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

Study Overview
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Brief Summary
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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.

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

Conditions
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Rectum Cancer

Intervention / Treatment
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* Other: Additional visualisation of surgical assistance during surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Additional visualisation of surgical assistance during surgery<br> | Other: Additional visualisation of surgical assistance during surgery<br>* 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<br>|

What is the study measuring?
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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 | 
| Duration of postoperative hospital stay [days] | Postoperative day 1 until day of discharge | At day of discharge, assessed up to 90 days | 
| 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 | 
| 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 | 
| Rectal sphincter function before and after rectal resection | Sphincter function will be assessed by manometry preoperatively and 12 - 24 months postoperatively | 24 months | 
| Frequency of peri-operative morbidity after resection | Frequency of peri-operative complications after surgery | 24 months | 
| Kind of peri-operative morbidity after resection | Kind of peri-operative complications after surgery | 24 months | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Robotic Surgery, Total mesorectal excision