RecruitingNot ApplicableNCT06805045

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

Image-guided Surgery in the Treatment of Rectal Cancer: the Impact of Virtual and Augmented Reality in Clinical Practice


Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Enrollment

50 participants

Start Date

May 29, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating whether augmented reality (AR) image guidance during rectal cancer surgery can improve surgical precision and patient outcomes by overlaying 3D models of the patient's anatomy onto the surgeon's view. **You may be eligible if...** - You are 18 or older - You have primary rectal cancer requiring surgery to remove it - You have not had prior rectal surgery - Your CT and MRI scans meet the technical specifications required for the study **You may NOT be eligible if...** - You have had previous rectal surgery - Your cancer has returned after prior treatment - The cancer originates in another organ and is only affecting the rectum secondarily - Your cancer has spread to the lining of the abdominal cavity (peritoneal spread) - Your surgery is intended for palliation only (symptom relief, not cure) - Your imaging was performed at a different hospital Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREaugmented 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).


Locations(1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Italy

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NCT06805045


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