Questi studi valutano il carico di lavoro fisico ed ergonomico dei chirurghi. Lo Studio 1 confronta gli approcci laparoscopico vs. robotico Hugo RAS per la resezione rettale. Lo Studio 2 confronta Hugo RAS vs. Da Vinci Xi per la prostatectomia. Entrambi monitorano lo stress fisiologico, le fasi di sforzo chirurgico e la forza esercitata. (ERGOROB)
Il Progetto ERGOROB (ERGOnomica in Chirurgia ROBotica)
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.
Panoramica dello studio
Stato
Stato
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Tipo di studio
Tipo di studio
Iscrizione (Stimato)
Iscrizione
Fase
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
Contatto studio
- Nome: Matteo Rottoli, MD, PhD
- Numero di telefono: +390512144807
- Email: matteo.rottoli@unibo.it
Criteri di partecipazione
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Numero di armi
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
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Sperimentale: Colorectal Surgeons
5 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. |
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. |
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Sperimentale: Urological Surgeons
5 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. |
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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Surgeon Muscle Activity (Root Mean Square)
Lasso di tempo: Intraoperatively
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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) |
Intraoperatively
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Surgeon Posture and Upper Limb Kinematics
Lasso di tempo: Continuously during each of the 10 surgical procedures per participating surgeon (real-time acquisition)
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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 |
Continuously during each of the 10 surgical procedures per participating surgeon (real-time acquisition)
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Surgeon Hand and Finger Manipulation Forces
Lasso di tempo: Continuously during each of the 10 surgical procedures per participating urological surgeon (real-time acquisition)
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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. |
Continuously during each of the 10 surgical procedures per participating urological surgeon (real-time acquisition)
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Surgeon Muscle Fatigue (Median Frequency)
Lasso di tempo: Intraoperatively
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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) |
Intraoperatively
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Surgeon Muscle Strain (Sustained Activation)
Lasso di tempo: Intraoperatively
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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) |
Intraoperatively
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Collaboratori e investigatori
Sponsor
Sponsor
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
- 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.
- 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.
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Inizio studio (Stimato)
Inizio studio
Completamento primario (Stimato)
Completamento primario
Completamento dello studio (Stimato)
Completamento dello studio
Date di iscrizione allo studio
Primo inviato
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Primo Inserito
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- ERGOROB
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Informazioni su farmaci e dispositivi, documenti di studio
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