Clinical trial NCT05268432: Development, Intraoperative Demonstration and Visualization of Surgical Assistance Functions
Official title: Development, Intraoperative Demonstration and Visualization of Surgical Assistance Functions
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Abdominal Surgery
Keywords: Surgical data science
computer vision
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
First posted: 2022-03-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: This study will enroll patients undergoing surgery using a laparoscopic or open surgical camera, a surgical robot (e.g. DaVinci®), or intraoperative imaging technology (e.g. ultrasound, CT).

Brief summary: 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.

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

Primary outcomes:
measure: Incidence of intraoperative technical errors of the applied assistance system
timeFrame: during surgery
Secondary outcomes:
measure: Evaluation of surgical skills
timeFrame: during surgery
measure: Display accuracy of guidance functions
timeFrame: during surgery
measure: Operating time [min]
timeFrame: during surgery
measure: Duration of postoperative hospital stay [days]
timeFrame: At day of discharge, assessed up to 90 days
measure: Duration of postoperative intermediate/intensive care unit stay [days]
timeFrame: At day of discharge, assessed up to 90 days
measure: Frequency of peri-operative morbidity after resection
timeFrame: At day of discharge, assessed up to 90 days
measure: Kind of peri-operative morbidity after resection
timeFrame: At day of discharge, assessed up to 90 days
measure: Assessment of usability of guidance system
timeFrame: 48 hours after surgery
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Department of Gastrointestinal-, Thoracic and Vascular Surgery University Hospital Carl Gustav Carus Technische Universität Dresden
state: Saxony
Study officials:
affiliation: Technical University Dresden
name: Marius Distler, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: