NCT03758586

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 24, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 29, 2018

Completed
Last Updated

November 29, 2018

Status Verified

November 1, 2018

Enrollment Period

8 months

First QC Date

November 24, 2018

Last Update Submit

November 27, 2018

Conditions

Outcome Measures

Primary Outcomes (2)

  • Tissue piercing

    Number of times tissue was pierced during suturing

    up to 2 hours from enrollment

  • Tissue tearing

    Number of times tissue was teared during suturing

    up to 2 hours from enrollment

Study Arms (2)

Study group

ACTIVE COMPARATOR

Surgical residents undergoing spatial skill training.

Other: Computerized spatial skill training

Control group

SHAM COMPARATOR

Surgical residents not undergoing spatial skill training.

Other: Watching a presentation regarding robotic surgery

Interventions

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.

Study group

Watching a 20-35 minute long power-point presentation regarding the history of robotic surgery.

Control group

Eligibility Criteria

Age25 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Surgical Residents with no previous robotic surgery experience.

You may not qualify if:

  • Non surgical residents.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam health care campus

Haifa, Israel

Location

MeSH Terms

Conditions

Spatial Learning

Condition Hierarchy (Ancestors)

Spatial BehaviorBehavior

Study Officials

  • Roy Lauterbach, MD

    Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 24, 2018

First Posted

November 29, 2018

Study Start

January 1, 2017

Primary Completion

September 1, 2017

Study Completion

January 1, 2018

Last Updated

November 29, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations