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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03758586
Other study ID # 0602-18-RMB
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2017
Est. completion date January 1, 2018

Study information

Verified date November 2018
Source Rambam Health Care Campus
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Surgical residents from a single tertiary medical center were divided into 2 groups. All residents performed 2 tasks on a Da Vinci robotic simulator system after which they were either given a real training session in spatial skills (study group) or shown a short presentation regarding robotic surgery. After training/watching the presentation, they repeated the for mentioned tasks on the robotic simulator. Improvement in surgeon performance, especially regarding tissue damage was documented.


Description:

Importance: Robot-assisted surgery is becoming the mainstay of modern surgery. Efficient training techniques are essential for enhanced performance. Optimal performance during a surgical task is key to successful surgery and minimal adverse events.

Objective: To introduce and examine a single session of spatial skill training as an efficient means of improving surgical suturing performance in robot-assisted surgery.

Design: Forty-one surgical residents will be randomly assigned to training and control conditions. (1) participants will perform two da-Vinci skills simulator (dVSS) tasks to determine baseline performance. (2) the training group will undergo computer-based simulator training of spatial skills while the control group will engage in a neutral activity. (3) two dVSS tasks will be performed within 2 days of training completion to evaluate post-training performance. The experiment will be conducted until December 2018.

Participants: A convenience sample comprised of 41 surgical residents with non-robotic surgical suturing skills.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date January 1, 2018
Est. primary completion date September 1, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 25 Years to 40 Years
Eligibility Inclusion Criteria:

- Surgical Residents with no previous robotic surgery experience.

Exclusion Criteria:

- Non surgical residents.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Computerized spatial skill training
The spatial skills training session consisted of six practice trials that were run in a sequence. The objective of each practice was to manipulate the simulated robotic arm to grab the cubes and move them to a desired location using keyboard keys. The participant was required to reach a decision based on the visual-spatial information, before initiating subsequent movements of the simulated robotic arm. Each practice trial presented an initial state of the cubes in front of the robotic arm, and a target position of the cubes.
Watching a presentation regarding robotic surgery
Watching a 20-35 minute long power-point presentation regarding the history of robotic surgery.

Locations

Country Name City State
Israel Rambam health care campus Haifa

Sponsors (1)

Lead Sponsor Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Tissue piercing Number of times tissue was pierced during suturing up to 2 hours from enrollment
Primary Tissue tearing Number of times tissue was teared during suturing up to 2 hours from enrollment
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