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

NCT06805045 | Recruiting

• 1 other identifier: AR-CRC
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rectum Cancer

Keywords

augmented reality rectal cancer

Outcome Measures

Primary Outcomes (2)

• Circumferential margin oncological positivity rate (CRM)

  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

  Baseline, at 30 days after surgery, every 3 months thereafter until 3 years after surgery

• Completeness of total mesorectal excision (TME)

  • Completeness of total mesorectal excision (TME) understood as the finding on anatomopathological examination of completely intact mesorectal fascia

  Baseline, at 30 days after surgery, every 3 months thereafter until 3 years after surgery

Study Arms (2)

Patients operated with augmented reality

ACTIVE COMPARATOR

The cohort of patients undergoing rectal surgery with the aid of augmented reality will be prospectively enrolled consecutively indicatively from 01/01/2024

Procedure: augmented reality

Patients operated without augmented reality

ACTIVE COMPARATOR

The comparison cohort will be constructed by identifying patients treated with minimally invasive rectal surgery between 1 January 2017 and 31 December 2023

Procedure: augmented reality

Interventions

augmented reality PROCEDURE

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).

Patients operated with augmented reality; Patients operated without augmented reality

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead
• University of Bologna: collaborator

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• matteo rottoli, MD

  IRCCS Azienda Osperaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

angela belvedere, MD, PHD

CONTACT

+390512144466; angela.belvedere@aosp.bo.it

matteo rottoli, MD

CONTACT

+393339042767; matteo.rottoli2@unibo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2025
• First Posted: February 3, 2025
• Study Start: May 29, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 3, 2025

Record last verified: 2025-01

Locations

IT (1)