Clinical trial Recruiting at 1 site Interventional Ages 18 to 80

Using augmented reality to assist in rectal cancer surgery

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

Run by IRCCS Azienda Ospedaliero-Universitaria di Bologna · NCT06805045 · Data updated 2026-11-12

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

Study typeInterventional
Ages18 Years to 80 Years
SexAll
Enrollment50 (estimated)
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna
Academic / other
Locations1 site (Bologna)
StatusRecruiting
StartedMay 29, 2024
Main results expectedOctober 1, 2026
Study endsDecember 31, 2027
Registry record updatedFebruary 3, 2025
Trial IDNCT06805045 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include adults aged 18 and older who require radical surgery for primary rectal cancer.

Probably not a fit

Patients who have previously undergone rectal surgery or have other pelvic organ neoplasms may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: Other studies have shown promise in using augmented reality for surgical guidance, indicating potential success for this novel approach.

Who can join: the full rules

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 it's running

  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.