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Knot Tying Surgical Simulator for Vessel Ligation

Expert Surgeons Versus Novice Residents: Validating a Novel Knot Tying Simulator for Vessel Ligation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03688997
Enrollment
45
Registered
2018-09-28
Start date
2016-01-31
Completion date
2018-08-31
Last updated
2018-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgery

Keywords

simulator, knot tying, vessel ligation, surgical training

Brief summary

The investigators developed a bench-top knot tying simulator (KNOTI), with computer acquired assessment. Fifteen attending surgeons and 30 first year surgical residents were recruited to the study held at tertiary medical center during the years 2017-2018. The participants tied eight knots in different settings (Superficial vs. Deep) and techniques (One hand vs. two hands).

Detailed description

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.

Interventions

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).

Sponsors

Sheba Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Intervention model description

Fifteen attending surgeons and 30 first year surgical residents were recruited to the study held at tertiary medical center during the years 2016-2017. The participants tied eight knots in different settings (Superficial vs. Deep) and techniques (One hand vs. two hands).

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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

\-

Design outcomes

Primary

MeasureTime frameDescription
Less extent of force while knot tying for vessel ligationThrough study completion, an average of one year.The simulator will measure the vertical forces (in Newton) exerted while tying 8 knots for vessel ligation.

Secondary

MeasureTime frameDescription
Identify peak force while knot tying for vessel ligationThrough 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026