Soft Skills and Surgical Performance
SSPSP
Do Soft Skills Predict Surgical Performance? Do Soft Skills Predict Surgical Performance? A Prospective Randomized Controlled Single Center Educational Trial Evaluating Predictors of Skill Acquisition in Virtual Reality Laparoscopy
1 other identifier
interventional
50
0 countries
N/A
Brief Summary
Background and hypothesis: Virtual reality (VR) training in minimal invasive surgery (MIS) is known to be feasible and beneficial in surgical residency. Research on stress- coping in surgical trainees indicate an additional impact of soft skills on VR- performance. Thus to hypothesize soft skills predicting surgical performance in a VR- setting. Method: A prospective randomized controlled single center educational trial was carried out to evaluate the impact of structured VR- training and defined soft skills such as self- efficacy, stress- coping and motivation on VR- performance.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2008
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 2, 2010
CompletedFirst Posted
Study publicly available on registry
June 4, 2010
CompletedJune 17, 2010
June 1, 2010
7 months
June 2, 2010
June 16, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
VR- performance after training
Outcome measurement comprised defined parameters of VR- performance including "time to complete task", economy of instrument motion" and "tissue damage" within the most complex module "diathermy cutting" as primary endpoint.
Three months
Interventions
Prospective randomization if 50 subjects to either three months of structured VR- training or no training; basic VR- skills assessment and a serial assessment of defined soft skills: self- efficacy, stress- coping and motivation prior to randomization; basic VR- skills measured within seven modules of the VR- simulator LapSim®: "camera and instrument navigation", "coordination", "grasping", "lifting and grasping", "clip applying" and "diathermy cutting" in different levels of difficulty- medium and hard referring to "time to complete task", "economy of instrument motion" and "tissue damage"; intervention group: sessions of 45 minutes each twice a week for three months; control group: no training
Eligibility Criteria
You may qualify if:
- surgical residency not exceeding the first year of surgical training
- limited experience in MIS (camera navigation in laparoscopic cholecystectomies only)
- informed consent to study procedures and publication of anonymized data
You may not qualify if:
- surgical residency exceeding the first year of surgical training
- experience in MIS exceeding camera navigation in laparoscopic cholecystectomies
- lack of informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Officials
- PRINCIPAL INVESTIGATOR
Iyad Hassan, MD
Department of Visceral-, Thoracic- and Vascular Surgery, Philipps- University Marburg, Germany
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 2, 2010
First Posted
June 4, 2010
Study Start
June 1, 2008
Primary Completion
January 1, 2009
Study Completion
May 1, 2009
Last Updated
June 17, 2010
Record last verified: 2010-06