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

Rectum Cancer Clinical Trial

— CoBot2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05652361
• Other study ID #: VTG-13
• Status: Recruiting
• Phase: N/A
• Start date: May 19, 2021
• Est. completion date: April 30, 2028

Study information

• Verified date: February 2024
• Source: Technische Universität Dresden
• Contact: Marius Distler, Prof. Dr.
• Phone: +49 351 458 4098
• Email: marius.distler[@]ukdd.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 30, 2028
• Est. primary completion date: July 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rectal Neoplasms
• Rectum Cancer

Intervention

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

Locations

Country	Name	City	State
Germany	Department of Visceral, Thoracic and Vascular Surgery University Hospital Carl Gustav Carus Technische Universität Dresden	Dresden	Saxony

Sponsors (2)

Lead Sponsor	Collaborator
Technische Universität Dresden	Deutsches Krebsforschungszentrum (DKFZ)

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Operating time [min]	Time from skin incision until placement of last skin staple/suture	During Surgery
Secondary	Duration of postoperative hospital stay [days]	Postoperative day 1 until day of discharge	At day of discharge, assessed up to 90 days
Secondary	Duration of postoperative intermediate/intensive care unit stay [days]	Postoperative day 1 until day of discharge	At day of discharge, assessed up to 90 days
Secondary	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).	24 months
Secondary	Rectal sphincter function before and after rectal resection	Sphincter function will be assessed by manometry preoperatively and 12 - 24 months postoperatively	24 months
Secondary	Frequency of peri-operative morbidity after resection	Frequency of peri-operative complications after surgery	24 months
Secondary	Kind of peri-operative morbidity after resection	Kind of peri-operative complications after surgery	24 months
Secondary	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	48 hours after surgery
Secondary	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
Secondary	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	24 months
Secondary	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	24 months
Secondary	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	24 months