Knot Tying Surgical Simulator for Vessel Ligation
Expert Surgeons Versus Novice Residents: Validating a Novel Knot Tying Simulator for Vessel Ligation
Panoramica dello studio
Descrizione dettagliata
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 di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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:
-
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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).
|
|
Sperimentale: 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).
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Less extent of force while knot tying for vessel ligation
Lasso di tempo: 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.
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Through study completion, an average of one year.
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Identify peak force while knot tying for vessel ligation
Lasso di tempo: 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.
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Imri Amiel, MD, Sheba Medical Center
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- 2646-15-SMC
Piano per i dati dei singoli partecipanti (IPD)
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