oCAlly advanced and recurrent Rectal cancer NAVigationAL Surgery – A Pilot Study (CARNAVAL)
- Conditions
- ocally advanced and recurrent rectal cancer
- Registration Number
- NL-OMON28183
- Lead Sponsor
- ot applicable
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 5
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)
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method The pathological radicality of the resection as a dichotomous variable: R0 or R1/R2 resection