Development, Intraoperative Demonstration and Visualization of Surgical Assistance Functions

Abdominal Surgery Clinical Trial

— IDEMONSTRATE  

Official title:

Development, Intraoperative Demonstration and Visualization of Surgical Assistance Functions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05268432
• Other study ID #: VTG-09
• Status: Recruiting
• Start date: May 19, 2021
• Est. completion date: December 31, 2050

Study information

• Verified date: June 2024
• Source: Technische Universität Dresden
• Contact: Marius Distler, Prof. Dr.
• Phone: +49 351045818264
• Email: marius.distler[@]ukdd.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2050
• Est. primary completion date: December 31, 2050
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Surgery

Intervention

Procedure:
• Surgery with intraoperative imaging
laparoscopic, robot-assisted or other intraoperative imaging (ultrasound, CT, MRI)

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität Dresden

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of intraoperative technical errors of the applied assistance system	Major technical errors: system crash, calculation latency > 1 second, Image distortions	during surgery
Secondary	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
Secondary	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
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	Frequency of peri-operative morbidity after resection	Frequency of peri-operative complications after surgery	At day of discharge, assessed up to 90 days
Secondary	Kind of peri-operative morbidity after resection	Kind of peri-operative complications after surgery	At day of discharge, assessed up to 90 days
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