NCT06109753

Ergonomic Benefits From Robotically Assisted Laparoscopy for Hysterectomies and Other Indications

Ergonomic Benefits From Robotically Assisted Laparoscopy for Hysterectomies and Other Selected Indications in Comparison to Conventional Laparoscopy - an Explorative Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 4 (actual)
• Sponsor: University Hospital Tuebingen · Academic / Other
• Sex: All
• Age: 18 Years – 68 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Musculoskeletal Diseases or Conditions

Interventions

Type	Name	Description
PROCEDURE	Robotically Assisted Laparoscopic Surgery	robotically assisted surgeries of about 60-minute duration with additional 30 min for preparing with the measurement equipment before surgery and 15 post evaluation of the corresponding surgery
PROCEDURE	Conventional Laparoscopic Surgery	conventional surgeries of about 60-minute duration with additional 30 min for preparing with the measurement equipment before surgery and 15 post evaluation of the corresponding surgery

Timeline

• Start date: 2023-06-01
• Primary completion: 2024-01-31
• Completion: 2024-01-31
• First posted: 2023-10-31
• Last updated: 2026-01-28

Locations

1 site across 1 country: Germany