Image-Guided Surgery In The Treatment Of Rectal Cancer (AR_CRC)

Condition(s) studied

Investigational drug(s) / intervention(s)

augmented reality: 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).

Study summary

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.

Eligibility

Primary outcome measure(s)

• Circumferential margin oncological positivity rate (CRM) — Baseline, at 30 days after surgery, every 3 months thereafter until 3 years after surgery
  Circumferential margin oncological positivity rate (CRM) (margin of healthy tissue between any neoplastic structure present in the mesorectum and the mesorectal resection margin itself, which is considered positive when less than 1 mm) measured on anatomopathological assessment of the tumour
• Completeness of total mesorectal excision (TME) — Baseline, at 30 days after surgery, every 3 months thereafter until 3 years after surgery
  • Completeness of total mesorectal excision (TME) understood as the finding on anatomopathological examination of completely intact mesorectal fascia

Trial sites (1)

More IRCCS Azienda Ospedaliero-Universitaria di Bologna trials in Italy