Development, Intraoperative Demonstration and Visualization of Surgical Assistance Functions
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Surgery with intraoperative imaging.
- Who it may be relevant to
- Registry conditions: Abdominal Surgery. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
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.
Interventions
- Procedure Surgery with intraoperative imaging
laparoscopic, robot-assisted or other intraoperative imaging (ultrasound, CT, MRI)
Primary outcome measures
- Incidence of intraoperative technical errors of the applied assistance system [Time frame: during surgery]
Secondary outcome measures (8)
- Evaluation of surgical skills [Time frame: during surgery]
- Display accuracy of guidance functions [Time frame: during surgery]
- Operating time [min] [Time frame: during surgery]
- Duration of postoperative hospital stay [days] [Time frame: At day of discharge, assessed up to 90 days]
- Duration of postoperative intermediate/intensive care unit stay [days] [Time frame: At day of discharge, assessed up to 90 days]
- Frequency of peri-operative morbidity after resection [Time frame: At day of discharge, assessed up to 90 days]
- Kind of peri-operative morbidity after resection [Time frame: At day of discharge, assessed up to 90 days]
- Assessment of usability of guidance system [Time frame: 48 hours after surgery]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- Department of Gastrointestinal-, Thoracic and Vascular Surgery University Hospital Carl Gu — Dresden
Identifiers
NCT: NCT05268432 · VTG-09