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

Primary Purpose

Rectum Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Additional visualisation of surgical assistance during surgery
Sponsored by
Technische Universität Dresden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Rectum Cancer focused on measuring Robotic Surgery, Total mesorectal excision

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 appendectomy, cholecystectomy or Cesarean section

Sites / Locations

  • Department of Visceral, Thoracic and Vascular Surgery University Hospital Carl Gustav Carus Technische Universität DresdenRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Additional visualisation of surgical assistance during surgery

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Operating time [min]
Time from skin incision until placement of last skin staple/suture
Duration of postoperative hospital stay [days]
Postoperative day 1 until day of discharge
Duration of postoperative intermediate/intensive care unit stay [days]
Postoperative day 1 until day of discharge
Assessment of pelvic function before and after rectal resection
Rectal and urogenital function will be assessed preoperatively and 12-24 months postoperatively using the PERIFUNC score questionnaire, resulting in a score between 0 and 120. Higher scores mean a worse outcome (worse pelvic function).
Rectal sphincter function before and after rectal resection
Sphincter function will be assessed by manometry preoperatively and 12 - 24 months postoperatively
Frequency of peri-operative morbidity after resection
Frequency of peri-operative complications after surgery
Kind of peri-operative morbidity after resection
Kind of peri-operative complications after surgery
Assessment of usability of guidance system
Surgeon questionnaire, the questionnaire qualitatively assesses nine items, each item scoring from "not at all" to "very much", evaluated individually
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
Assessment of oncological outcomes: Frequency of Overall survival (OS)
The overall survival of all patients is assessed between operation date to date of death of any cause
Assessment of oncological outcomes: Frequency of Progression Free survival (PFS)
The progression free survival of all patients is assessed between operation date to date of tumor progression
Assessment of oncological outcomes: Frequency of Loco-Regional Tumor Free Survival (LRFS)
The Loco-Regional Tumor Free Survival of all patients is assessed between operation date to date of local tumor relapse

Full Information

First Posted
December 7, 2022
Last Updated
December 7, 2022
Sponsor
Technische Universität Dresden
Collaborators
Deutsches Krebsforschungszentrum (DKFZ)
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1. Study Identification

Unique Protocol Identification Number
NCT05652361
Brief Title
Machine Learning-based Surgical Guidance System for Robot-assisted Rectal Surgery
Acronym
CoBot2
Official Title
Machine Learning-based Surgical Guidance System for Robot-assisted Rectal Surgery - a First-in-human Interventional Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 19, 2021 (Actual)
Primary Completion Date
July 31, 2026 (Anticipated)
Study Completion Date
April 30, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Technische Universität Dresden
Collaborators
Deutsches Krebsforschungszentrum (DKFZ)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectum Cancer
Keywords
Robotic Surgery, Total mesorectal excision

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Additional visualisation of surgical assistance during surgery
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Additional visualisation of surgical assistance during surgery
Intervention Description
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 Measure Information:
Title
Incidence of discrepancies between the surgeon's preparation and the prediction of the CoBot system
Description
System discrepancy score quantifying major misspecifications of the CoBot system in comparison to the surgeon's action
Time Frame
72 hours after Surgery
Secondary Outcome Measure Information:
Title
Operating time [min]
Description
Time from skin incision until placement of last skin staple/suture
Time Frame
During Surgery
Title
Duration of postoperative hospital stay [days]
Description
Postoperative day 1 until day of discharge
Time Frame
At day of discharge, assessed up to 90 days
Title
Duration of postoperative intermediate/intensive care unit stay [days]
Description
Postoperative day 1 until day of discharge
Time Frame
At day of discharge, assessed up to 90 days
Title
Assessment of pelvic function before and after rectal resection
Description
Rectal and urogenital function will be assessed preoperatively and 12-24 months postoperatively using the PERIFUNC score questionnaire, resulting in a score between 0 and 120. Higher scores mean a worse outcome (worse pelvic function).
Time Frame
24 months
Title
Rectal sphincter function before and after rectal resection
Description
Sphincter function will be assessed by manometry preoperatively and 12 - 24 months postoperatively
Time Frame
24 months
Title
Frequency of peri-operative morbidity after resection
Description
Frequency of peri-operative complications after surgery
Time Frame
24 months
Title
Kind of peri-operative morbidity after resection
Description
Kind of peri-operative complications after surgery
Time Frame
24 months
Title
Assessment of usability of guidance system
Description
Surgeon questionnaire, the questionnaire qualitatively assesses nine items, each item scoring from "not at all" to "very much", evaluated individually
Time Frame
48 hours after surgery
Title
Assessment of the difficulty of the preparation
Description
Surgeon questionnaire, the questionnaire qualitatively assesses nine items, each item scoring from "not at all" to "very much", evaluated individually
Time Frame
48 hours after surgery
Title
Assessment of oncological outcomes: Frequency of Overall survival (OS)
Description
The overall survival of all patients is assessed between operation date to date of death of any cause
Time Frame
24 months
Title
Assessment of oncological outcomes: Frequency of Progression Free survival (PFS)
Description
The progression free survival of all patients is assessed between operation date to date of tumor progression
Time Frame
24 months
Title
Assessment of oncological outcomes: Frequency of Loco-Regional Tumor Free Survival (LRFS)
Description
The Loco-Regional Tumor Free Survival of all patients is assessed between operation date to date of local tumor relapse
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 appendectomy, cholecystectomy or Cesarean section
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marius Distler, Prof. Dr.
Phone
+49 351 458 4098
Email
marius.distler@ukdd.de
First Name & Middle Initial & Last Name or Official Title & Degree
Fiona Kolbinger, Dr.
Phone
+49 351 458 4098
Email
fiona.kolbinger@ukdd.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marius Distler, Prof. Dr.
Organizational Affiliation
University Hospital Carl Gustav Carus Dresden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Visceral, Thoracic and Vascular Surgery University Hospital Carl Gustav Carus Technische Universität Dresden
City
Dresden
State/Province
Saxony
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marius Distler, Prof. Dr.
Email
marius.distler@ukdd.de

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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