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 volunteersQualifiers
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
Cohort
Other
Treatments tested in this trial
Surgery with intraoperative imaging
Procedure/Surgerylaparoscopic, robot-assisted or other intraoperative imaging (ultrasound, CT, MRI)
Treatment groups
Trial outcomes
Primary outcomes
Incidence of intraoperative technical errors of the applied assistance system
Major technical errors: system crash, calculation latency \> 1 second, Image distortions
Secondary outcomes
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.
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.
Operating time [min]
Time from skin incision until placement of last skin staple/suture
Duration of postoperative hospital stay [days]
Postoperative day 1 until day of discharge
Sponsors and contacts
Click on the lead sponsor to view all of their trials.