oCAlly advanced and recurrent Rectal cancer NAVigationAL surgery - a pilot study.

Recruiting

Conditions: 'Locally advanced rectal carcinoma' and 'a rectal tumor with extension into surrounding tissues'
10017990
10017998

Registration Number: NL-OMON55156

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 10

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. Signed informed consent (addendum 15)

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 or understand Dutch
10. Legally incapable

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary ouctome measure is the accuracy of stereotactic navigation defined<br /><br>by the distance between predefined anatomical landmarks that are pointed out by<br /><br>means of a tracked instrument by the surgeon intraoperatively (and marked on<br /><br>the transverse, coronal and sagittal MRI images if applicable) and the actual<br /><br>location of this anatomical landmark in the scan that is marked<br /><br>pre-operatively.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary outcome measures are:<br /><br>- the pathological radicality of the resection as a dichotomous variable: R0 or<br /><br>R1/R2 resection<br /><br>- whether the surgeon was able to locate the preoperatively marked lesion to<br /><br>his opinion<br /><br><br /><br>The third outcome measures are a questionnaire assessing the user satisfaction<br /><br>and the functional outcome of the patient.</p><br>