Using augmented reality to assist in rectal cancer surgery
Image-guided Surgery in the Treatment of Rectal Cancer: the Impact of Virtual and Augmented Reality in Clinical Practice
NA · IRCCS Azienda Ospedaliero-Universitaria di Bologna · NCT06805045
This study is testing if using augmented reality during rectal cancer surgery can help doctors see better and perform the surgery more effectively.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna (other) |
| Locations | 1 site (Bologna) |
| Trial ID | NCT06805045 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance minimally invasive surgical procedures for rectal cancer by integrating image-guided surgery tools that utilize augmented reality (AR). The approach involves overlaying preoperative 3D anatomical models onto real-time surgical images during robotic-assisted and laparoscopic surgeries. AI algorithms will be developed to improve the visibility of surgical instruments, thereby optimizing the surgical view. The pilot phase includes creating 3D virtual reconstructions of the pelvis and rectum to assess the feasibility of this technology in complex surgical anatomy.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who require radical surgery for primary rectal cancer.
Not a fit: Patients who have previously undergone rectal surgery or have other pelvic organ neoplasms may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve surgical outcomes and reduce complications for patients undergoing rectal cancer surgery.
How similar studies have performed: Other studies have shown promise in using augmented reality for surgical guidance, indicating potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bologna
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna, Italy (RECRUITING)
Study contacts
- Principal investigator: matteo rottoli, MD — IRCCS Azienda Osperaliero-Universitaria di Bologna
- Study coordinator: angela belvedere, MD, PHD
- Email: angela.belvedere@aosp.bo.it
- Phone: +390512144466
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Rectum Cancer, augmented reality rectal cancer