Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06805045 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated February 3, 2025 (before its estimated October 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Minor Study First Submitted
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.
Trial Details
NCT Number NCT06805045
Lead Sponsor IRCCS Azienda Ospedaliero-Universitaria di Bologna
Collaborators: University of Bologna
Conditions
(from sponsor)
Rectum Cancer
Related terms Rectal Neoplasms
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov