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.
Ergonomics
De qué trata este estudio
El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.
- Tipo de estudio
- De intervención
- Fase
- No aplica
- Rango de edad
- 40 años - 55 años
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- Aceptados
- Participantes
- 10 Estimado
Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.
Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
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.
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
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.
Entiende la evaluación inicialTratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- Sin asignación al azar
- Enmascaramiento
- Sin enmascaramiento
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.
Other: surgical approach
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.
Other: surgical approach
surgical approach OTHER
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.
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Surgeon Muscle Activity (Root Mean Square)
Plazo: Intraoperatively
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)
Surgeon Posture and Upper Limb Kinematics
Plazo: Continuously during each of the 10 surgical procedures per participating surgeon (real-time acquisition)
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
Surgeon Hand and Finger Manipulation Forces
Plazo: Continuously during each of the 10 surgical procedures per participating urological surgeon (real-time acquisition)
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.
Surgeon Muscle Fatigue (Median Frequency)
Plazo: Intraoperatively
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)
Surgeon Muscle Strain (Sustained Activation)
Plazo: Intraoperatively
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)
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (0)
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No hay centros indicados. Usa el contacto oficial del estudio.
Equipo y fechas
- Patrocinador principal
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Inicio del estudio
- 1 dic 2026 Estimado
- Finalización primaria
- 1 may 2028 Estimado
- Finalización del estudio
- 1 jun 2028 Estimado
- Primera publicación
- 18 mar 2026 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
Título oficial del estudio
The ERGOROB Project (ERGOnomics in Surgical ROBotics)
Consulta a Wellness Clinical Research
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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026