Ergonomic Benefits From Robotically Assisted Laparoscopy for Hysterectomies and Other Indications

Recruiting

• Conditions: Musculoskeletal Diseases or Conditions
• Interventions: Procedure: Robotically Assisted Laparoscopic Surgery; Procedure: Conventional Laparoscopic Surgery

• Registration Number: NCT06109753
• Lead Sponsor: University Hospital Tuebingen

Brief 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.

Study Timeline

• Study Start: 2023-06-01
• Status Verified: 2023-10
• Study First Submitted: 2023-10-10
• Study First Submitted QC: 2023-10-25
• Last Update Submitted: 2023-10-25
• Study First Posted: 2023-10-31
• Last Update Posted: 2023-10-31
• Primary Completion: 2025-06-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 4

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Robotically Assisted Laparoscopy	Robotically Assisted Laparoscopic Surgery	Surgeons perform robot-assisted laparoscopic surgery
Conventional Laparoscopy	Conventional Laparoscopic Surgery	Surgeons perform conventional laparoscopic surgery

Primary Outcome Measures

Name	Time	Method
Muscle activity of the bilateral trapezius pars descendens muscle	during surgery	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).

Secondary Outcome Measures

Name	Time	Method
Kinematics	during surgery	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.
Muscle activity of the bilateral forearm muscles	during surgery	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).
Perceived physical discomfort	during surgery	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.
Perceived mental demand - Heart rate	during surgery	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.
Eye strain	during surgery	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.
Perceived mental demand	during surgery	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.
Perceived mental demand - Heart rate variability	during surgery	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.
Work precision	during surgery	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.

Trial Locations

Locations (1)

University Women's Hospital; 🇩🇪 Tübingen, Baden-Württemberg, Germany