Ergonomic Benefits From Robotically Assisted Laparoscopy for Hysterectomies and Other Indications (ERCON)

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

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

Study Overview

• Status: Recruiting
• Conditions: Musculoskeletal Diseases or Conditions
• Intervention / Treatment: Procedure: Robotically Assisted Laparoscopic Surgery; Procedure: Conventional Laparoscopic Surgery

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.

• Study Type: Observational
• Enrollment (Estimated): 4

Contacts and Locations

• Study Contact: Name: Bernhard Krämer, Prof. Dr.; Phone Number: : +49 7071 29 82211; Email: bernhard.kraemer@med.uni-tuebingen.de

Study Locations

• Germany
  • Baden-Württemberg
    • Tübingen, Baden-Württemberg, Germany, 72076
      • Recruiting
      • University Women's Hospital
      • Contact: Bernhard Krämer, Prof. Dr.; Email: bernhard.kraemer@med.uni-tuebingen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

4 (males and females) gynecological surgeons

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Robotically Assisted Laparoscopy; Surgeons perform robot-assisted laparoscopic surgery	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 Laparoscopy; Surgeons perform conventional laparoscopic 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: University Hospital Tuebingen
• Collaborators: Institute of Occupational and Social Medicine and Health Services Research, Tuebingen
• Investigators: Principal Investigator: Benjamin Steinhilber, PD Dr., Institute of Occupational and Social Medicine and Health Services Research; Principal Investigator: Bernhard Krämer, Prof. Dr., University Women's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: October 10, 2023
• First Submitted That Met QC Criteria: October 25, 2023
• First Posted (Actual): October 31, 2023

Study Record Updates

• Last Update Posted (Actual): October 31, 2023
• Last Update Submitted That Met QC Criteria: October 25, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: eye strain; Muscular and mental demand; physical discomfort
• Additional Relevant MeSH Terms: Musculoskeletal Diseases
• Other Study ID Numbers: MT_ASENSUS SOS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No