Machine Learning-based Surgical Guidance System for Robot-assisted Rectal Surgery (CoBot2)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Rectum Cancer
• Intervention / Treatment: Other: Additional visualisation of surgical assistance during surgery

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marius Distler, Prof. Dr.; Phone Number: +49 351 458 4098; Email: marius.distler@ukdd.de
• Study Contact Backup: Name: Fiona Kolbinger, Dr.; Phone Number: +49 351 458 4098; Email: fiona.kolbinger@ukdd.de

Study Locations

• Germany
  • Saxony
    • Dresden, Saxony, Germany, 01307
      • Recruiting
      • Department of Visceral, Thoracic and Vascular Surgery University Hospital Carl Gustav Carus Technische Universität Dresden
      • Contact: Marius Distler, Prof. Dr.; Email: marius.distler@ukdd.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Additional visualisation of surgical assistance during surgery	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	72 hours after Surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operating time [min]	Time from skin incision until placement of last skin staple/suture	During Surgery
Assessment of the difficulty of the preparation	Surgeon questionnaire, the questionnaire qualitatively assesses nine items, each item scoring from "not at all" to "very much", evaluated individually	48 hours after surgery
Duration of postoperative hospital stay [days]	Postoperative day 1 until day of discharge	At day of discharge, assessed up to 5 days
Duration of postoperative intermediate/intensive care unit stay [days]	Postoperative day 1 until day of discharge	At day of discharge, assessed up to 5 days
Frequency of peri-operative morbidity after resection	Frequency of peri-operative complications after surgery until Day of Discharge	At day of discharge, assessed of up to 5 days
Kind of peri-operative morbidity after resection	Kind of peri-operative complications after surgery until day of discharge	At day of discharge, assessed of up to 5 days
Assessment of the circumferential resection margin (CRM)	Rate of R0 resections	At day of discharge, assessed up to 5 days
Number of resected lymphnodes	Number of lymphnodes resected during surgery	During surgery
Assessment of pelvic function before and after rectal resection	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).	15 months
Rectal sphincter function before and after rectal resection	Sphincter function will be assessed by manometry preoperatively and 12 - 15 months postoperatively	15 months
Assessment of usability of guidance system	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	Through study completion, an average of 6 months

Collaborators and Investigators

• Sponsor: Technische Universität Dresden
• Collaborators: German Cancer Research Center
• Investigators: Principal Investigator: Marius Distler, Prof. Dr., University Hospital Carl Gustav Carus Dresden

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: December 7, 2022
• First Submitted That Met QC Criteria: December 7, 2022
• First Posted (Actual): December 15, 2022

Study Record Updates

• Last Update Posted (Actual): February 5, 2026
• Last Update Submitted That Met QC Criteria: February 2, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Robotic Surgery; Total mesorectal excision
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Rectal Diseases; Rectal Neoplasms
• Other Study ID Numbers: TUD-COBOT2-087; DE-25-00015527 (Other Identifier: DMIDS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No