No registrations found.
ID
Source
Brief title
Health condition
Locally advanced and recurrent rectal cancer
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
The pathological radicality of the resection as a dichotomous variable: R0 or R1/R2 resection
Background summary
Improvements in surgical care for locally advanced and recurrent rectal cancer patients are needed. The current rate of irradical resections is unacceptably high with up to a quarter of resections in locally advanced and half of resections in recurrent rectal cancer patients being irradical. It can be achieved with a better recognition of anatomical dissection planes, anatomical landmarks, and of the dissection margin to the tumor to optimize resection margins and to minimize iatrogenic damage. Surgical navigation systems could well improve the quality of surgery for rectal cancer as shown when used in other contexts, especially when combined with 3D MRI-topography. It is likely to improve the accuracy and efficiency of pelvic surgical procedures in which it is difficult or impossible to identify and dissect along anatomical planes, as in the case of primary rectal cancer that is advanced in or beyond the total mesorectal excision plane and recurrent rectal cancer. The aim of this pilot study is to assess whether the application of stereotactic navigation combined with 3D MRI-topography can improve the quality of laparotomic or laparoscopic surgery for locally advanced and recurrent rectal cancer.
Study objective
Image-guided surgery improves the quality of surgery for the resection of primary locally advanced and recurrent rectal cancer.
Study design
Pre-operative outpatient clinic visit, operation, admission, follow-up visits (up to 24 months postoperatively)
Intervention
The application of stereotactic navigation combined with 3D MRI-topography during oncologic laparotomic or laparoscopic resection for locally advanced or recurrent rectal cancer.
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
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
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8567 |
| Other | METC UMCG : 201900475 |