Development, Intraoperative Demonstration and Visualization of Surgical Assistance Functions

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTechnische Universität Dresden

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Lack of ability to consent

Trial 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).

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • Surgery with intraoperative imaging

    Procedure/Surgery

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

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Incidence of intraoperative technical errors of the applied assistance system

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

Time frame
during surgery

Secondary outcomes

1

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.

Time frame
during surgery
2

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.

Time frame
during surgery
3

Operating time [min]

Time from skin incision until placement of last skin staple/suture

Time frame
during surgery
4

Duration of postoperative hospital stay [days]

Postoperative day 1 until day of discharge

Time frame
At day of discharge, assessed up to 90 days

Other outcomes

Sponsors and contacts

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