Ergonomic Benefits From Robotically Assisted Laparoscopy for Hysterectomies and Other Indications

Musculoskeletal Diseases or Conditions Clinical Trial

— ERCON  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06109753
• Other study ID #: MT_ASENSUS SOS
• Status: Recruiting
• Start date: June 1, 2023
• Est. completion date: June 1, 2026

Study information

• Verified date: October 2023
• Source: University Hospital Tuebingen
• Contact: Bernhard Krämer, Prof. Dr.
• Phone: : +49 7071 29 82211
• Email: bernhard.kraemer[@]med.uni-tuebingen.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4
• Est. completion date: June 1, 2026
• Est. primary completion date: June 1, 2025
• Gender: All
• Age group: 18 Years to 68 Years

Eligibility

Inclusion Criteria:

• Age between 18 and 68 years
• surgeons that are able to work in full shift
• trained surgeons in RALS and CLS
• written informed consent

Exclusion Criteria:

• persons influenced by analgesics or muscle relaxants
• persons not able to perform their common work for any reason
• persons with acute diseases
• muscle injury

Related Conditions & MeSH terms

• Musculoskeletal Diseases
• Musculoskeletal Diseases or Conditions

Intervention

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
• 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

Locations

Country	Name	City	State
Germany	University Women's Hospital	Tübingen	Baden-Württemberg

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Tuebingen	Institute of Occupational and Social Medicine and Health Services Research, Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Musculoskeletal complaints	The Nordic Questionnaire encompasses an evaluation of diverse parameters, including body height (measured in centimeters), body weight (measured in kilograms), physical activity (assessed in hours of sports per week), work experience (measured in years), and the presence of musculoskeletal complaints within the last 12 months, along with point prevalence [n]. This holistic assessment offers critical insights into the participants' physical condition and occupational health status.; Additionally, please note that the Nordic Questionnaire does not specifically employ a single scale; rather, it utilizes various metrics tailored to the different parameters, and thus, the measurement scales can differ based on the specific parameter being assessed.	within the last 12 months
Other	Duration of the surgical procedure	The duration of the surgical procedure is a critical outcome measure, recorded in minutes, providing a precise indication of the time taken to complete the specific surgical intervention, aiding in the assessment of surgical efficiency and time management.	105 Minutes
Other	Difficulty of the surgery	The perceived difficulty of the surgery is measured using a visual analogue scale ranging from 0 to 100 mm, with 0 indicating that the surgery was not difficult and 100 indicating that the surgery was very difficult. This measure allows the surgeons to subjectively express the complexity and challenges associated with the performed surgical procedure.	5 Minutes
Primary	Muscle activity of the bilateral trapezius pars descendens muscle	The muscle activity of the bilateral trapezius pars descendens muscle will be assessed using surface electromyography, with the root-mean-square (RMS) of electrical muscle activity recordings measured through bipolar surface electrodes. Data will be normalized to an isometric voluntary maximum electrical activation (MVE).	during surgery
Secondary	Muscle activity of the bilateral forearm muscles	The muscle activity of the bilateral forearm muscles will be assessed using surface electromyography, with the root-mean-square (RMS) of electrical muscle activity recordings measured through bipolar surface electrodes. Data will be normalized to an isometric voluntary maximum electrical activation (MVE).	during surgery
Secondary	Kinematics	For kinematics, the outcome measures involve the assessment of shoulder abduction, trunk, and head flexion angles in degrees, which are determined using gravimetric position sensors, providing precise measurements of body positioning during the task.	during surgery
Secondary	Perceived physical discomfort	Perceived physical discomfort is evaluated by assessing its frequency and intensity. Frequency indicates the number of occurrences, while intensity is measured on a 0 to 10 scale, where higher values indicate more intense discomfort. These measurements are recorded at 20-minute intervals to monitor changes in discomfort over time.	during surgery
Secondary	Perceived mental demand	Perceived mental demand is evaluated using the NASA (National Aeronautics and Space Administration ) Task Load Index (TLX) questionnaire's mental demand dimension, providing a subjective score ranging from 0 to 21, reflecting the perceived cognitive load during the task. Higher values are representing higher perceived mental demand.	during surgery
Secondary	Perceived mental demand - Heart rate	Heart rate (beats per minute) and heart rate variability, such as SDNN (standard deviation of the beat-to-beat differences in instantaneous heart rate), are recorded via electrocardiography to quantify physiological responses associated with mental demand.	during surgery
Secondary	Perceived mental demand - Heart rate variability	Heart rate variability, to be precise SDNN (standard deviation of the beat-to-beat differences in instantaneous heart rate), are recorded via electrocardiography to quantify physiological responses associated with mental demand.	during surgery
Secondary	Work precision	Work precision is measured during surgery using a visual analogue scale ranging from 0 to 100 mm, providing an indication of the precision and accuracy of the surgical maneuvers performed.	during surgery
Secondary	Eye strain	Eye strain is evaluated using a 10-item questionnaire designed to assess the severity of eye strain, with each question scored on a scale from 0 to 6, aiding in the comprehensive understanding of the subjective experience of visual discomfort.	during surgery