Machine Learning-based Surgical Guidance System for Robot-assisted Rectal Surgery - a First-in-human Interventional Study

Technische Universität Dresden1 site in 1 country12 target enrollmentFebruary 1, 2026

ConditionsRectum Cancer

InterventionsAdditional visualisation of surgical assistance during surgery

Overview

Phase: N/A
Intervention: Additional visualisation of surgical assistance during surgery
Conditions: Rectum Cancer
Sponsor: Technische Universität Dresden
Enrollment: 12
Locations: 1
Primary Endpoint: Incidence of discrepancies between the surgeon's preparation and the prediction of the CoBot system
Status: Recruiting
Last Updated: 2 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The aim of the study is to evaluate the technical feasibility and applicability of a surgical assistance system based on image recognition algorithms in a first-in-human pilot study. In addition, this study will provide preliminary data on the oncological outcome of the assistance system.

Registry

clinicaltrials.gov

Start Date

February 1, 2026

End Date

December 1, 2027

Last Updated

2 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Technische Universität Dresden

Responsible Party

Sponsor

Eligibility 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

Arms & Interventions

Additional visualisation of surgical assistance during surgery

Intervention: Additional visualisation of surgical assistance during surgery

Outcomes

Primary Outcomes

Incidence of discrepancies between the surgeon's preparation and the prediction of the CoBot system

Time Frame: 72 hours after Surgery

System discrepancy score quantifying major misspecifications of the CoBot system in comparison to the surgeon's action

Secondary Outcomes

Operating time [min](During Surgery)
Assessment of the difficulty of the preparation(48 hours after surgery)
Duration of postoperative hospital stay [days](At day of discharge, assessed up to 5 days)
Duration of postoperative intermediate/intensive care unit stay [days](At day of discharge, assessed up to 5 days)
Frequency of peri-operative morbidity after resection(At day of discharge, assessed of up to 5 days)
Kind of peri-operative morbidity after resection(At day of discharge, assessed of up to 5 days)
Assessment of the circumferential resection margin (CRM)(At day of discharge, assessed up to 5 days)
Number of resected lymphnodes(During surgery)
Assessment of pelvic function before and after rectal resection(15 months)
Rectal sphincter function before and after rectal resection(15 months)
Assessment of usability of guidance system(Through study completion, an average of 6 months)