Knot Tying Surgical Simulator for Vessel Ligation

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03688997
• Other study ID #: 2646-15-SMC
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: August 2018

Study information

• Verified date: September 2018
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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:

Related Conditions & MeSH terms

• Surgery

Intervention

Other:
• Simulator training
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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Less extent of force while knot tying for vessel ligation	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.
Secondary	Identify peak force while knot tying for vessel ligation	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.