- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01712607
Preoperative Warm-up in Gynecologic Surgery
Preoperative Warm-up in Gynecologic Surgery Using a Virtual Reality Simulator.
Background and Objectives: All modern surgical procedures require a high level of cognitive and psychomotor skills achieved using different training methods, but could be influenced by fatigue and other psychological factors. We evaluate the effect of warm-up exercises on operative laparoscopic performances in gynecologic laparoscopic procedures.
Methods: The surgical team operates on a consecutive series of 20 patients and perform laparoscopic salpingo-oophorectomy. Patients are randomly allocated in 2 groups: group A to be operated on without warm-up exercises and group B to be operated on after a short-term warm-up. All patients are operated on by the same surgical team. The full-time records of the operation were analyzed by 2 independent reviewers. Laparoscopic procedures are recorded and assessed by 2 independent observers using the generic OSATS rating scale. A training module using the Lap Sim simulator was designed for the warm-up.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
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Vienna, Austria, 1090
- Dept. Gynecology and Obstetrics, Medical University of Vienna, Austria
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- residents or faculty at the Dept. of Gynecology and Obstetrics
- completed skills training
Exclusion Criteria:
- none
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Warm-Up
Surgery after warm-up task Preoperative Warm-Up training
|
Preoperative Warm-Up training
|
|
No Intervention: No Warm-up
Surgery without warm-up exercise
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Surgical performance
Time Frame: During surgery
|
Surgical Performance will be assessed using Objective structured assessment of technical skills (OSATS)
|
During surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Stephan Polterauer, Medical University of Vienna
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Warm-Up-1.0
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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