Department of Visceral, Thoracic and Vascular Surgery University Hospital Carl Gustav Carus Technische Universität Dresden
Dresden, Saxony, 01307, Germany
Location status: Recruiting
Recruiting
NCT Number: NCT05652361
Machine Learning-based Surgical Guidance System for Robot-assisted Rectal Surgery
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Additional visualisation of surgical assistance during surgery
OtherRobot-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 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]
Time frame: During Surgery
Time from skin incision until placement of last skin staple/suture
-
Duration of postoperative hospital stay [days]
Time frame: At day of discharge, assessed up to 5 days
Postoperative day 1 until day of discharge
-
Duration of postoperative intermediate/intensive care unit stay [days]
Time frame: At day of discharge, assessed up to 5 days
Postoperative day 1 until day of discharge
-
Frequency of peri-operative morbidity after resection
Time frame: At day of discharge, assessed of up to 5 days
Frequency of peri-operative complications after surgery until Day of Discharge
-
Kind of peri-operative morbidity after resection
Time frame: At day of discharge, assessed of up to 5 days
Kind of peri-operative complications after surgery until day of discharge
-
Assessment of the circumferential resection margin (CRM)
Time frame: At day of discharge, assessed up to 5 days
Rate of R0 resections
-
Number of resected lymphnodes
Time frame: During surgery
Number of lymphnodes resected during surgery
-
Assessment of pelvic function before and after rectal resection
Time frame: 15 months
Rectal function will be assessed preoperatively and 12-15 months postoperatively using the standard LARS score questionnaire, resulting in a score between 0 and 42. Higher scores mean a worse outcome (worse pelvic function).
-
Rectal sphincter function before and after rectal resection
Time frame: 15 months
Sphincter function will be assessed by manometry preoperatively and 12 - 15 months postoperatively
-
Assessment of the difficulty of the preparation
Time frame: 48 hours after surgery
Surgeon questionnaire, the questionnaire qualitatively assesses nine items, each item scoring from "not at all" to "very much", evaluated individually
-
Assessment of usability of guidance system
Time frame: Through study completion, an average of 6 months
One-time final survey of all participating surgeons, the questionnaire qualitatively assesses nine items, each item scoring from "not at all" to "very much", evaluated individually
Study contacts
Contact information is provided by the study sponsor or research team.
Fiona Kolbinger, Dr.
CONTACT
Marius Distler, Prof. Dr.
CONTACT
Sponsors and collaborators
Lead sponsor
Technische Universität Dresden
Other
Collaborators
- German Cancer Research Center
Registry information
Official study title
Machine Learning-based Surgical Guidance System for Robot-assisted Rectal Surgery - a First-in-human Interventional Study
Acronym: CoBot2
Important dates
- Study start
- 2026
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Dec 15, 2022
- Registry last updated
- Feb 5, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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