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Clinical Trial Summary

This is a prospective, single-center, observational clinical trial at the Department of Women's Health of the University Hospital Tübingen.


Clinical Trial Description

Monocentric trial to evaluate differences in musculoskeletal and cognitive demands of robot-assisted laparoscopic surgery (RALS) vs. conventional laparoscopic surgery (CLS). Demographic and personal data are collected and pseudonymized. During surgery surface electromyography (EMG), electrocardiography (ECG), motion tracking data are collected and the surgery is documented by photos (1 photo/per second). Additionally, perceived physical discomfort (frequency and intensity) and mental load will be assessed within certain time intervals and at the very end of the surgery. The surgeon will not be disturbed in his actions and movement by the measurement equipment or applied procedures. Previous studies with similar designs can be seen as references in this context (549/2012BO1, 409/2013BO1, 262/2018BO1). After completing the surgery, the surgeon will rate difficulty of the surgery, work precision, eye strain and ergonomics during the surgery. Routine interventions like hysterectomies and other selected indications will be analyzed. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06109753
Study type Observational
Source University Hospital Tuebingen
Contact Bernhard Krämer, Prof. Dr.
Phone : +49 7071 29 82211
Email bernhard.kraemer@med.uni-tuebingen.de
Status Recruiting
Phase
Start date June 1, 2023
Completion date June 1, 2026

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