Machine Learning-based Surgical Guidance System for Robot-assisted Rectal Surgery
ConditionRectum Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTechnische Universität Dresden
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with rectal cancer scheduled for robot-assisted rectal resection
Intact preoperative urogenital/rectal function
Full capability of consent
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Additional visualisation of surgical assistance during surgery
Other interventionRobot-assisted anterior rectal resection using daVinci® system as CE-marked gold standard with additional visualization of surgical assistance functions based on machine learning techniques
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: Additional visualisation of surgical assistance during surgeryExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of discrepancies between the surgeon's preparation and the prediction of the CoBot system
System discrepancy score quantifying major misspecifications of the CoBot system in comparison to the surgeon's action
Time frame
72 hours after SurgerySecondary outcomes
1
Operating time [min]
Time from skin incision until placement of last skin staple/suture
Time frame
During Surgery2
Duration of postoperative hospital stay [days]
Postoperative day 1 until day of discharge
Time frame
At day of discharge, assessed up to 5 days3
Duration of postoperative intermediate/intensive care unit stay [days]
Postoperative day 1 until day of discharge
Time frame
At day of discharge, assessed up to 5 days4
Frequency of peri-operative morbidity after resection
Frequency of peri-operative complications after surgery until Day of Discharge
Time frame
At day of discharge, assessed of up to 5 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Technische Universität Dresden
Lead sponsor
German Cancer Research Center
Collaborator
Source ClinicalTrials.gov