- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03688997
Knot Tying Surgical Simulator for Vessel Ligation
Expert Surgeons Versus Novice Residents: Validating a Novel Knot Tying Simulator for Vessel Ligation
Descripción general del estudio
Descripción detallada
The simulator is a bench-top simulator with computer acquired assessments, designed to allow novices to acquire basic surgical skills in knot tying. The simulator measures the forces used and applied on the tissue while ligating a vessel.
Each participant received instructions for approximately 10 minutes with a standardized and detailed explanation of the knot-tying technique. All knots were square knots (double-throw knot) using the same type of sutures (SOLFSILK 3.0). Participants were asked to tie two knots in four types: A superficial one hand square knot; A superficial two hand square knot; A deep one hand square knot; A deep two hand square knot.
For each knot six parameters were extracted from the sensor data: maximum upward force, maximum downward force, total upward force, total downward force, absolute non-zero force and performance time. Maximum force is the highest force applied during the knot tying.
Participants were not aware of what exact parameters the simulator was assessing. Novices were explained to avoid tissue rupture or loose knots. Knot integrity was evaluated by an investigator present during the simulation that discarded "air knots". Videos were reviewed by an investigator at post-study analysis to verify the appropriate technique and knot integrity.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- residents within their first year of surgical residency
- attending physicians from general surgery, vascular surgery, cardio-thoracic surgery and gynecology services.
Exclusion Criteria:
-
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Experts
For the novice group, the investigators recruited 30 residents within their first year of surgical residency (Post-Graduate Year [PGY]-1) in general surgery, vascular surgery, plastic surgery, orthopedic surgery, cardio-thoracic surgery, gynecology and urology. The intervention administered was the use of a simulator by the participants. |
bench-top simulator with computer acquired assessments, designed to allow novices to acquire basic surgical skills in knot tying.
The simulator measures the forces used and applied on the tissue while ligating a vessel.
Simulator training was included in both arms (expert and novice groups).
|
Experimental: Novice
The expert's group included 15 attending surgical faculty members in the general surgery, vascular surgery, cardio-thoracic surgery and gynecology services. The intervention administered was the use of a simulator by the participants. |
bench-top simulator with computer acquired assessments, designed to allow novices to acquire basic surgical skills in knot tying.
The simulator measures the forces used and applied on the tissue while ligating a vessel.
Simulator training was included in both arms (expert and novice groups).
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Less extent of force while knot tying for vessel ligation
Periodo de tiempo: Through study completion, an average of one year.
|
The simulator will measure the vertical forces (in Newton) exerted while tying 8 knots for vessel ligation.
|
Through study completion, an average of one year.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Identify peak force while knot tying for vessel ligation
Periodo de tiempo: Through study completion, an average of one year.
|
The simulator will measure the maximum upward force (in Newton) used while tying 8 knots for vessel ligation.
|
Through study completion, an average of one year.
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Imri Amiel, MD, Sheba Medical Center
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 2646-15-SMC
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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