Image-guided surgery improves the quality of surgery for the resection of primary locally advanced and recurrent rectal cancer.
ID
Bron
Verkorte titel
Aandoening
Locally advanced and recurrent rectal cancer
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
Image-guided surgery improves the quality of surgery for the resection of primary locally advanced and recurrent rectal cancer.
Onderzoeksopzet
Pre-operative outpatient clinic visit, operation, admission, follow-up visits (up to 24 months postoperatively)
Onderzoeksproduct en/of interventie
The application of stereotactic navigation combined with 3D MRI-topography during oncologic laparotomic or laparoscopic resection for locally advanced or recurrent rectal cancer.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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)
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL8567 |
| Ander register | METC UMCG : 201900475 |