Knot Tying Surgical Simulator for Vessel Ligation

Sponsor

Sheba Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT03688997

Collaborator

(none)

Enrollment

Arms

Actual Duration (Months)

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Surgery	Other: Simulator training	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

45 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

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).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).

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Jan 1, 2016

Actual Primary Completion Date :

Aug 1, 2018

Actual Study Completion Date :

Aug 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
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.	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).
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.	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).

Arm

Intervention/Treatment

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.

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).

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.

Other: Simulator training

Outcome Measures

Primary Outcome Measures

Less extent of force while knot tying for vessel ligation [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.

Secondary Outcome Measures

Identify peak force while knot tying for vessel ligation [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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:

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Sheba Medical Center

Investigators

Principal Investigator: Imri Amiel, MD, Sheba Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr. Imri Amiel, Principal Investigator, Sheba Medical Center

ClinicalTrials.gov Identifier:

NCT03688997

Other Study ID Numbers:

2646-15-SMC

First Posted:

Sep 28, 2018

Last Update Posted:

Sep 28, 2018

Last Verified:

Sep 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Dr. Imri Amiel, Principal Investigator, Sheba Medical Center

Study Results

No Results Posted as of Sep 28, 2018