Locally advanced and recurrent rectal cancer
Conditions
Interventions
The application of stereotactic navigation combined with 3D MRI-topography during oncologic laparotomic or laparoscopic resection for locally advanced or recurrent rectal cancer.
Sponsors
None listed
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female 2. Age = 18 years 3. Primary cT4abN0-2 rectal cancer or recurrent rectal cancer with an indication for resection after neoadjuvant treatment 4. Lithotomy position during the whole procedure 5. Laparoscopic approach 6. Laparotomic approach 7. Informed consent (addendum V)
Exclusion criteria
Exclusion criteria: 1. Threatened anterior circumferential resection margin negated through the performance of a (posterior) pelvic exenteration 2. Tumor involvement sacrum cranial to the junction of S2/S3 and cT4b 3. Tumor involvement of common or external iliac artery/vein 4. Tumor involvement of hypogastric artery bilaterally 5. Tumor involvement of the lumbosacral plexus, sacral nerve 1, sacral nerve 2 or sacral nerve 3 6. Patient operated in semi-elective or acute setting 7. Inclusion in another study (randomised clinical trial) 8. Patient classified as American Society of Anaesthesiologist Class ? 4 9. Patient is unable to speak Dutch 10. Legally incapable
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study parameter is the accuracy of stereotactic navigation defined by the distance between the corresponding location in the scan when the four anatomical landmarks are pointed out by the surgeon by means of a tracked instrument and the actual location of this anatomical landmark in the scan that is marked pre-operatively. | — |
Secondary
| Measure | Time frame |
|---|---|
| The pathological radicality of the resection as a dichotomous variable: R0 or R1/R2 resection | — |
Contacts
Public ContactArthur Wijsmuller
UMCG
Outcome results
None listed