Knot Tying Surgical Simulator for Vessel Ligation

NCT03688997 | Completed

• 1 other identifier: 2646-15-SMC
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Surgery

Keywords

simulator; knot tying; vessel ligation; surgical training

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Identify peak force while knot tying for vessel ligation

  Through study completion, an average of one year.

Study Arms (2)

Experts

EXPERIMENTAL

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

Novice

EXPERIMENTAL

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

Interventions

Simulator training OTHER

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).

Experts; Novice

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• residents within their first year of surgical residency
• attending physicians from general surgery, vascular surgery, cardio-thoracic surgery and gynecology services.

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Officials

• Imri Amiel, MD

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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).

Study Record Dates

• First Submitted: September 21, 2018
• First Posted: September 28, 2018
• Study Start: January 1, 2016
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: September 28, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share