AzTrials
AzTrials

ErgonomicsERGOROBNCT07479121

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.

A study testing surgical approach in people with Ergonomics, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 40 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Ergonomics
What is being tested?
surgical approach
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
No sites listed yet
Study dates
1 Apr 2026to 1 Jun 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • None.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Matteo Rottoli, MD, PhD contact

+390512144807

matteo.rottoli@unibo.it

About this study

Official title: The ERGOROB Project (ERGOnomics in Surgical ROBotics)

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.

Conditions
Ergonomics
Being tested
surgical approach
Keywords
Robotic surgery, Urology, Colorectal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT07479121
Study groupRoleWhat they receive
Colorectal SurgeonsExperimental5 experienced colorectal surgeons acting as their own controls. Each surgeon will perform 10 procedures: 5 using the standard laparoscopic approach and 5 using the Hugo RAS robotic system.
Receives: Other: surgical approach
Urological SurgeonsExperimental5 experienced urological surgeons acting as their own controls. Each surgeon will perform 10 procedures: 5 using the Hugo RAS robotic system and 5 using the Da Vinci Xi robotic system.
Receives: Other: surgical approach

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Intraoperatively

  2. 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

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

  3. 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.

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

  4. 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)

    Measured: Intraoperatively

  5. 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)

    Measured: Intraoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2026
  2. Study start1 Apr 2026 (estimated)
  3. Primary completion1 May 2028 (estimated)
  4. Study completion1 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07479121
Sponsor's protocol ID
ERGOROB
Acronym
ERGOROB
Status last verified
Mar 2026
First submitted
10 Mar 2026
Last updated
18 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Burdorf A, Naaktgeboren B, de Groot HC. Occupational risk factors for low back pain among sedentary workers. J Occup Med. 1993 Dec;35(12):1213-20.

    PubMed 8113925

  • Aghilinejad M, Ehsani AA, Talebi A, Koohpayehzadeh J, Dehghan N. Ergonomic risk factors and musculoskeletal symptoms in surgeons with three types of surgery: Open, laparoscopic, and microsurgery. Med J Islam Repub Iran. 2016 Dec 28;30:467. eCollection 2016.

    PubMed 28491842

  • Epstein S, Sparer EH, Tran BN, Ruan QZ, Dennerlein JT, Singhal D, Lee BT. Prevalence of Work-Related Musculoskeletal Disorders Among Surgeons and Interventionalists: A Systematic Review and Meta-analysis. JAMA Surg. 2018 Feb 21;153(2):e174947. doi: 10.1001/jamasurg.2017.4947. Epub 2018 Feb 21.

    PubMed 29282463

Questions about this trial

What is this clinical trial studying?

A study testing surgical approach in people with Ergonomics, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Matteo Rottoli, MD, PhD (+390512144807, matteo.rottoli@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Surgeon Muscle Activity (Root Mean Square) (time frame: Intraoperatively). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07479121, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.

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