These Studies Assess Surgeons' Physical and Ergonomic Workloads. Study 1 Compares Laparoscopic vs. Hugo RAS Robotic Approaches for Rectal Resection. Study 2 Compares Hugo RAS vs. Da Vinci Xi for Prostatectomy. Both Track Physiological Stress, Surgical Strain Phases, and Exerted Force.

N/ANot Yet RecruitingNCT07479121

IRCCS Azienda Ospedaliero-Universitaria di Bologna10 enrolled

Overview

The ERGOROB (ERGOnomics in surgical ROBotics) study is an observational research project focused on the physical well-being of surgeons.Why is this study important?Surgeons perform complex, lengthy procedures that can lead to severe physical strain, awkward postures, and repetitive movements.This physical burden often causes musculoskeletal disorders, which can negatively impact a doctor's health and potentially shorten their career.By objectively measuring these physical demands, researchers aim to improve the design of surgical systems and training protocols.Preserving a surgeon's health and expertise ultimately enhances the quality of care provided to patients.What exactly is being studied?The research is divided into two comparative areas:Study 1: Compares the physical strain on doctors performing bowel surgery (Low Anterior Resection of the Rectum) using standard "keyhole" (laparoscopic) methods versus a robotic-assisted system called the Hugo RAS.Study 2: Compares the physical demands of using two different robotic surgical platforms (the Hugo RAS and the Da Vinci Xi) during prostate surgery (Radical Prostatectomy).What does this mean for patients?In this specific study, the surgeons are the subjects being evaluated, not the patients.Patients receive their standard, planned surgical treatment without any alterations.During the operation, the participating surgeon will wear specialized wireless equipment, including a 3D motion capture suit, muscle activity sensors, and sensorized gloves to measure hand force.The procedure is also video recorded to analyze the surgeon's movements and workflow.All wearable equipment has been thoroughly pre-tested in a simulated environment to guarantee it does not interfere with the surgeon's dexterity or comfort while operating.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Interventions

surgical approachOTHER

This study evaluates the ergonomic impact of different surgical platforms on operating surgeons. The "interventions" are the surgical systems used during standard procedures:Study 1: Compares the standard laparoscopic approach (control) versus the Medtronic Hugo™ RAS robotic system during Low Anterior Resection of the Rectum.Study 2: Directly compares the Medtronic Hugo™ RAS system versus the Intuitive da Vinci® Xi System during Radical Prostatectomy.Distinguishing Feature: Unlike trials focused on patient outcomes, the surgeon is the subject of investigation here. During live surgeries, surgeons are continuously monitored using wearable assessment tools: Xsens 3D Motion Capture suits for posture and kinematics , WaveX wireless sEMG sensors for muscle activity and fatigue , and GRIP VERSATEK sensorized gloves (Study 2 only) for hand force. This enables real-time, objective ergonomic data collection.

Eligibility

Sex: ALLMin age: 40 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Must be an experienced general surgeon specializing in colorectal surgery (Study 1) OR an experienced urological surgeon (Study 2). * Age between 40 and 55 years for colorectal surgeons, or between 40 and 50 years for urological surgeons. * For Study 1: Proficient in performing Low Anterior Resection of the Rectum using both standard laparoscopic techniques and the Hugo RAS robotic system, with over 30 robotic and laparoscopic procedures completed. * For Study 2: Expertise in robotic-assisted Radical Prostatectomy using both the Hugo RAS and Da Vinci Xi systems, with over 20 radical prostatectomies performed on both platforms. * Willingness to undergo extensive data collection during surgical procedures. * Provide written informed consent. Exclusion Criteria: \- None.

Outcomes

Primary Outcomes

Surgeon Muscle Activity (Root Mean Square)

Assessment of surgeon muscle workload measured using WaveX wireless surface electromyography (sEMG) sensors placed on the trapezius, erector spinae, biceps brachii, and forearm extensor muscles. The parameter evaluated is the Root Mean Square (RMS) value for muscle activity. Measured continuously during each of the surgical procedures per participating surgeon. Unit of Measure: Microvolts (or specify your exact electrical potential unit)

Time frame: Intraoperatively

Surgeon Posture and Upper Limb Kinematics

Evaluation of the surgeon's physical exertion and ergonomic posture deviations. Measured using the Xsens 3D Motion Capture Suit. Specific parameters include trunk flexion and lateral bending angles, shoulder and elbow range of motion (ROM), and the frequency and amplitude of repetitive movements of the upper limbs

Time frame: Continuously during each of the 10 surgical procedures per participating surgeon (real-time acquisition)

Surgeon Hand and Finger Manipulation Forces

Assessment of the physical force exerted by the surgeon's hands when interacting with the robotic consoles (Hugo RAS vs. Da Vinci Xi). Measured using GRIP VERSATEK sensorized gloves. Parameters include peak forces, average forces, and force variability.

Time frame: Continuously during each of the 10 surgical procedures per participating urological surgeon (real-time acquisition)

Surgeon Muscle Fatigue (Median Frequency)

Assessment of surgeon muscle fatigue via spectral analysis, measured using WaveX wireless surface electromyography (sEMG) sensors placed on the trapezius, erector spinae, biceps brachii, and forearm extensor muscles. The parameter evaluated is the median frequency of the sEMG signals. Measured continuously during each surgical procedures per participating surgeon. Unit of Measure: Hertz (Hz)

Time frame: Intraoperatively

Surgeon Muscle Strain (Sustained Activation)

Assessment of surgeon muscle strain, measured using WaveX wireless surface electromyography (sEMG) sensors placed on the trapezius, erector spinae, biceps brachii, and forearm extensor muscles. The parameter evaluated is the duration of periods of sustained muscle activation and high levels of co-contraction. Measured continuously during each surgical procedures per participating surgeon. Unit of Measure: Seconds (or minutes)

Time frame: Intraoperatively

These Studies Assess Surgeons' Physical and Ergonomic Workloads. Study 1 Compares Laparoscopic vs. Hugo RAS Robotic Approaches for Rectal Resection. Study 2 Compares Hugo RAS vs. Da Vinci Xi for Prostatectomy. Both Track Physiological Stress, Surgical Strain Phases, and Exerted Force.

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Central Contacts