Image-Guided Surgery In The Treatment Of Rectal Cancer (AR_CRC)
Recruiting · NCT06805045 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The proposed study is addressed to introduce new Image-Guided Surgery (IGS) tools to assist mini-invasive surgical procedures of anterior rectal resection (TME; TA-TME, TTSS) performed with laparoscopic or robotic procedure. In details, the idea is to provide augmented reality (AR) guidance during robotic-assisted and laparoscopic surgeries, by overlaying the preoperative 3D virtual anatomical models to intraoperative surgical images (3D AR guidance). To optimize the intraoperative view during the 3D AR guidance, AI-based algorithms will be developed to allow the real time detection and segmentation of surgical instruments, needed to provide instrument de-occlusion during AR robotic surgery. We use 3D modelling technology in surgical planning (7 case) and intra-operative navigation ( 2 cases). The pilot study focused to 3D virtual reconstruction of the pelvis, rectum and neurovascular structure to the test the feasibility of virtual reality to this type of anatomy. Implementation of reconstruction using 3D nerve sequence (3 Tesla MRI) was used for the last 3 cases. After the creation of a complete virtual model of pelvis and its structures the last two models were applied in the operating-room during a laparoscopic rectal resection with the ausilium of AI. The test has showed good results: a good overlap of the 3D structures to the real organs of the pelvis. The focus of this research was on developing support tools aimed at enhancing surgical safety. AR can assist surgeons in identifying vascular and nerve structures that are not always clearly visible during minimally invasive procedures, compensating for the lack of tactile perception and thereby improving overall surgical safety. The next step of the study is to evaluate its benefits and limitations in clinical practice to reduce the post-operative complications and oncological recurrence.
Who can take part
Inclusion criteria
- Indication for radical transabdominal surgery for primary rectal cancer
- Resection and anastomosis or abdominal-perineal amputation surgery
- Signature of informed consent
- Patient's age ≥18 years.
- CT images acquired in the arterial venous and urographic phase with section thickness:1.25/2.5 mm, level range:0.8/0.2 mm.
- Pelvic MRI images acquired with section thickness of 1.5 mm or images acquired with 3 tesla MRI.
Exclusion criteria
- Patients who have already undergone previous rectal surgery
- Relapse of previous rectal neoplasm
- Neoplasm located in other pelvic organs, infiltrating the rectum
- Indication for endoscopic or transanal treatment
- Disease with peritoneal localisation (carcinosis)
- Surgery for palliative purposes
- Imaging performed elsewhere
Where it is running
1 location listed.
- IRCCS Azienda Ospedaliero-Universitaria di Bologna - Bologna, Italy