Development, Intraoperative Demonstration and Visualization of Surgical Assistance Functions

Study Overview
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Brief Summary
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The aim of the planned study is the development of surgical assistance functions on the basis of clinical routine data and the evaluation of the technical feasibility of an intraoperative demonstration and visualization of such assistance functions in visceral surgery. Furthermore, this trial aims to provide preliminary data on the clinical outcome of such assistance systems.

Detailed Description
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The aim of the clinical trial is to create the conditions for the comprehensive scientific use of new technologies such as augmented and virtual reality, computer-aided navigation and robotics in surgery in order to use these technologies in the future for improved surgical therapy for the benefit of the patient and to support the treating surgical team. The IDEMONSTRATE study is divided into two study parts: the development of a surgical assistance function based on routinely collected clinical (image) data that displays the position of anatomical structures (e.g. blood vessels, organs, tumors) in real time and the technical evaluation of this assistance system in the clinical environment. For the development of the surgical assistance function, data routinely collected as part of surgical inpatient treatment will be used. For research purposes (and explicitly not to prepare for approval as a medical device), a surgical assistance function is to be developed from this that displays the position of anatomical structures in real time during visceral surgical interventions. This system will then be evaluated in the second part of the study with regard to its technical feasibility and medical relevance. For the evaluation of the developed assistance function in the context of clinical treatment, the patients and the staff involved will be informed separately. All patients who are eligible for inclusion in the evaluating part of the study are fully capable of giving their consent. All doctors who will take part in the evaluation of the developed algorithm in a clinical context are specialists in general or visceral surgery; these doctors are informed in detail about the risks and sources of error in the context of the application before the developed algorithm and the associated assistance function is used. The evaluation of the developed assistance function takes place exclusively in the context of planned interventions, not in emergency situations.

Official Title
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Development, Intraoperative Demonstration and Visualization of Surgical Assistance Functions

Conditions
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Abdominal Surgery

Intervention / Treatment
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* Procedure: Surgery with intraoperative imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Indication for surgery using a laparoscopic or open surgical camera, a surgical robot (e.g., DaVinci system), or an intraoperative imaging modality (e.g. sonography, intraoperative CT) Patient understands German Exclusion Criteria: Lack of ability to consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Surgery with intraoperative imaging|laparoscopic, robot-assisted or other intraoperative imaging (ultrasound, CT, MRI)|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of intraoperative technical errors of the applied assistance system | Major technical errors: system crash, calculation latency > 1 second, Image distortions | during surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of surgical skills | The IDEMONSTRATE skill assessment scale v1.0 will be used to rate surgical skill on a scale from 1 to 5, with higher scores indicating higher skill levels. | during surgery | 
| Display accuracy of guidance functions | The IDEMONSTRATE display accuracy scale v1.0 will be used to rate display accuracy on a scale from 1 to 5, with higher scores indicating better display accuracy. | during surgery | 
| 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 | 
| Frequency of peri-operative morbidity after resection | Frequency of peri-operative complications after surgery | At day of discharge, assessed up to 90 days | 
| Kind of peri-operative morbidity after resection | Kind of peri-operative complications after surgery | At day of discharge, assessed up to 90 days | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Surgical data science, computer vision