Machine Learning-based Surgical Guidance System for Robot-assisted Rectal Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Additional visualisation of surgical assistance during surgery.
- Who it may be relevant to
- Registry conditions: Rectum Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Machine Learning-based Surgical Guidance System for Robot-assisted Rectal Surgery - a First-in-human Interventional Study
Overview
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.
Interventions
- Other Additional visualisation of surgical assistance during surgery
Robot-assisted anterior rectal resection using daVinci® system as CE-marked gold standard with additional visualization of surgical assistance functions based on machine learning techniques
Primary outcome measures
- Incidence of discrepancies between the surgeon's preparation and the prediction of the CoBot system [Time frame: 72 hours after Surgery]
Secondary outcome measures (11)
- Operating time [min] [Time frame: During Surgery]
- Duration of postoperative hospital stay [days] [Time frame: At day of discharge, assessed up to 5 days]
- Duration of postoperative intermediate/intensive care unit stay [days] [Time frame: At day of discharge, assessed up to 5 days]
- Frequency of peri-operative morbidity after resection [Time frame: At day of discharge, assessed of up to 5 days]
- Kind of peri-operative morbidity after resection [Time frame: At day of discharge, assessed of up to 5 days]
- Assessment of the circumferential resection margin (CRM) [Time frame: At day of discharge, assessed up to 5 days]
- Number of resected lymphnodes [Time frame: During surgery]
- Assessment of pelvic function before and after rectal resection [Time frame: 15 months]
- Rectal sphincter function before and after rectal resection [Time frame: 15 months]
- Assessment of the difficulty of the preparation [Time frame: 48 hours after surgery]
- Assessment of usability of guidance system [Time frame: Through study completion, an average of 6 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
Germany · 1 center
- Department of Visceral, Thoracic and Vascular Surgery University Hospital Carl Gustav Caru — Dresden
Identifiers
NCT: NCT05652361 · TUD-COBOT2-087 · DE-25-00015527