- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03688997
Knot Tying Surgical Simulator for Vessel Ligation
Expert Surgeons Versus Novice Residents: Validating a Novel Knot Tying Simulator for Vessel Ligation
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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:
-
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 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).
|
Experimentell: 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).
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Less extent of force while knot tying for vessel ligation
Tidsram: 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.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Identify peak force while knot tying for vessel ligation
Tidsram: 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.
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Imri Amiel, MD, Sheba Medical Center
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- 2646-15-SMC
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
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