Development, Intraoperative Demonstration and Visualization of Surgical Assistance Functions (IDEMONSTRATE)

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.

Study Overview

• Status: Recruiting
• Conditions: Abdominal Surgery
• Intervention / Treatment: Procedure: Surgery with intraoperative imaging

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.

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Marius Distler, Prof. Dr.; Phone Number: +49 351045818264; Email: marius.distler@ukdd.de

Study Locations

• Germany
  • Saxony
    • Dresden, Saxony, Germany, 01307
      • Recruiting
      • Department of Gastrointestinal-, Thoracic and Vascular Surgery University Hospital Carl Gustav Carus Technische Universität Dresden
      • Contact: Marius Distler, Prof. Dr.; Phone Number: +49 351 458 18264; Email: marius.distler@ukdd.de
      • Sub-Investigator: Fiona Kolbinger, Dr. med.
      • Sub-Investigator: Stefanie Speidel, Prof. Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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).

Description

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

Study Plan

How is the study designed?

What is the study measuring?

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
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 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
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
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

Collaborators and Investigators

• Sponsor: Technische Universität Dresden
• Investigators: Principal Investigator: Marius Distler, Prof. Dr., Technical University Dresden

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2021
• Primary Completion (Estimated): December 31, 2050
• Study Completion (Estimated): December 31, 2050

Study Registration Dates

• First Submitted: February 7, 2022
• First Submitted That Met QC Criteria: February 24, 2022
• First Posted (Actual): March 7, 2022

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: February 6, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: computer vision; Surgical data science
• Additional Relevant MeSH Terms: Surgical Procedures, Operative
• Other Study ID Numbers: VTG-09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Following publication of study results, de-identified patient data may be made available upon reasonable request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No