Development, Intraoperative Demonstration and Visualization of Surgical Assistance Functions

NCT05268432 | Recruiting

• 1 other identifier: VTG-09
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdominal Surgery

Keywords

Surgical data science; computer vision

Outcome Measures

Primary Outcomes (1)

• Incidence of intraoperative technical errors of the applied assistance system

  Major technical errors: system crash, calculation latency \> 1 second, Image distortions

  during surgery

Secondary Outcomes (8)

• Evaluation of surgical skills

  during surgery

• Display accuracy of guidance functions

  during surgery

• Operating time [min]

  during surgery

• Duration of postoperative hospital stay [days]

  At day of discharge, assessed up to 90 days

• Duration of postoperative intermediate/intensive care unit stay [days]

  At day of discharge, assessed up to 90 days

Interventions

Surgery with intraoperative imaging PROCEDURE

laparoscopic, robot-assisted or other intraoperative imaging (ultrasound, CT, MRI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• Lack of ability to consent

Sponsors & Collaborators

• Technische Universität Dresden: lead

Study Sites (1)

Department of Gastrointestinal-, Thoracic and Vascular Surgery University Hospital Carl Gustav Carus Technische Universität Dresden

Dresden, Saxony, 01307, Germany

RECRUITING

MeSH Terms

Interventions

Surgical Procedures, Operative

Study Officials

• Marius Distler, Prof. Dr.

  Technical University Dresden

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marius Distler, Prof. Dr.

CONTACT

+49 351045818264; marius.distler@ukdd.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 90 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2022
• First Posted: March 7, 2022
• Study Start: May 19, 2021
• Primary Completion (Estimated): December 31, 2050
• Study Completion (Estimated): December 31, 2050
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)