rate of patients with R0 resection
- timeFrame
- 2 years
- description
- Resection status will be determined by histopathological examination of specimen
Secondary outcomes (8)
- measure
- Assessment of whether pre-procedural plan was executed during surgery by comparing pre- and post-operative magnetic resonance imaging (MRI).
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with LARC or LRRC (either biopsy verified, or demonstrated on MRI and confirmed by the MDT decision) * The MDT must deem standard surgical strategy at high risk of resulting in R1/R2 resection and computer-assisted navigation likely to improve the chances of obtaining R0 resection. * Written informed consent Exclusion Criteria: * Non-adenocarcinoma malignancies. * Unresectable distant metastatic disease or unresectable synchronous other malignancy * Patients deemed unfit to participation according to the MDT.
References
Publications (0)
Data not yet available
No reference posted for this study.