'Locally advanced rectal carcinoma' and 'a rectal tumor with extension into surrounding tissues'
Conditions
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Patient signed and dated informed consent prior to study-specific screening procedures 2. Primary cT4bN0-2 locally advanced rectal cancer or recurrent rectal cancer or recurrent colonic cancer at colorectal anastomosis with radiologically (potentially) involved margins beyond the mesorectum including pelvic side wall, presacral fascia, sacrum, prostate or vesicles with an indication for resection after neoadjuvant treatment 3. Age >= 18 years
Exclusion criteria
Exclusion criteria: 1. Threatened anterior circumferential resection margin negated through the performance of a (posterior) pelvic exenteration 2. Only involvement of the wall of the vagina and/or uterus 3. Tumor involvement sacrum cranial to the junction of S2/S3 and cT4b 4. Tumor involvement of common or external iliac artery/vein 5. Tumor involvement of hypogastric artery bilaterally 6. Tumor involvement of the lumbosacral plexus, sacral nerve 1 or sacral nerve 2 7. Synchronous peritoneal metastases 8. Multifocal recurrence with more than 3 suspected localizations 9. Synchronous suspected metastases in >= 2 different organs 10. Patient operated in semi-elective or acute setting 11. Patient classified as American Society of Anaesthesiologist Class >= 4 12. Patient is unable to speak Dutch 13. Legally incapable
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary ouctome measure is the accuracy of stereotactic navigation defined by the distance between predefined anatomical landmarks that are pointed out by means of a tracked instrument by the surgeon intraoperatively (and marked on the transverse, coronal and sagittal MRI images if applicable) and the actual location of this anatomical landmark in the scan that is marked pre-operatively. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures include: the accuracy of stereotactic navigation, defined by the distance between the pre-determined anatomical reference points intraoperatively identified by the surgeon using a navigation system-calibrated instrument, and the actual location of this anatomical reference point in the scan. The results of a questionnaire assessing the user-friendliness of the navigation system are also considered as secondary outcome measures. | — |
Countries
Netherlands
Outcome results
None listed