Image-guided Surgery in the Treatment of Rectal Cancer: the Impact of Virtual and Augmented Reality in Clinical Practice
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Circumferential margin oncological positivity rate (CRM)
Study Overview
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.
Detailed Description
In Italy, colorectal cancers account for 13% of newly diagnosed cancers per year, making it the third most frequent neoplasm in men (after lung and prostate cancers) and the second most frequent in women (after breast cancer); the second most frequent in terms of mortality in both sexes. Of these, about 30% can be traced to a rectal location .
Although over the years there has been a progressive development in chemo-radiotherapy and the introduction of new procedures and increasingly conservative protocols, to date demolitive surgery represents the gold standard in the radical treatment of rectal neoplasms, despite being one of the most complex operations to be performed in high-volume centres.
Surgical outcomes have improved considerably over the last 20 years due to the introduction of total mesorectal excision (TME), which consists of the complete removal of the mesorectum (the lymphoadipose tissue surrounding the rectum) while preserving the pelvic nerve plexuses. Despite improvements in preoperative staging, knowledge of anatomy, and the introduction of neo-adjuvant therapy, the recurrence rate of rectal cancer and postoperative genitourinary dysfunction still remains high. In recent years, there is an increasing interest in image-guided surgery (IGS) to improve the effectiveness of surgery and postoperative outcomes.
Primary objective:
To test whether the use of virtual and augmented reality, based on virtual reality reconstructions, during minimally invasive surgery for rectal cancer can allow a reduction in circumferential margin oncology positivity rates and an increase in the completeness of total mesorectal excision, thus representing an overall improvement in technical-surgical efficacy compared to the approach without augmented reality.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Patients operated without augmented reality
The comparison cohort will be constructed by identifying patients treated with minimally invasive rectal surgery between 1 January 2017 and 31 December 2023
Intervention: augmented reality (Procedure)
Patients operated with augmented reality
The cohort of patients undergoing rectal surgery with the aid of augmented reality will be prospectively enrolled consecutively indicatively from 01/01/2024
Intervention: augmented reality (Procedure)
Outcomes
Primary Outcomes
Circumferential margin oncological positivity rate (CRM)
Time Frame: 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)
Time Frame: 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
Secondary Outcomes
No secondary outcomes reported