Machine learning system to assist in robot-assisted surgery for rectal cancer
Machine Learning-based Surgical Guidance System for Robot-assisted Rectal Surgery - a First-in-human Interventional Study
This study is testing a new machine learning system to see if it can help surgeons perform robot-assisted surgery for rectal cancer more accurately and improve patient outcomes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Technische Universität Dresden Academic / other |
| Locations | 1 site (Dresden, Saxony) |
| Trial ID | NCT05652361 on ClinicalTrials.gov |
What this trial studies
This study evaluates a surgical guidance system that utilizes machine learning and image recognition algorithms to assist surgeons during robot-assisted rectal surgery. It aims to assess the technical feasibility and applicability of this innovative approach in a first-in-human pilot study. Additionally, the study will gather preliminary data on the oncological outcomes associated with the use of this surgical assistance system. The intervention involves enhanced visualization during surgery to potentially improve surgical precision and patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are patients with rectal cancer who are scheduled for robot-assisted rectal resection and have intact preoperative urogenital and rectal function.
Not a fit: Patients with a history of other malignant diseases within the last five years or those who have had significant prior abdominal surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this system could enhance surgical precision and improve outcomes for patients undergoing rectal cancer surgery.
How similar studies have performed: While the use of machine learning in surgical assistance is a growing field, this specific application in robot-assisted rectal surgery is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with rectal cancer scheduled for robot-assisted rectal resection * Intact preoperative urogenital/rectal function * Full capability of consent Exclusion Criteria: * Previous/Second malignant disease \<5 years before diagnosis of rectal cancer * Previous abdominal surgery, except for laparoscopic appendectomy, laparoscopic cholecystectomy or Cesarean section * Pregnant or breastfeeding women * Addiction or illness that prevent the person concerned from assessing the nature and scope of the clinical trial and its possible consequences * indication that the participant is unlikely to comply with the trial protocoll (e.g. lack of compliance) * official or court order for involuntary hospitalization
Where this trial is running
Dresden, Saxony
- Department of Visceral, Thoracic and Vascular Surgery University Hospital Carl Gustav Carus Technische Universität Dresden — Dresden, Saxony, Germany (Recruiting)
Study contacts
- Principal investigator: Marius Distler, Prof. Dr. — University Hospital Carl Gustav Carus Dresden
- Study coordinator: Marius Distler, Prof. Dr.
- Email: marius.distler@ukdd.de
- Phone: +49 351 458 4098
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.